Viewing Study NCT00996892

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Ignite Creation Date: 2025-12-24 @ 3:46 PM

Ignite Modification Date: 2025-12-30 @ 2:39 AM

Study NCT ID: NCT00996892

Status: TERMINATED

Last Update Posted: 2016-12-30

First Post: 2009-10-12

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574276', 'term': 'cobimetinib'}, {'id': 'C532162', 'term': '2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated prior to the initiation of Stage 2B and as per changes in planned analysis the data for duration of objective response and PFS were not analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)', 'description': 'Safety evaluable population.', 'eventGroups': [{'id': 'EG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.', 'otherNumAtRisk': 43, 'otherNumAffected': 42, 'seriousNumAtRisk': 43, 'seriousNumAffected': 25}, {'id': 'EG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.', 'otherNumAtRisk': 52, 'otherNumAffected': 52, 'seriousNumAtRisk': 52, 'seriousNumAffected': 28}, {'id': 'EG011', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 4}, {'id': 'EG012', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 5}, {'id': 'EG013', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}, {'id': 'EG014', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 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'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pneumonitits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-Limiting Toxicities (DLTs) During Dose Escalation Stages 1, 1A and 1B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '5', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG007', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG008', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG009', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG010', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG011', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG012', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG013', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG014', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG015', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG016', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG017', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28', 'description': 'DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non clinically significant (as assessed by Investigator) laboratory abnormality that was asymptomatic; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count \\<500/microliter) lasting \\>5 days; Grade ≥4 thrombocytopenia lasting \\>48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting \\>72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-evaluable population included all participants who received at least one dose of study drug. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Maximum Tolerated Combination Doses of Cobimetinib and Pictilisib During Dose-Escalation Stages 1, 1A and 1B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants - Stages 1, 1A, 1B', 'description': 'All participants who received cobimetinib and pictilisib in any dose combination during Stages 1, 1A, and 1B, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'title': 'Stage 1: Cobimetinib (n = 44)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Stage 1: Pictilisib (n = 44)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Stage 1A: Cobimetinib (n = 34)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}, {'title': 'Stage 1A: Pictilisib (n = 34)', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}]}]}, {'title': 'Stage 1B: Cobimetinib (n = 20)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'MTD for Stage 1B was not determined as the study was terminated prior to initiation of Stage 2B.', 'groupId': 'OG000'}]}]}, {'title': 'Stage 1B: Pictilisib (n = 20)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'MTD for Stage 1B was not determined as the study was terminated prior to initiation of Stage 2B.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28', 'description': 'MTD was determined (by Investigator) based on the DLTs, as well as adverse events (AEs) in dose-escalation Stages 1, 1A, and 1B that did not meet protocol-defined DLT criteria but indicated intolerability of a given dose combination. Separate combination MTDs were determined for each dose-escalation stage. DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count \\<500/microliter) lasting \\>5 days; Grade ≥4 thrombocytopenia lasting \\>48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting \\>72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants evaluable for specified categories.'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Concentration (Tmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-4 hours pre-cobimetinib (Pr-C) dose, 0.5, 2, 4, 6 hours post-cobimetinib (Po-C) dose on Day 3, Day 4', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population included all participants who had at least one cobimetinib and pictilisib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '95', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '78', 'groupId': 'OG001'}, {'value': '97.0', 'spread': '63', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve From Time 0 to 24 Hours Post-Dose (AUC0-24) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '392', 'spread': '88', 'groupId': 'OG000'}, {'value': '279', 'spread': '75', 'groupId': 'OG001'}, {'value': '1190', 'spread': '53', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4', 'unitOfMeasure': 'nonograms*hour per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Tmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '24.0'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-4 hours pre-pictilisib (Pr-P) dose, 0.5, 2, 4, 6 hours post-pictilisib (Po-P) dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '162', 'spread': '37', 'groupId': 'OG000'}, {'value': '185', 'spread': '27', 'groupId': 'OG001'}, {'value': '280', 'spread': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'AUC0-24 of Pictilisib on Day 1 - Stage 1, Cohorts 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1680', 'spread': '16', 'groupId': 'OG000'}, {'value': '1950', 'spread': '50', 'groupId': 'OG001'}, {'value': '2680', 'spread': '83', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '4.00', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '3.00', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'spread': '100', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '62', 'groupId': 'OG001'}, {'value': '87.4', 'spread': '73', 'groupId': 'OG002'}, {'value': '101', 'spread': '63', 'groupId': 'OG003'}, {'value': '61.0', 'spread': '45', 'groupId': 'OG004'}, {'value': '131', 'spread': '66', 'groupId': 'OG005'}, {'value': '138', 'spread': '61', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '299', 'spread': '62', 'groupId': 'OG000'}, {'value': '311', 'spread': '53', 'groupId': 'OG001'}, {'value': '1320', 'spread': '56.6', 'groupId': 'OG002'}, {'value': '1300', 'spread': '61', 'groupId': 'OG003'}, {'value': '957', 'spread': '42', 'groupId': 'OG004'}, {'value': '2050', 'spread': '71', 'groupId': 'OG005'}, {'value': '1790', 'spread': '56', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '3.0', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '4', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '52.2', 'spread': '57', 'groupId': 'OG001'}, {'value': '228', 'spread': '120', 'groupId': 'OG002'}, {'value': '167', 'spread': '56', 'groupId': 'OG003'}, {'value': '138', 'spread': '63', 'groupId': 'OG004'}, {'value': '245', 'spread': '79', 'groupId': 'OG005'}, {'value': '87.4', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '749', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '900', 'spread': '70', 'groupId': 'OG001'}, {'value': '4130', 'spread': '94', 'groupId': 'OG002'}, {'value': '2410', 'spread': '66', 'groupId': 'OG003'}, {'value': '2460', 'spread': '57', 'groupId': 'OG004'}, {'value': '4050', 'spread': '110', 'groupId': 'OG005'}, {'value': '1120', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (t1/2) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '60'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '43'}, {'value': '31.7', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '48'}, {'value': '34.1', 'groupId': 'OG003', 'lowerLimit': '32', 'upperLimit': '37'}, {'value': '43.2', 'groupId': 'OG004', 'lowerLimit': '34', 'upperLimit': '56'}, {'value': '45.7', 'groupId': 'OG005', 'lowerLimit': '41', 'upperLimit': '56'}, {'value': '40.5', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL/F) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '70', 'groupId': 'OG001'}, {'value': '9.67', 'spread': '94', 'groupId': 'OG002'}, {'value': '16.6', 'spread': '66', 'groupId': 'OG003'}, {'value': '16.2', 'spread': '61', 'groupId': 'OG004'}, {'value': '14.8', 'spread': '110', 'groupId': 'OG005'}, {'value': '53.6', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'Liters per hour (L/hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.51', 'spread': '63', 'groupId': 'OG000'}, {'value': '2.89', 'spread': '43', 'groupId': 'OG001'}, {'value': '3.14', 'spread': '73', 'groupId': 'OG002'}, {'value': '2.03', 'spread': '36', 'groupId': 'OG003'}, {'value': '2.90', 'spread': '73', 'groupId': 'OG004'}, {'value': '2.83', 'spread': '54', 'groupId': 'OG005'}, {'value': '1.77', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2, 22', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '196', 'spread': '20', 'groupId': 'OG000'}, {'value': '193', 'spread': '16', 'groupId': 'OG001'}, {'value': '329', 'spread': '26', 'groupId': 'OG002'}, {'value': '390', 'spread': '60', 'groupId': 'OG003'}, {'value': '302', 'spread': '34', 'groupId': 'OG004'}, {'value': '272', 'spread': '54', 'groupId': 'OG005'}, {'value': '355', 'spread': '83', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1660', 'spread': '28', 'groupId': 'OG000'}, {'value': '2150', 'spread': '43', 'groupId': 'OG001'}, {'value': '2600', 'spread': '28', 'groupId': 'OG002'}, {'value': '3360', 'spread': '43', 'groupId': 'OG003'}, {'value': '2770', 'spread': '43', 'groupId': 'OG004'}, {'value': '2870', 'spread': '48', 'groupId': 'OG005'}, {'value': '3240', 'spread': '68', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '2.00', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'spread': '38', 'groupId': 'OG000'}, {'value': '278', 'spread': '100', 'groupId': 'OG001'}, {'value': '459', 'spread': '20', 'groupId': 'OG002'}, {'value': '409', 'spread': '49', 'groupId': 'OG003'}, {'value': '374', 'spread': '69', 'groupId': 'OG004'}, {'value': '396', 'spread': '48', 'groupId': 'OG005'}, {'value': '441', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2500', 'spread': '21', 'groupId': 'OG000'}, {'value': '2930', 'spread': '150', 'groupId': 'OG001'}, {'value': '5500', 'spread': '34', 'groupId': 'OG002'}, {'value': '3890', 'spread': '63', 'groupId': 'OG003'}, {'value': '4320', 'spread': '58', 'groupId': 'OG004'}, {'value': '4510', 'spread': '40', 'groupId': 'OG005'}, {'value': '4070', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 't1/2 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '24.7', 'groupId': 'OG004', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '27.7', 'groupId': 'OG005', 'lowerLimit': '22', 'upperLimit': '41'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'spread': '21', 'groupId': 'OG000'}, {'value': '34.1', 'spread': '150', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '34', 'groupId': 'OG002'}, {'value': '25.7', 'spread': '63', 'groupId': 'OG003'}, {'value': '30.1', 'spread': '58', 'groupId': 'OG004'}, {'value': '22.2', 'spread': '40', 'groupId': 'OG005'}, {'value': '24.6', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.51', 'spread': '47', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '79', 'groupId': 'OG001'}, {'value': '2.11', 'spread': '6.0', 'groupId': 'OG002'}, {'value': '1.16', 'spread': '34', 'groupId': 'OG003'}, {'value': '1.71', 'spread': '29', 'groupId': 'OG004'}, {'value': '1.70', 'spread': '25', 'groupId': 'OG005'}, {'value': '2.8', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Day 2, 22', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '5.00', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '4.00', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '301', 'spread': '87', 'groupId': 'OG000'}, {'value': '137', 'spread': '66', 'groupId': 'OG001'}, {'value': '436', 'spread': '67', 'groupId': 'OG002'}, {'value': '184', 'spread': '47', 'groupId': 'OG003'}, {'value': '275', 'spread': '72', 'groupId': 'OG004'}, {'value': '333', 'spread': '45', 'groupId': 'OG005'}, {'value': '311', 'spread': '48', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4950', 'spread': '80', 'groupId': 'OG000'}, {'value': '2320', 'spread': '61', 'groupId': 'OG001'}, {'value': '5520', 'spread': '59', 'groupId': 'OG002'}, {'value': '2620', 'spread': '50', 'groupId': 'OG003'}, {'value': '4250', 'spread': '75', 'groupId': 'OG004'}, {'value': '5100', 'spread': '47', 'groupId': 'OG005'}, {'value': '5090', 'spread': '45', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '5.00', 'groupId': 'OG005', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '3.00', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '802', 'spread': '24', 'groupId': 'OG000'}, {'value': '372', 'spread': '45', 'groupId': 'OG001'}, {'value': '616', 'spread': '39', 'groupId': 'OG002'}, {'value': '204', 'spread': '57', 'groupId': 'OG003'}, {'value': '409', 'spread': '43', 'groupId': 'OG004'}, {'value': '475', 'spread': '86', 'groupId': 'OG005'}, {'value': '682', 'spread': '23', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '13400', 'spread': '18', 'groupId': 'OG000'}, {'value': '5680', 'spread': '55', 'groupId': 'OG001'}, {'value': '9990', 'spread': '28', 'groupId': 'OG002'}, {'value': '3060', 'spread': '50', 'groupId': 'OG003'}, {'value': '6980', 'spread': '55', 'groupId': 'OG004'}, {'value': '7740', 'spread': '69', 'groupId': 'OG005'}, {'value': '11100', 'spread': '23', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 't1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '46.1', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '67'}, {'value': '47.4', 'groupId': 'OG002', 'lowerLimit': '34', 'upperLimit': '63'}, {'value': '48.8', 'groupId': 'OG003', 'lowerLimit': '37', 'upperLimit': '63'}, {'value': '48', 'groupId': 'OG004', 'lowerLimit': '36', 'upperLimit': '72'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '46.2', 'groupId': 'OG006', 'lowerLimit': '33', 'upperLimit': '55'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.49', 'spread': '18', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '55', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '28', 'groupId': 'OG002'}, {'value': '40.9', 'spread': '50', 'groupId': 'OG003'}, {'value': '17.9', 'spread': '55', 'groupId': 'OG004'}, {'value': '19.4', 'spread': '69', 'groupId': 'OG005'}, {'value': '13.6', 'spread': '23', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '57', 'groupId': 'OG000'}, {'value': '2.44', 'spread': '60', 'groupId': 'OG001'}, {'value': '1.46', 'spread': '30', 'groupId': 'OG002'}, {'value': '1.11', 'spread': '67', 'groupId': 'OG003'}, {'value': '1.52', 'spread': '120', 'groupId': 'OG004'}, {'value': '1.75', 'spread': '40', 'groupId': 'OG005'}, {'value': '1.84', 'spread': '8.1', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG006', 'lowerLimit': '0.5', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '547', 'spread': '80', 'groupId': 'OG000'}, {'value': '408', 'spread': '190', 'groupId': 'OG001'}, {'value': '390', 'spread': '76', 'groupId': 'OG002'}, {'value': '367', 'spread': '61', 'groupId': 'OG003'}, {'value': '832', 'spread': '35', 'groupId': 'OG004'}, {'value': '619', 'spread': '110', 'groupId': 'OG005'}, {'value': '514', 'spread': '81', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6900', 'spread': '62', 'groupId': 'OG000'}, {'value': '4900', 'spread': '170', 'groupId': 'OG001'}, {'value': '3670', 'spread': '72', 'groupId': 'OG002'}, {'value': '4280', 'spread': '48', 'groupId': 'OG003'}, {'value': '8440', 'spread': '32', 'groupId': 'OG004'}, {'value': '5650', 'spread': '88', 'groupId': 'OG005'}, {'value': '6680', 'spread': '53', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '3.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '6.0'}, {'value': '3.00', 'groupId': 'OG006', 'lowerLimit': '2.0', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '809', 'spread': '41', 'groupId': 'OG000'}, {'value': '709', 'spread': '71', 'groupId': 'OG001'}, {'value': '597', 'spread': '38', 'groupId': 'OG002'}, {'value': '579', 'spread': '100', 'groupId': 'OG003'}, {'value': '833', 'spread': '49', 'groupId': 'OG004'}, {'value': '743', 'spread': '53', 'groupId': 'OG005'}, {'value': '646', 'spread': '24', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '11300', 'spread': '21', 'groupId': 'OG000'}, {'value': '7680', 'spread': '88', 'groupId': 'OG001'}, {'value': '6990', 'spread': '38', 'groupId': 'OG002'}, {'value': '6120', 'spread': '110', 'groupId': 'OG003'}, {'value': '12100', 'spread': '58', 'groupId': 'OG004'}, {'value': '8140', 'spread': '58', 'groupId': 'OG005'}, {'value': '10100', 'spread': '44', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 't1/2 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '34.9', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '44'}, {'value': '36.5', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '38.4', 'groupId': 'OG004', 'lowerLimit': '27', 'upperLimit': '52'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '21', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '88', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '38', 'groupId': 'OG002'}, {'value': '29.4', 'spread': '110', 'groupId': 'OG003'}, {'value': '20.3', 'spread': '58', 'groupId': 'OG004'}, {'value': '22.1', 'spread': '58', 'groupId': 'OG005'}, {'value': '24.2', 'spread': '44', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '40', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '45', 'groupId': 'OG001'}, {'value': '1.89', 'spread': '110', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '55', 'groupId': 'OG003'}, {'value': '1.56', 'spread': '42', 'groupId': 'OG004'}, {'value': '1.60', 'spread': '100', 'groupId': 'OG005'}, {'value': '1.46', 'spread': '100', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '160', 'groupId': 'OG000'}, {'value': '123', 'spread': '56', 'groupId': 'OG001'}, {'value': '45.6', 'spread': '110', 'groupId': 'OG002'}, {'value': '77.8', 'spread': '110', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '855', 'spread': '150', 'groupId': 'OG000'}, {'value': '1750', 'spread': '77', 'groupId': 'OG001'}, {'value': '699', 'spread': '72', 'groupId': 'OG002'}, {'value': '2460', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6.0'}, {'value': '6.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '174', 'spread': '50', 'groupId': 'OG000'}, {'value': '232', 'spread': '120', 'groupId': 'OG001'}, {'value': '158', 'spread': '73', 'groupId': 'OG002'}, {'value': '245', 'spread': '45', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3270', 'spread': '64', 'groupId': 'OG000'}, {'value': '4320', 'spread': '150', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG002'}, {'value': '4190', 'spread': '52', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '64', 'groupId': 'OG000'}, {'value': '9.26', 'spread': '150', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG002'}, {'value': '14.3', 'spread': '52', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.82', 'spread': '60', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '46', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '57', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '527', 'spread': '67', 'groupId': 'OG000'}, {'value': '609', 'spread': '27', 'groupId': 'OG001'}, {'value': '168', 'spread': '130', 'groupId': 'OG002'}, {'value': '363', 'spread': '64', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '5380', 'spread': '50', 'groupId': 'OG000'}, {'value': '6540', 'spread': '20', 'groupId': 'OG001'}, {'value': '2260', 'spread': '70', 'groupId': 'OG002'}, {'value': '4160', 'spread': '77', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '5.00', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '508', 'spread': '10', 'groupId': 'OG000'}, {'value': '1010', 'spread': '27', 'groupId': 'OG001'}, {'value': '227', 'spread': '19', 'groupId': 'OG002'}, {'value': '408', 'spread': '62', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '7000', 'spread': '12', 'groupId': 'OG000'}, {'value': '13500', 'spread': '39', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG002'}, {'value': '5410', 'spread': '57', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '12', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '39', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG002'}, {'value': '33.3', 'spread': '57', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '40', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '19', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG002'}, {'value': '1.36', 'spread': '57', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '38', 'groupId': 'OG000'}, {'value': '90.7', 'spread': '87', 'groupId': 'OG001'}, {'value': '116', 'spread': '63', 'groupId': 'OG002'}, {'value': '48.2', 'spread': '97', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2 All Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1080', 'spread': '26', 'groupId': 'OG000'}, {'value': '1330', 'spread': '100', 'groupId': 'OG001'}, {'value': '1790', 'spread': '73', 'groupId': 'OG002'}, {'value': '700', 'spread': '84', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'spread': '62', 'groupId': 'OG000'}, {'value': '237', 'spread': '63', 'groupId': 'OG001'}, {'value': '254', 'spread': '120', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2200', 'spread': '57', 'groupId': 'OG000'}, {'value': '4570', 'spread': '68', 'groupId': 'OG001'}, {'value': '4700', 'spread': '120', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 't1/2 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '45'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '83'}, {'value': '36.0', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '44'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'spread': '57', 'groupId': 'OG000'}, {'value': '8.76', 'spread': '68', 'groupId': 'OG001'}, {'value': '8.52', 'spread': '120', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.92', 'spread': '51', 'groupId': 'OG000'}, {'value': '3.28', 'spread': '52', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '63', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '298', 'spread': '52', 'groupId': 'OG000'}, {'value': '355', 'spread': '55', 'groupId': 'OG001'}, {'value': '315', 'spread': '58', 'groupId': 'OG002'}, {'value': '253', 'spread': '90', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3010', 'spread': '37', 'groupId': 'OG000'}, {'value': '3800', 'spread': '63', 'groupId': 'OG001'}, {'value': '3210', 'spread': '59', 'groupId': 'OG002'}, {'value': '3340', 'spread': '78', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '231', 'spread': '63', 'groupId': 'OG000'}, {'value': '362', 'spread': '60', 'groupId': 'OG001'}, {'value': '369', 'spread': '66', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3390', 'spread': '39', 'groupId': 'OG000'}, {'value': '5250', 'spread': '66', 'groupId': 'OG001'}, {'value': '4580', 'spread': '56', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 't1/2 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '33'}, {'value': '26.6', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '37'}, {'value': '30.9', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '39', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '66', 'groupId': 'OG001'}, {'value': '21.8', 'spread': '56', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'spread': '40', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '58', 'groupId': 'OG001'}, {'value': '1.43', 'spread': '57', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '24.0'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '487', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '334', 'spread': '44', 'groupId': 'OG001'}, {'value': '256', 'spread': '130', 'groupId': 'OG002'}, {'value': '277', 'spread': '110', 'groupId': 'OG003'}, {'value': '408', 'spread': '89', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6560', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '5210', 'spread': '43', 'groupId': 'OG001'}, {'value': '4470', 'spread': '120', 'groupId': 'OG002'}, {'value': '4090', 'spread': '120', 'groupId': 'OG003'}, {'value': '5630', 'spread': '90', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as median.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '587', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '502', 'spread': '16', 'groupId': 'OG001'}, {'value': '469', 'spread': '40', 'groupId': 'OG002'}, {'value': '393', 'spread': '44', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '9560', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '7920', 'spread': '16', 'groupId': 'OG001'}, {'value': '7390', 'spread': '32', 'groupId': 'OG002'}, {'value': '5790', 'spread': '46', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 't1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '38.6', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '42'}, {'value': '50.2', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': '89'}, {'value': '42.6', 'groupId': 'OG003', 'lowerLimit': '27', 'upperLimit': '64'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '16', 'groupId': 'OG001'}, {'value': '16.9', 'spread': '32', 'groupId': 'OG002'}, {'value': '21.6', 'spread': '46', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '51', 'groupId': 'OG001'}, {'value': '1.89', 'spread': '94', 'groupId': 'OG002'}, {'value': '1.72', 'spread': '83', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '24'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '714', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '265', 'spread': '140', 'groupId': 'OG001'}, {'value': '289', 'spread': '100', 'groupId': 'OG002'}, {'value': '393', 'spread': '90', 'groupId': 'OG003'}, {'value': '369', 'spread': '35', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '8050', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '3380', 'spread': '100', 'groupId': 'OG001'}, {'value': '3310', 'spread': '76', 'groupId': 'OG002'}, {'value': '4030', 'spread': '88', 'groupId': 'OG003'}, {'value': '4500', 'spread': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Tmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '24'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '6.0'}, {'value': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Cmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '412', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '518', 'spread': '67', 'groupId': 'OG001'}, {'value': '520', 'spread': '84', 'groupId': 'OG002'}, {'value': '334', 'spread': '83', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6300', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '6310', 'spread': '31', 'groupId': 'OG001'}, {'value': '5930', 'spread': '73', 'groupId': 'OG002'}, {'value': '3990', 'spread': '74', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 't1/2 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '66'}, {'value': '58.2', 'groupId': 'OG002', 'lowerLimit': '40', 'upperLimit': '83'}, {'value': '37.8', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '50'}, {'value': '30.3', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'CL/F of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '31', 'groupId': 'OG001'}, {'value': '30.3', 'spread': '73', 'groupId': 'OG002'}, {'value': '45.1', 'spread': '74', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG004', 'title': 'S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': 'NA', 'comment': 'Measure dispersion not applicable as only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '110', 'groupId': 'OG001'}, {'value': '1.90', 'spread': '50', 'groupId': 'OG002'}, {'value': '1.03', 'spread': '84', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned, summary statistics were not derived if fewer than 3 participants had available data.', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Best Overall Response - Dose Escalation Stages 1, 1A and 1B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '35', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG007', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG008', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG009', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG010', 'title': 'S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.'}, {'id': 'OG011', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG012', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG013', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG014', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG015', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG016', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG017', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'classes': [{'title': 'PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '16', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '17', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}]}]}, {'title': 'Unable to Evaluate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)', 'description': 'Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) = disappearance of all target and non-target lesions. Partial Response (PR) = at least 30 percent (%) decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment start.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response - Dose Escalation Stages 1, 1A and 1B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG007', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG008', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG009', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG010', 'title': 'S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.'}, {'id': 'OG011', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG012', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG013', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG014', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG015', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG016', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG017', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'timeFrame': 'Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)', 'description': 'Duration of objective response was defined as the time from first occurrence of a documented objective response (CR or PR) until the time of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). CR = disappearance of all target and non-target lesions. PR = at least 30 % decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected as per changes in planned analysis.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) - Dose Escalation Stages 1, 1A and 1B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}]}], 'groups': [{'id': 'OG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG003', 'title': 'S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.'}, {'id': 'OG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG007', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG008', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG009', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG010', 'title': 'S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.'}, {'id': 'OG011', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG012', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG013', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG014', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG015', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG016', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'OG017', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'timeFrame': 'Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)', 'description': 'PFS was the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not collected as per changes in planned analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Stage 1 Cohort 1 (S1 C1): Participants received a single oral dose of pictilisib 80 milligrams (mg) capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG001', 'title': 'S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Stage 1 Cohort 2 (S1 C2): Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG002', 'title': 'S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib', 'description': 'Stage 1 Cohort 3 (S1 C3): Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG003', 'title': 'S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Stage 1 Cohort 4 (S1 C4): Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG004', 'title': 'S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Stage 1 Cohort 5 (S1 C5): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG005', 'title': 'S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Stage 1 Cohort 6 (S1 C6): Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG006', 'title': 'S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Stage 1 Cohort 6A (S1 C6A): Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG007', 'title': 'S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Stage 1A Cohort A (S1A CA): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG008', 'title': 'S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Stage 1A Cohort B (S1A CB): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG009', 'title': 'S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Stage 1A Cohort C (S1A CC): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG010', 'title': 'S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Stage 1A Cohort D (S1A CD): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG011', 'title': 'S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Stage 1A Cohort E (S1A CE): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG012', 'title': 'S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Stage 1A Cohort F (S1A CF): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG013', 'title': 'S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib', 'description': 'Stage 1A Cohort G (S1A CG): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG014', 'title': 'S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Stage 1B Cohort AX (S1B CAX): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG015', 'title': 'S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Stage 1B Cohort BX (S1B CBX): Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG016', 'title': 'S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib', 'description': 'Stage 1B Cohort CX (S1B CCX): Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG017', 'title': 'S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Stage 1B Cohort DX (S1B CDX): Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}, {'id': 'FG018', 'title': 'S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib', 'description': 'Stage 2 (S2) expansion cohort: Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non-small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).'}, {'id': 'FG019', 'title': 'S2A Expansion: 125 mg Cobimetinib + 180 mg Pictilisib', 'description': 'Stage 2A (S2A) expansion cohort: Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.'}], 'periods': [{'title': 'Dose-Escalation Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}]}, {'title': 'Dose-Escalation Stage 1A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '9'}, {'groupId': 'FG012', 'numSubjects': '8'}, {'groupId': 'FG013', 'numSubjects': '5'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '9'}, {'groupId': 'FG012', 'numSubjects': '8'}, {'groupId': 'FG013', 'numSubjects': '5'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, 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{'groupId': 'FG019', 'numSubjects': '0'}]}]}, {'title': 'Expansion Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '35'}, {'groupId': 'FG019', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 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{'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 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{'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '31'}]}]}], 'preAssignmentDetails': 'Study was terminated before initiation of Stage 2B; hence Stage 2B cohorts were not applicable.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants who received cobimetinib and pictilisib in any dose combination until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '12.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'whyStopped': 'A recommended Phase 2 dose and schedule was not identified and the study was terminated before initiation of Stage 2B.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-04', 'studyFirstSubmitDate': '2009-10-12', 'resultsFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-04', 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-Limiting Toxicities (DLTs) During Dose Escalation Stages 1, 1A and 1B', 'timeFrame': 'Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28', 'description': 'DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non clinically significant (as assessed by Investigator) laboratory abnormality that was asymptomatic; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count \\<500/microliter) lasting \\>5 days; Grade ≥4 thrombocytopenia lasting \\>48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting \\>72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.'}, {'measure': 'Maximum Tolerated Combination Doses of Cobimetinib and Pictilisib During Dose-Escalation Stages 1, 1A and 1B', 'timeFrame': 'Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28', 'description': 'MTD was determined (by Investigator) based on the DLTs, as well as adverse events (AEs) in dose-escalation Stages 1, 1A, and 1B that did not meet protocol-defined DLT criteria but indicated intolerability of a given dose combination. Separate combination MTDs were determined for each dose-escalation stage. DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non-hepatic organ toxicity; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count \\<500/microliter) lasting \\>5 days; Grade ≥4 thrombocytopenia lasting \\>48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting \\>72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.'}, {'measure': 'Time of Maximum Concentration (Tmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3', 'timeFrame': '0-4 hours pre-cobimetinib (Pr-C) dose, 0.5, 2, 4, 6 hours post-cobimetinib (Po-C) dose on Day 3, Day 4'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3', 'timeFrame': '0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to 24 Hours Post-Dose (AUC0-24) of Cobimetinib on Day 3 - Stage 1, Cohorts 1-3', 'timeFrame': '0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4'}, {'measure': 'Tmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3', 'timeFrame': '0-4 hours pre-pictilisib (Pr-P) dose, 0.5, 2, 4, 6 hours post-pictilisib (Po-P) dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3'}, {'measure': 'Cmax of Pictilisib on Day 1 - Stage 1, Cohorts 1-3', 'timeFrame': '0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3'}, {'measure': 'AUC0-24 of Pictilisib on Day 1 - Stage 1, Cohorts 1-3', 'timeFrame': '0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3'}], 'secondaryOutcomes': [{'measure': 'Tmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22'}, {'measure': 'Terminal Half-life (t1/2) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Apparent Clearance (CL/F) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2, 22', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22'}, {'measure': 't1/2 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'CL/F of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) - Stage 1 All Cohorts', 'timeFrame': 'Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Day 2, 22', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19'}, {'measure': 't1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19'}, {'measure': 't1/2 of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'CL/F of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 1A All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22'}, {'measure': 'CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 1B All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22'}, {'measure': 'CL/F of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 1B All Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22', 'description': 'Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2 All Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 't1/2 of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'CL/F of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately.'}, {'measure': 't1/2 of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'CL/F of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 21 - Stage 2 Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22', 'description': 'Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.'}, {'measure': 'Tmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as median.'}, {'measure': 'Cmax of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'AUC0-24 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 't1/2 of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'CL/F of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 1 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately.'}, {'measure': 'Tmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'Cmax of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'AUC0-24 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 't1/2 of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'CL/F of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'Accumulation Ratio of Pictilisib on Cycle 1 Day 18 - Stage 2A Individual Indication Specific Cohorts', 'timeFrame': 'Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21', 'description': 'Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.'}, {'measure': 'Number of Participants With Best Overall Response - Dose Escalation Stages 1, 1A and 1B', 'timeFrame': 'Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)', 'description': 'Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) = disappearance of all target and non-target lesions. Partial Response (PR) = at least 30 percent (%) decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment start.'}, {'measure': 'Duration of Objective Response - Dose Escalation Stages 1, 1A and 1B', 'timeFrame': 'Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)', 'description': 'Duration of objective response was defined as the time from first occurrence of a documented objective response (CR or PR) until the time of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). CR = disappearance of all target and non-target lesions. PR = at least 30 % decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.'}, {'measure': 'Progression-Free Survival (PFS) - Dose Escalation Stages 1, 1A and 1B', 'timeFrame': 'Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)', 'description': 'PFS was the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.'}]}, 'conditionsModule': {'keywords': ['GDC0941', 'GDC0973', 'MEK', 'MEK Inhibitor', 'PI3K', 'PI3K Inhibitor', 'PI3 Kinase', 'PI3 Kinase Inhibitor'], 'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib administered in combination in patients with locally advanced or metastatic solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable\n* Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)\n* Life expectancy greater than or equal to (\\>=) 12 weeks\n* Adequate hematologic and end organ function\n* Agreement to use an effective form of contraception for the duration of the study\n\nExclusion Criteria:\n\n* History of prior significant toxicity from another mitogen-activated protein kinase (MEK) pathway inhibitor requiring discontinuation of treatment\n* History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) pathway inhibitor requiring discontinuation of treatment\n* Allergy or hypersensitivity to components of the cobimetinib or pictilisib formulations\n* Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1\n* Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1\n* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment\n* Prior anti-cancer therapy within 28 days before the first dose of study drug treatment in Cycle 1\n* History of diabetes requiring daily medication, or history of Grade \\>= 3 fasting hyperglycemia\n* Current severe, uncontrolled systemic disease\n* History of clinically significant cardiac or pulmonary dysfunction\n* History of malabsorption or other condition that would interfere with enteral absorption\n* Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus\n* Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics\n* Active autoimmune disease\n* Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment\n* Pregnancy, lactation, or breastfeeding\n* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms\n* No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays'}, 'identificationModule': {'nctId': 'NCT00996892', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase Ib, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0973 in Combination With GDC-0941 When Administered in Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'MEK4752g'}, 'secondaryIdInfos': [{'id': 'GO01330', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Stage 1: Cobimetinib + Pictilisib', 'description': 'Participants will receive cobimetinib capsules (at a starting dose of 20 milligrams \\[mg\\]) and pictilisib capsules (at a starting dose of 80 mg) from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Doses will be increased to identify maximum tolerated dose (MTD) or potential recommended Phase 2 dose (RP2D). Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: Pictilisib']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Stage 1A: Cobimetinib + Pictilisib', 'description': 'Participants will receive cobimetinib capsules (at a starting dose of 100 mg) on Days 1, 4, 8, 11, 15, and 18 and pictilisib capsules (at a starting dose of 130 mg) from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Doses will be increased to identify MTD or potential RP2D.Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: Pictilisib']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Stage 1B: Cobimetinib + Pictilisib', 'description': 'Participants will receive cobimetinib capsules (at a starting dose of 40 mg) and pictilisib capsules (at a starting dose of 130 mg) from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants will be off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: Pictilisib']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Stage 2: Cobimetinib + Pictilisib', 'description': 'Participants will received cobimetinib capsules and pictilisib capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles, at doses identified as MTD/potential RP2D from Stage 1. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. This indication specific cohort will include participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non-small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).', 'interventionNames': ['Drug: Cobimetinib', 'Drug: Pictilisib']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Stage 2A: Cobimetinib + Pictilisib', 'description': 'Participants received cobimetinib capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles, at doses identified as MTD/potential RP2D from Stage 1A. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. This indication specific cohort will include participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: Pictilisib']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Stage 2B: Cobimetinib + Pictilisib', 'description': 'Participants will receive cobimetinib capsules and pictilisib capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles, at doses identified as MTD/potential RP2D from Stage 1B. Participants will be off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment will continue until disease progression, unacceptable toxicity, or any other discontinuation criterion meets. This indication specific cohort will include participants with KRAS mutant endometrioid carcinoma.', 'interventionNames': ['Drug: Cobimetinib', 'Drug: Pictilisib']}], 'interventions': [{'name': 'Cobimetinib', 'type': 'DRUG', 'otherNames': ['GDC-0973', 'XL518'], 'description': 'Repeated oral dosing.', 'armGroupLabels': ['Dose Escalation Stage 1: Cobimetinib + Pictilisib', 'Dose Escalation Stage 1A: Cobimetinib + Pictilisib', 'Dose Escalation Stage 1B: Cobimetinib + Pictilisib', 'Dose Expansion Stage 2: Cobimetinib + Pictilisib', 'Dose Expansion Stage 2A: Cobimetinib + Pictilisib', 'Dose Expansion Stage 2B: Cobimetinib + Pictilisib']}, {'name': 'Pictilisib', 'type': 'DRUG', 'otherNames': ['GDC-0941'], 'description': 'Repeated oral dosing.', 'armGroupLabels': ['Dose Escalation Stage 1: Cobimetinib + Pictilisib', 'Dose Escalation Stage 1A: Cobimetinib + Pictilisib', 'Dose Escalation Stage 1B: Cobimetinib + Pictilisib', 'Dose Expansion Stage 2: Cobimetinib + Pictilisib', 'Dose Expansion Stage 2A: Cobimetinib + Pictilisib', 'Dose Expansion Stage 2B: Cobimetinib + Pictilisib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Iris Chan, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}