Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2026-01-01 @ 10:39 PM
Study NCT ID:
NCT01347866
Status:
TERMINATED
Last Update Posted:
2018-10-29
First Post:
2011-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549060', 'term': 'gedatolisib'}, {'id': 'C506614', 'term': 'mirdametinib'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated prematurely for strategic reasons based on an internal portfolio prioritization.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.', 'otherNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'seriousNumAffected': 5}, {'id': 'EG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'PF-05212384+PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 4}, {'id': 'EG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG014', 'title': 'PF-05212384+ PD-0325901: Arm D1B (Stage 1))', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'PF-05212384+ PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 17}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 19}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 14}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 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'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '50.0', 'groupId': 'OG007'}, {'value': '14.3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '14.3', 'groupId': 'OG011'}, {'value': '14.3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days', 'description': 'DLT was defined as any of the following hematologic or non-hematologic events which were attributable to the combination study drug and occurring in the first 28-day cycle: 1) Grade 4 neutropenia lasting greater than (\\>)7 days; 2) Febrile neutropenia (defined as neutropenia greater than or equal to \\[≥\\]Grade 3 and a body temperature ≥38.5°C); 3) Grade ≥3 neutropenic infection; 4) Grade 3 thrombocytopenia with bleeding; 5) Grade 4 thrombocytopenia; 6) Grade ≥3 toxicities; 7) Persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses during the first cycle; 8) Persistent, intolerable toxicities which resulted in delay of start of Cycle 2 by more than 2 weeks of scheduled day; 9) Persistent Grade 3 QTc prolongation (QTc \\>500 msec) after correction of any reversible causes.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment and who did not have a major pre-specified treatment deviation in the first cycle of treatment in Stage 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Any AEs, Grade 1', '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': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '7', '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': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Any AEs, Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Any AEs, Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Any AEs, Grade 4', 'categories': [{'measurements': [{'value': '1', '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': '1', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Any AEs, Grade 5', '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': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Any AEs, Missing or Unknown', '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': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Any AEs, Total', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded by the NCI CTCAE (Version 4.0).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities (Hematology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'Hemoglobin Increased', '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': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Lymphocyte Count Increased', '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': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Absolute Neutrophils', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'White Blood Cells', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities. Hematological tests included platelet count, hemoglobin, and white blood cell (WBC) count with 5- part differential.', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities (Coagulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 coagulation test abnormalities. Coagulation tests included partial thromboplastin time (PTT) and prothrombin time (PT) international normalized ratio (INR).', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment. N=number of evaluable participants for each parameter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities (Chemistry)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'ALT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'Total bilirubin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'creatinine', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'hypercalcemia', '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': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'hyperglycemia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'hyperkalemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', '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'}]}]}, {'title': 'hypermagnesemia', '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': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'hypernatremia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', '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': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'hypoalbuminemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'hypocalcemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'hypokalemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'hypomagnesemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'hyponatremia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'hypophosphatemia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry test abnormalities. Chemistry tests included aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]), serum creatinine, total bilirubin, direct/indirect bilirubin, alkaline phosphatase, chloride, uric acid, phosphorus, calcium, magnesium, potassium, sodium, blood urea nitrogen (BUN) or urea, total protein, albumin, glucose, and insulin.', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities (Urinalysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 urinalysis test abnormalities for urine protein.', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment. Number of participants analyzed=number of evaluable participants for each laboratory parameter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Values Meeting Prespecified Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)', 'categories': [{'measurements': [{'value': '1', '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': '4', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)', 'categories': [{'measurements': [{'value': '1', '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': '1', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)', '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': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)', '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': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', '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'}]}]}, {'title': 'Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)', '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': '1', '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'}]}]}, {'title': 'Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)', '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': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with vital signs values meeting prespecified criteria. Criteria defined as: 1) absolute systolic blood pressue (SBP) less than or equal to (\\<=) 100 millimeter of mercury (mmHg); 2) absolute SBP greater than or equal to (\\>=) 160 mmHg, 3) SBP maximum increase of \\>=20 mmHg from baseline; 4) SBP maximum increase of \\>=40 mmHg from baseline; 5) SBP maximum increase of \\>=60 mmHg from baseline; 6) absolute diastolic blood pressure (DBP) \\<=60 mmHg; 7) absolute DBP \\>=100 mmHg; 8) DBP maximum increase of \\>=10 mmHg from baseline; 9) DBP maximum increase of \\>=20 mmHg from baseline; 10) DBP maximum increase of \\>=30 mmHg from baseline; 11) absolute heart rate (HR) \\<50 beats per minute (bpm); 12) absolute HR \\>120 bpm.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment. N=number of participants evaluated against criteria.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG002', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG003', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}], 'classes': [{'title': 'Cycle 1 Day 2 (N=2, 6, 4, 30)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 1640 and 3050 ng/mL, respectively.', 'groupId': 'OG000'}, {'value': '3404', 'spread': '82', 'groupId': 'OG001'}, {'value': '4759', 'spread': '25', 'groupId': 'OG002'}, {'value': '5221', 'spread': '61', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 16 (N=3, 6, 4, 28)', 'categories': [{'measurements': [{'value': '2201', 'spread': '16', 'groupId': 'OG000'}, {'value': '2814', 'spread': '50', 'groupId': 'OG001'}, {'value': '4656', 'spread': '32', 'groupId': 'OG002'}, {'value': '5728', 'spread': '56', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'nanogram (ng)/milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG004', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG005', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG006', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2)', 'categories': [{'measurements': [{'value': '3625', 'spread': '62', 'groupId': 'OG000'}, {'value': '5937', 'spread': '32', 'groupId': 'OG001'}, {'value': '11170', 'spread': '16', 'groupId': 'OG002'}, {'value': '8476', 'spread': '32', 'groupId': 'OG003'}, {'value': '8586', 'spread': '36', 'groupId': 'OG004'}, {'value': '6279', 'spread': '70', 'groupId': 'OG005'}, {'value': '7239', 'spread': '39', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 9250 and 15200 ng/mL, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1)', 'categories': [{'measurements': [{'value': '8621', 'spread': '18', 'groupId': 'OG000'}, {'value': '6153', 'spread': '34', 'groupId': 'OG001'}, {'value': '12440', 'spread': '32', 'groupId': 'OG002'}, {'value': '8717', 'spread': '50', 'groupId': 'OG003'}, {'value': '8913', 'spread': '54', 'groupId': 'OG004'}, {'value': '9280', 'spread': 'NA', 'comment': 'Individual value is reported. For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.', 'groupId': 'OG005'}, {'value': '7989', 'spread': '45', 'groupId': 'OG006'}, {'value': '15400', 'spread': 'NA', 'comment': 'Individual value is reported. For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG004', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG005', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG006', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2)', 'categories': [{'measurements': [{'value': '85.28', 'spread': '27', 'groupId': 'OG000'}, {'value': '63.80', 'spread': '14', 'groupId': 'OG001'}, {'value': '87.99', 'spread': '51', 'groupId': 'OG002'}, {'value': '180.6', 'spread': '28', 'groupId': 'OG003'}, {'value': '191.9', 'spread': '44', 'groupId': 'OG004'}, {'value': '115.8', 'spread': '70', 'groupId': 'OG005'}, {'value': '231.3', 'spread': '69', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 204 and 372 ng/mL, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2)', 'categories': [{'measurements': [{'value': '91.69', 'spread': '31', 'groupId': 'OG000'}, {'value': '74.23', 'spread': '43', 'groupId': 'OG001'}, {'value': '64.99', 'spread': '56', 'groupId': 'OG002'}, {'value': '138.7', 'spread': '23', 'groupId': 'OG003'}, {'value': '183.6', 'spread': '29', 'groupId': 'OG004'}, {'value': '114.6', 'spread': '50', 'groupId': 'OG005'}, {'value': '211.9', 'spread': '44', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 247 and 428 ng/mL, respectively.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -7 (N=5, 1, 1)', 'categories': [{'measurements': [{'value': '304.9', 'spread': '49', 'groupId': 'OG000'}, {'value': '280', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '101', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1 Day 12 (N=4, 1, 1)', 'categories': [{'measurements': [{'value': '341.9', 'spread': '21', 'groupId': 'OG000'}, {'value': '690', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '182', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -7 (N=5, 1, 1)', 'categories': [{'measurements': [{'value': '38.02', 'spread': '28', 'groupId': 'OG000'}, {'value': '59.8', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '48.7', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1 Day 12 (N=4, 1, 1)', 'categories': [{'measurements': [{'value': '52.02', 'spread': '13', 'groupId': 'OG000'}, {'value': '21.2', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '64.7', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}], 'classes': [{'title': 'Cycle 0 Day -7 (N=7, 7)', 'categories': [{'measurements': [{'value': '41.44', 'spread': '8.1201', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '68.41', 'spread': '31.818', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4.13'}]}]}, {'title': 'Cycle 1 Day 12 (N=7, 5)', 'categories': [{'measurements': [{'value': '46.81', 'spread': '19.381', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '87.30', 'spread': '37.647', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG002', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG003', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}], 'classes': [{'title': 'Cycle 1 Day 2 (N=2, 6, 4, 30)', 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.60'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '1.67'}, {'value': '0.992', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '0.500', 'groupId': 'OG003', 'lowerLimit': '0.467', 'upperLimit': '1.07'}]}]}, {'title': 'Cycle 1 Day 16 (N=3, 6, 4, 28)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.08'}, {'value': '0.992', 'groupId': 'OG001', 'lowerLimit': '0.583', 'upperLimit': '1.05'}, {'value': '0.734', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '0.525', 'groupId': 'OG003', 'lowerLimit': '0.333', 'upperLimit': '2.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG004', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG005', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG006', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2)', 'categories': [{'measurements': [{'value': '0.500', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '0.500', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '0.983'}, {'value': '0.500', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '0.500'}, {'value': '0.500', 'groupId': 'OG003', 'lowerLimit': '0.500', 'upperLimit': '3.22'}, {'value': '0.509', 'groupId': 'OG004', 'lowerLimit': '0.500', 'upperLimit': '0.583'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '0.500', 'upperLimit': '3.08'}, {'value': '0.500', 'groupId': 'OG006', 'lowerLimit': '0.500', 'upperLimit': '0.600'}, {'value': '0.500', 'groupId': 'OG007', 'lowerLimit': '0.500', 'upperLimit': '0.500'}]}]}, {'title': 'Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1)', 'categories': [{'measurements': [{'value': '0.500', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '0.500'}, {'value': '0.500', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '0.500', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '0.517'}, {'value': '0.509', 'groupId': 'OG003', 'lowerLimit': '0.500', 'upperLimit': '0.567'}, {'value': '0.517', 'groupId': 'OG004', 'lowerLimit': '0.500', 'upperLimit': '0.583'}, {'value': '0.667', 'groupId': 'OG005', 'lowerLimit': '0.667', 'upperLimit': '0.667'}, {'value': '0.500', 'groupId': 'OG006', 'lowerLimit': '0.500', 'upperLimit': '3.92'}, {'value': '0.500', 'groupId': 'OG007', 'lowerLimit': '0.500', 'upperLimit': '0.500'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG004', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG005', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG006', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.02'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '3.00'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.33'}, {'value': '1.97', 'groupId': 'OG003', 'lowerLimit': '0.917', 'upperLimit': '4.00'}, {'value': '1.07', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '0.333', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.50', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}, {'title': 'Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '2.02'}, {'value': '2.00', 'groupId': 'OG005', 'lowerLimit': '2.00', 'upperLimit': '4.05'}, {'value': '1.50', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '1.00', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -7 (N=5, 1, 1)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '2.00'}, {'value': '1.92', 'groupId': 'OG002', 'lowerLimit': '1.92', 'upperLimit': '1.92'}]}]}, {'title': 'Cycle 1 Day 12 (N=4, 1, 1)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.02'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -7 (N=5, 1, 1)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.90', 'groupId': 'OG002', 'lowerLimit': '1.90', 'upperLimit': '1.90'}]}]}, {'title': 'Cycle 1 Day 12 (N=4, 1, 1)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '2.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}], 'classes': [{'title': 'Cycle 0 Day -7 (N=7, 7)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4.13'}]}]}, {'title': 'Cycle 1 Day 12 (N=7, 5)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.03', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG002', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG003', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}], 'classes': [{'title': 'Cycle 1 Day 2 (N=1, 5, 3, 25)', 'categories': [{'measurements': [{'value': '24.5', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG000'}, {'value': '32.14', 'spread': '1.3334', 'groupId': 'OG001'}, {'value': '29.23', 'spread': '7.1066', 'groupId': 'OG002'}, {'value': '32.16', 'spread': '4.5154', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 16 (N=1, 5, 3, 20)', 'categories': [{'measurements': [{'value': '33.3', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG000'}, {'value': '37.98', 'spread': '5.5603', 'groupId': 'OG001'}, {'value': '34.50', 'spread': '8.4256', 'groupId': 'OG002'}, {'value': '35.10', 'spread': '3.3067', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG004', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG005', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG006', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2)', 'categories': [{'measurements': [{'value': '24.62', 'spread': '3.2306', 'groupId': 'OG000'}, {'value': '27.37', 'spread': '6.4748', 'groupId': 'OG001'}, {'value': '30.77', 'spread': '6.4933', 'groupId': 'OG002'}, {'value': '25.85', 'spread': '4.1530', 'groupId': 'OG003'}, {'value': '29.35', 'spread': '5.5121', 'groupId': 'OG004'}, {'value': '29.63', 'spread': '3.7072', 'groupId': 'OG005'}, {'value': '27.05', 'spread': '4.6651', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 24.6 and 24.8 hr, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1)', 'categories': [{'measurements': [{'value': '35.90', 'spread': '4.8816', 'groupId': 'OG000'}, {'value': '39.30', 'spread': '10.678', 'groupId': 'OG001'}, {'value': '41.25', 'spread': '6.2303', 'groupId': 'OG002'}, {'value': '34.43', 'spread': '8.5383', 'groupId': 'OG003'}, {'value': '40.20', 'spread': '5.8643', 'groupId': 'OG004'}, {'value': '37.0', 'spread': 'NA', 'comment': 'Individual value is reported. For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.', 'groupId': 'OG005'}, {'value': '33.30', 'spread': '0.96437', 'groupId': 'OG006'}, {'value': '37.0', 'spread': 'NA', 'comment': 'Individual value is reported. For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.92', 'spread': '4.2260', 'groupId': 'OG000'}, {'value': '18.3', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '25.7', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest estimated.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -7 (N=5, 1, 1)', 'categories': [{'measurements': [{'value': '9.374', 'spread': '1.3243', 'groupId': 'OG000'}, {'value': '12.4', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '11.5', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 1 Day 12 (N=4, 0, 0)', 'categories': [{'measurements': [{'value': '8.968', 'spread': '1.5366', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'N = 0.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'N = 0.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}], 'classes': [{'title': 'Cycle 0 Day -7 (N=6, 7)', 'categories': [{'measurements': [{'value': '13.13', 'spread': '2.2879', 'groupId': 'OG000'}, {'value': '13.06', 'spread': '2.6589', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 12 (N=3, 1)', 'categories': [{'measurements': [{'value': '8.597', 'spread': '1.2726', 'groupId': 'OG000'}, {'value': '8.97', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG002', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG003', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}], 'classes': [{'title': 'Cycle 1 Day 2 (N=2, 6, 4, 30)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 7410 and 10500 ng\\*hr/mL, respectively.', 'groupId': 'OG000'}, {'value': '7487', 'spread': '41', 'groupId': 'OG001'}, {'value': '10530', 'spread': '44', 'groupId': 'OG002'}, {'value': '9485', 'spread': '43', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 16 (N=3, 6, 4, 28)', 'categories': [{'measurements': [{'value': '8819', 'spread': '71', 'groupId': 'OG000'}, {'value': '8243', 'spread': '25', 'groupId': 'OG001'}, {'value': '11170', 'spread': '53', 'groupId': 'OG002'}, {'value': '10890', 'spread': '38', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG004', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG005', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG006', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2)', 'categories': [{'measurements': [{'value': '7627', 'spread': '46', 'groupId': 'OG000'}, {'value': '10250', 'spread': '21', 'groupId': 'OG001'}, {'value': '14850', 'spread': '31', 'groupId': 'OG002'}, {'value': '12590', 'spread': '27', 'groupId': 'OG003'}, {'value': '14280', 'spread': '24', 'groupId': 'OG004'}, {'value': '13840', 'spread': '47', 'groupId': 'OG005'}, {'value': '9619', 'spread': '22', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 14900 and 18800 ng\\*hr/mL, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1)', 'categories': [{'measurements': [{'value': '12070', 'spread': '36', 'groupId': 'OG000'}, {'value': '12130', 'spread': '1', 'groupId': 'OG001'}, {'value': '19970', 'spread': '25', 'groupId': 'OG002'}, {'value': '13390', 'spread': '21', 'groupId': 'OG003'}, {'value': '21170', 'spread': '36', 'groupId': 'OG004'}, {'value': '15200', 'spread': 'NA', 'comment': 'Individual value is reported. For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.', 'groupId': 'OG005'}, {'value': '12610', 'spread': '25', 'groupId': 'OG006'}, {'value': '20800', 'spread': 'NA', 'comment': 'Individual value is reported. For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '1479', 'spread': '23', 'groupId': 'OG000'}, {'value': '2030', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '941', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '474.5', 'spread': '29', 'groupId': 'OG000'}, {'value': '933', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '688', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '588.4', 'spread': '49', 'groupId': 'OG000'}, {'value': '1001', 'spread': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG002', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG003', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}], 'classes': [{'title': 'Cycle 1 Day 2 (N=1, 5, 3, 25)', 'categories': [{'measurements': [{'value': '7540', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG000'}, {'value': '7968', 'spread': '41', 'groupId': 'OG001'}, {'value': '9277', 'spread': '48', 'groupId': 'OG002'}, {'value': '10070', 'spread': '42', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 Day 16 (N=1, 5, 3, 20)', 'categories': [{'measurements': [{'value': '5870', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG000'}, {'value': '8627', 'spread': '26', 'groupId': 'OG001'}, {'value': '9174', 'spread': '17', 'groupId': 'OG002'}, {'value': '10610', 'spread': '37', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG004', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG005', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG006', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2)', 'categories': [{'measurements': [{'value': '6353', 'spread': '40', 'groupId': 'OG000'}, {'value': '10460', 'spread': '20', 'groupId': 'OG001'}, {'value': '14880', 'spread': '39', 'groupId': 'OG002'}, {'value': '12600', 'spread': '29', 'groupId': 'OG003'}, {'value': '14620', 'spread': '23', 'groupId': 'OG004'}, {'value': '14230', 'spread': '46', 'groupId': 'OG005'}, {'value': '9766', 'spread': '22', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 15100 and 19100 ng\\*hr/mL, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1)', 'categories': [{'measurements': [{'value': '10430', 'spread': '33', 'groupId': 'OG000'}, {'value': '12460', 'spread': '2', 'groupId': 'OG001'}, {'value': '20440', 'spread': '26', 'groupId': 'OG002'}, {'value': '13770', 'spread': '20', 'groupId': 'OG003'}, {'value': '23730', 'spread': '39', 'groupId': 'OG004'}, {'value': '15500', 'spread': 'NA', 'comment': 'Individual value is reported. For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.', 'groupId': 'OG005'}, {'value': '13320', 'spread': '27', 'groupId': 'OG006'}, {'value': '21300', 'spread': 'NA', 'comment': 'Individual value is reported. For arms with \\<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '1599', 'spread': '26', 'groupId': 'OG000'}, {'value': '2140', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '1060', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '523.9', 'spread': '21', 'groupId': 'OG000'}, {'value': '950', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG001'}, {'value': '697', 'spread': 'NA', 'comment': 'Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '705.0', 'spread': '41', 'groupId': 'OG000'}, {'value': '1028', 'spread': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Increase From Baseline in QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Maximum QTcB Interval Increase <30msec', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '28', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'MaximumQTcB Interval Increase >=30to<60msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcB Interval Increase >=60 msec', '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': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcF Interval Increase <30 msec', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}]}, {'title': 'MaximumQTcF Interval Increase >=30 to<60msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcF Interval Increase >=60 msec', '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': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': "Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF) .", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study having at least one ECG assessment after receiving study drug for the respective arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Maximum Post-dose QT Interval Corrected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'Maximum QTcB Interval <450 msec', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcB Interval 450 to <=480 msec', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcB Interval >480 to <=500 msec', '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': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcB Interval >500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', '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': '2', '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': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcF Interval <450 msec', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcF Interval 450 to <=480 msec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcF Interval >480 to <=500 msec', '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': '1', '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': '1', 'groupId': 'OG016'}]}]}, {'title': 'Maximum QTcF Interval >500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', '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': '1', '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': "Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study having at least one ECG assessment after receiving study drug for the respective arm.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '30', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '45.9'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '3.3', 'groupId': 'OG008', 'lowerLimit': '0.1', 'upperLimit': '17.2'}, {'value': '0', 'groupId': 'OG009', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '33.3', 'groupId': 'OG010', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '0', 'groupId': 'OG011', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '28.6', 'groupId': 'OG012', 'lowerLimit': '3.7', 'upperLimit': '71.0'}, {'value': '14.3', 'groupId': 'OG013', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '0', 'groupId': 'OG014', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0', 'groupId': 'OG015', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG016', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.', 'description': 'CR was defined as the disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \\<10 mm). PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment on the assigned arm and had an adequate baseline tumor assessment.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.', 'description': 'Progression-free survival (PFS) was the time from first dose to date of first documentation of progression or death due to any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment on the assigned arm and had an adequate baseline tumor assessment.'}, {'type': 'SECONDARY', 'title': 'Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG002', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG003', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG006', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG008', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.974', 'spread': '0.0864', 'groupId': 'OG000'}, {'value': '1.015', 'spread': '0.1935', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm C1 for Stage 1 had 2 participants with data at End of treatment and were not summarized. The individual values were 1.305 and 1.293.', 'groupId': 'OG002'}, {'value': '1.011', 'spread': '0.1165', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm C3 for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 0.64, 1.262, and 1.093.', 'groupId': 'OG004'}, {'value': '1.111', 'spread': '0.2895', 'groupId': 'OG005'}, {'value': '1.212', 'spread': '0.3284', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D0A for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 0.708 , 0.973 and 1.024.', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D0B for Stage 1 had 2 participants with data at End of treatment and were not summarized. The individual values were 0.956 and 1.104.', 'groupId': 'OG008'}, {'value': '0.966', 'spread': '0.1904', 'groupId': 'OG009'}, {'value': '1.13', 'spread': '0.3886', 'groupId': 'OG010'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D1B for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 1.641,1.198 and 0.947.', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D2 for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were 0.93, 0.74, 1.113 and 0.817.', 'groupId': 'OG012'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D2A for Stage 1 had 1 participants with data at End of treatment and were not summarized. The individual values was 0.783.', 'groupId': 'OG013'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.'}, {'type': 'SECONDARY', 'title': 'Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG001', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG002', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG003', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG006', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG007', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG008', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Arm B1 for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were 0.412, 2.2, 1, 0.973.', 'groupId': 'OG000'}, {'value': '1.628', 'spread': '1.888', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm C1 for Stage 1 had 2 participants with data at End of treatment and were not summarized. The individual values were 1.528 and 1.14.', 'groupId': 'OG002'}, {'value': '2.178', 'spread': '2.3194', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm C3 for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 0.244, 0.769, 0.552.', 'groupId': 'OG004'}, {'value': '1.699', 'spread': '2.0031', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D0 for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were 0.833, 5.143, 0.979, 0.744.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D0A for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 0.374, 0.905, 0.736.', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D0B for Stage 1 had 1 participant with data at End of treatment and was not summarized. The individual value was 1.434.', 'groupId': 'OG008'}, {'value': '2.233', 'spread': '2.3617', 'groupId': 'OG009'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D1A for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were2.026, 0.665, 0.32, 4.404.', 'groupId': 'OG010'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D1B for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 2.116, 1.187, 1.172.', 'groupId': 'OG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D2 for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were 0.403, 0.281, 3.293, 3.776.', 'groupId': 'OG012'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm D2A for Stage 1 had 1 participant with data at End of treatment and was not summarized. The individual value was 0.083.', 'groupId': 'OG013'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.'}, {'type': 'SECONDARY', 'title': 'Ratio to Baseline in Serum Glucose Level at Cycle 2 Day 16 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.965', 'spread': '0.2697', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm A2 for Stage 1 had only 1 participant with data at Cycle 2 Day 16 and was not summarized. The individual value for the 1 participant was 1.035.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.'}, {'type': 'SECONDARY', 'title': 'Ratio to Baseline in Serum Insulin Level at Cycle 2 Day 16 for Arm A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.652', 'spread': '0.3622', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arm A2 for Stage 1 had only 1 participant with data at Cycle 2 Day 16 and was not summarized. The individual value for the 1 participant was 0.972.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'OG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'OG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG015', 'title': 'PF-05212384+PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'OG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'classes': [{'title': 'KRAS mutation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'PTEN tumor manual score', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}, {'title': 'PTEN stroma manual score', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Cycle 1 Day 23.', 'description': 'Number of participants with expression of genes relating to PI3K, MAPK and/or Wnt pathway signaling (kirsten rat sarcoma 2 viral oncogene homolog \\[KRAS\\] and PTEN protein). Biopsies were obtained at baseline and Cycle 1 Day 23. Biomarker evaluation was performed on these biopsies.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who started treatment and had baseline tumor tissues successfully analyzed for at least one of the biomarkers.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (Stage 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}], 'timeFrame': 'Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until until progression of disease was documented.', 'description': 'Duration of response was to be calculated for participants with an objective response. Duration of PR or CR was the time from start date (date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was only 1 participant in Arm C1 and 1 in Arm C2 with a response, therefore summary statistics were not calculated for this endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'FG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'FG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'FG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'FG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'FG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'FG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG012', 'title': 'PF-05212384+PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG014', 'title': 'PF-05212384+PD-0325901: Arm D1B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG015', 'title': 'PF-05212384+ PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'FG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '31'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '7'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '4'}, {'groupId': 'FG016', 'numSubjects': '2'}]}, {'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'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '31'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '7'}, {'groupId': 'FG014', 'numSubjects': '3'}, {'groupId': 'FG015', 'numSubjects': '4'}, {'groupId': 'FG016', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', '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': '1'}, {'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'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '22'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '4'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '3'}, {'groupId': 'FG016', 'numSubjects': '0'}]}, {'type': 'Subject refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '3'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'In Arms A and B, 7 and 14 participants were screed and received study treatment, respectively. In Arm C, 45 participants were screened and 44 received study treatment. In Arm D, 39 participants were screened and 37 received study treatment. There was no Stage 2 for Arm D, the study was terminated before enrolling patients to Stage 2 for Arm D.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '31', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '4', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '102', 'groupId': 'BG017'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04691502+PF-0325901: Arm A1 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG001', 'title': 'PF-04691502+PF 0325901: Arm A2 (Stage1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG002', 'title': 'PF-04691502+PF 0325901: Arm A4 (Stage1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG003', 'title': 'PF-04691502+Irinotecan: Arm B1 (Stage 1)', 'description': 'Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'BG004', 'title': 'PF-04691502+Irinotecan: Arm B2 (Stage 1)', 'description': 'Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'BG005', 'title': 'PF-05212384+Irinotecan: Arm C1 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'BG006', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'BG007', 'title': 'PF-05212384+Irinotecan: Arm C3 (Stage 1)', 'description': 'Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly.'}, {'id': 'BG008', 'title': 'PF-05212384+Irinotecan: Arm C2 (Stage 2)', 'description': 'Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.'}, {'id': 'BG009', 'title': 'PF-05212384+ PD-0325901: Arm D0 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG010', 'title': 'PF-05212384+ PD-0325901: Arm D0A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG011', 'title': 'PF-05212384+ PD-0325901: Arm D0B (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG012', 'title': 'PF-05212384+ PD-0325901: Arm D1 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG013', 'title': 'PF-05212384+ PD-0325901: Arm D1A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG014', 'title': 'PF-05212384+ PD-0325901: Arm D1B (Stage 1))', 'description': 'Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG015', 'title': 'PF-05212384+ PD-0325901: Arm D2 (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG016', 'title': 'PF-05212384+ PD-0325901: Arm D2A (Stage 1)', 'description': 'Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.'}, {'id': 'BG017', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '0.0', 'groupId': 'BG001'}, {'value': '49.0', 'spread': '0.0', 'groupId': 'BG002'}, {'value': '53.6', 'spread': '14.1', 'groupId': 'BG003'}, {'value': '59.1', 'spread': '12.9', 'groupId': 'BG004'}, {'value': '67.0', 'spread': '3.6', 'groupId': 'BG005'}, {'value': '60.8', 'spread': '7.2', 'groupId': 'BG006'}, {'value': '63.3', 'spread': '14.5', 'groupId': 'BG007'}, {'value': '56.7', 'spread': '12.4', 'groupId': 'BG008'}, {'value': '63.3', 'spread': '5.9', 'groupId': 'BG009'}, {'value': '43.3', 'spread': '9.1', 'groupId': 'BG010'}, {'value': '64.0', 'spread': '8.9', 'groupId': 'BG011'}, {'value': '55.7', 'spread': '10.0', 'groupId': 'BG012'}, {'value': '57.9', 'spread': '12.9', 'groupId': 'BG013'}, {'value': '61.3', 'spread': '14.2', 'groupId': 'BG014'}, {'value': '60.0', 'spread': '11.8', 'groupId': 'BG015'}, {'value': '54.5', 'spread': '9.2', 'groupId': 'BG016'}, {'value': '58.5', 'spread': '11.8', 'groupId': 'BG017'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '44', 'groupId': 'BG017'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '5', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG014'}, {'value': '2', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '58', 'groupId': 'BG017'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'whyStopped': 'Refer to Detailed Description for documentaion of Termination Statement.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2011-05-02', 'resultsFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2011-05-03', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-13', 'studyFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days)', 'timeFrame': 'Baseline up to 28 days', 'description': 'DLT was defined as any of the following hematologic or non-hematologic events which were attributable to the combination study drug and occurring in the first 28-day cycle: 1) Grade 4 neutropenia lasting greater than (\\>)7 days; 2) Febrile neutropenia (defined as neutropenia greater than or equal to \\[≥\\]Grade 3 and a body temperature ≥38.5°C); 3) Grade ≥3 neutropenic infection; 4) Grade 3 thrombocytopenia with bleeding; 5) Grade 4 thrombocytopenia; 6) Grade ≥3 toxicities; 7) Persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses during the first cycle; 8) Persistent, intolerable toxicities which resulted in delay of start of Cycle 2 by more than 2 weeks of scheduled day; 9) Persistent Grade 3 QTc prolongation (QTc \\>500 msec) after correction of any reversible causes.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade', 'timeFrame': 'Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded by the NCI CTCAE (Version 4.0).'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities (Hematology)', 'timeFrame': 'Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities. Hematological tests included platelet count, hemoglobin, and white blood cell (WBC) count with 5- part differential.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities (Coagulation)', 'timeFrame': 'Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 coagulation test abnormalities. Coagulation tests included partial thromboplastin time (PTT) and prothrombin time (PT) international normalized ratio (INR).'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities (Chemistry)', 'timeFrame': 'Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry test abnormalities. Chemistry tests included aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]), serum creatinine, total bilirubin, direct/indirect bilirubin, alkaline phosphatase, chloride, uric acid, phosphorus, calcium, magnesium, potassium, sodium, blood urea nitrogen (BUN) or urea, total protein, albumin, glucose, and insulin.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities (Urinalysis)', 'timeFrame': 'Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 urinalysis test abnormalities for urine protein.'}, {'measure': 'Number of Participants With Vital Signs Values Meeting Prespecified Criteria', 'timeFrame': 'Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': 'Number of participants with vital signs values meeting prespecified criteria. Criteria defined as: 1) absolute systolic blood pressue (SBP) less than or equal to (\\<=) 100 millimeter of mercury (mmHg); 2) absolute SBP greater than or equal to (\\>=) 160 mmHg, 3) SBP maximum increase of \\>=20 mmHg from baseline; 4) SBP maximum increase of \\>=40 mmHg from baseline; 5) SBP maximum increase of \\>=60 mmHg from baseline; 6) absolute diastolic blood pressure (DBP) \\<=60 mmHg; 7) absolute DBP \\>=100 mmHg; 8) DBP maximum increase of \\>=10 mmHg from baseline; 9) DBP maximum increase of \\>=20 mmHg from baseline; 10) DBP maximum increase of \\>=30 mmHg from baseline; 11) absolute heart rate (HR) \\<50 beats per minute (bpm); 12) absolute HR \\>120 bpm.'}, {'measure': 'Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'timeFrame': 'Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D', 'timeFrame': 'Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.'}, {'measure': 'Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.'}, {'measure': 'Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.'}, {'measure': 'Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'timeFrame': 'Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D', 'timeFrame': 'Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.'}, {'measure': 'Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'timeFrame': 'Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.'}, {'measure': 'Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.'}, {'measure': 'Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'timeFrame': 'Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm B', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C', 'timeFrame': 'Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D', 'timeFrame': 'Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A', 'timeFrame': 'Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm B', 'timeFrame': 'Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.'}, {'measure': 'Number of Participants With Increase From Baseline in QT Interval', 'timeFrame': 'Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': "Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF) ."}, {'measure': 'Number of Participants With Maximum Post-dose QT Interval Corrected', 'timeFrame': 'Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)', 'description': "Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF)."}, {'measure': 'Percentage of Participants With Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.', 'description': 'CR was defined as the disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \\<10 mm). PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions.'}, {'measure': 'Progression-Free Survival (PFS) (Stage 2)', 'timeFrame': 'Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.', 'description': 'Progression-free survival (PFS) was the time from first dose to date of first documentation of progression or death due to any cause.'}, {'measure': 'Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D', 'timeFrame': 'Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)'}, {'measure': 'Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D', 'timeFrame': 'Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)'}, {'measure': 'Ratio to Baseline in Serum Glucose Level at Cycle 2 Day 16 for Arm A', 'timeFrame': 'Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)'}, {'measure': 'Ratio to Baseline in Serum Insulin Level at Cycle 2 Day 16 for Arm A', 'timeFrame': 'Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)'}, {'measure': 'Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling', 'timeFrame': 'Baseline and Cycle 1 Day 23.', 'description': 'Number of participants with expression of genes relating to PI3K, MAPK and/or Wnt pathway signaling (kirsten rat sarcoma 2 viral oncogene homolog \\[KRAS\\] and PTEN protein). Biopsies were obtained at baseline and Cycle 1 Day 23. Biomarker evaluation was performed on these biopsies.'}, {'measure': 'Duration of Response (Stage 2)', 'timeFrame': 'Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until until progression of disease was documented.', 'description': 'Duration of response was to be calculated for participants with an objective response. Duration of PR or CR was the time from start date (date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced metastatic cancer (solid tumors)', 'PI3K', 'mTOR', 'MEK'], 'conditions': ['Advanced Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1271002&StudyName=Clinical%20Study%20Of%20PI3K/mTOR%20Inhibitors%20In%20Combination%20With%20An%20Oral%20%20MEK%20Inhibitor%20Or%20Irinotecan%20In%20Patients%20With%20Advanced%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum tolerated doses are identified, further assessment of these combinations will be done in patients with previously treated metastatic colorectal or pancreatic cancer for the PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small cell lung cancer for the combination of PF-05212384 plus PD-0325901.', 'detailedDescription': 'The study was prematurely discontinued as a result of an internal portfolio review on April 1, 2015. The decision to terminate was not due to any safety or efficacy data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of advanced/metastatic solid tumor for which there is no currently clinically effective treatment.\n* All tumor types for patients enrolled in Stage 1 of Arm C.\n* For patients enrolled in Stage 2 of Arm C, advanced colorectal cancer (both KRAS mutated and KRAS wild type), which has progressed on irinotecan-based regimens, and pancreatic ductal adenocarcinoma after progression on first line treatment for metastatic/advanced disease.\n* For patients enrolled in Stage 1 of Arm D, tumors with KRAS or BRAF mutation (archived or fresh biopsy). Patients with tumors harboring other mutations that activate the MAPK pathway may be enrolled upon agreement with the Sponsor.\n* For patients enrolled in Stage 2 of Arm D, ovarian cancer which has progressed on prior platinum containing regimen or KRAS mutated non small cell lung cancer which has progressed on one prior regimen.\n* Patients with colorectal cancer enrolled to both Arms must:\n\n 1. have received at least 6 weeks of irinotecan-based therapy (either as single agent or in combination with cytotoxic drugs or in combination with targeted therapies) as the last prior treatment\n 2. have progressed on or within 1 month of completing this irinotecan-based regimen\n* All patients must provide an archived or fresh tumor sample.\n* For a subset of patients fresh tumor biopsies are mandatory:\n\n a. All patients with CRC enrolled to Stage 2 of Arm C must provide a fresh tumor biopsy at baseline. A subset of patients (10 or more) with at least 5 evaluable patients with CRC KRAS wild type must also provide tumor biopsy during treatment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 or 1\n* Adequate Bone Marrow, Renal, Cardiac, and Liver Function\n\nExclusion Criteria:\n\n* -Patients with known active brain metastases\n* -Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, ie, non target lesions), biological or investigational agents within 4 weeks of the start of the study treatment (6 weeks for mitomycin C or nitrosoureas).\n* -Any surgery (not including minor procedures such as lymph node biopsy, needle biopsy, and/or placement of port-a-cath) within 4 weeks of start of the study treatment; or not fully recovered from any side effects of previous procedures.\n* -In Arm D only: Patients with glaucoma, intraocular pressure \\> 21 mmHg, history of retinal vein occlusions, ocular ischemia or any other clinically significant abnormality in the ophthalmologic exam which would make the patient inappropriate for entry into this study\n* -For patients enrolling in Stage 2 prior therapy with an agent that is known or proposed to be active by action on PI3K and/or mTOR.\n* -Prior high dose chemotherapy requiring hematopoietic stem cell transplantation within 12 months of study treatment start.\n* -Known impaired pulmonary function or demonstrated to be impaired by Pulmonary Function Test (PFT) for patients who present with clinical suggestion of impairment.\n* -Uncontrolled or significant cardiovascular disease\n* -Current use or anticipated need for food or drugs that are known potent CYP3A4 inhibitors\n* \\- Current or anticipated need for food or drugs that are known potent CYP3A4 inducers'}, 'identificationModule': {'nctId': 'NCT01347866', 'briefTitle': 'Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multi-arm Phase 1 Dose Escalation Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of The Dual Pi3k/Mtor Inhibitors Pf-04691502 And Pf-05212384 In Combination With Experimental Or Approved Anticancer Agents In Patients With Advanced Cancer', 'orgStudyIdInfo': {'id': 'B1271002'}, 'secondaryIdInfos': [{'id': '2011-001671-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm D: PF-05212384 + PD-0325901', 'interventionNames': ['Drug: PF-05212384', 'Drug: PD-0325901']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: PF-05212384 + irinotecan', 'interventionNames': ['Drug: PF-05212384', 'Drug: irinotecan']}], 'interventions': [{'name': 'PF-05212384', 'type': 'DRUG', 'description': 'PF-05212384 intravenous infusion weekly starting at 110 mg.', 'armGroupLabels': ['Arm D: PF-05212384 + PD-0325901']}, {'name': 'PD-0325901', 'type': 'DRUG', 'description': 'PD-0325901 Oral twice daily (BID) dosing 2 mg BID 3 weeks on 1 week off', 'armGroupLabels': ['Arm D: PF-05212384 + PD-0325901']}, {'name': 'PF-05212384', 'type': 'DRUG', 'description': 'PF-05212384 intravenous infusion weekly starting at 95 mg.', 'armGroupLabels': ['Arm C: PF-05212384 + irinotecan']}, {'name': 'irinotecan', 'type': 'DRUG', 'description': 'Irinotecan by intravenous infusion at 180 mg/m2 every two weeks (Q x 2 week)', 'armGroupLabels': ['Arm C: PF-05212384 + irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-6984', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Oncology Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica - UCLA Medical Center and Orthopaedic Hospital', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Santa Monica Hematology Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Anschutz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver (CTRC)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital Anschutz Inpatient Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina, Hollings Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MUSC, Investigational Drug Services', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MUSC Health East Cooper', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29406', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MUSC Specialty Care-North', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital General Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}