Viewing Study NCT02784795

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Ignite Creation Date: 2025-12-24 @ 1:53 PM
Ignite Modification Date: 2026-02-22 @ 9:37 AM
Study NCT ID: NCT02784795
Status: TERMINATED
Last Update Posted: 2025-08-21
First Post: 2016-05-25
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654634', 'term': 'crenigacestat'}, {'id': 'C581399', 'term': 'LY2940680'}, {'id': 'C000590451', 'term': 'abemaciclib'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'C000621566', 'term': 'LY3023414'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review and comment on results communications prior to public release and can embargo communications regarding trial results for a period that is more than 30 days but less than or equal to 90 days from the time the sponsor receives the publication for review. The sponsor can request that the PI hold publishing the communication in order to protect any intellectual property interest at stake.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated without triggering the dose expansion cohorts for Parts D and E due to business considerations.'}}, 'adverseEventsModule': {'timeFrame': 'Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E', 'description': 'All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)', 'description': '25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 3, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'deathsNumAffected': 9, 'seriousNumAffected': 9}, {'id': 'EG005', 'title': 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG007', 'title': 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG010', 'title': 'Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG011', 'title': 'Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 21, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 23, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 25, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 16, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear 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{'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With LY3039478 Dose-Limiting Toxicities (DLT) in Part A, B, C, D and E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG001', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG002', 'title': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG003', 'title': 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG004', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG005', 'title': 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG006', 'title': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG007', 'title': 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG008', 'title': 'Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG009', 'title': 'Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression'}, {'id': 'OG010', 'title': 'Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG011', 'title': 'Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to toxicity (up to end of Cycle 1 [1Cycle = 28 days for Part A, B and C and 21 days for Part D, E])', 'description': "DLT is defined as an adverse event (AE) during Cycle 1 (28 days for Part A, B and C and 21 days for Part D, E) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \\>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who receive at least one dose of study drug in Part A, B, C, D and E.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 in Combination With Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin in Part A, B, C, D and E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG001', 'title': 'Part B:25 mg LY3039478+150mg/200 mg LY3023414(Cohort 1 and 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period in cohort 1 and 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle in cohort 3.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG002', 'title': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG003', 'title': 'Part C:25 mg LY3039478+100 mg/150 mg Abema(Cohort 1 and 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period in cohort 1 and 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle in cohort 3.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG004', 'title': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG005', 'title': 'Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG006', 'title': 'Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression'}, {'id': 'OG007', 'title': 'Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG008', 'title': 'Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1210', 'spread': '41', 'groupId': 'OG005'}, {'value': '3080', 'spread': '35', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'AUC\\[0-∞\\] could not be calculated for one participant in the "Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)" Arm for the Day 1', 'groupId': 'OG007'}, {'value': '3400', 'spread': '70', 'groupId': 'OG008'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1030', 'spread': '9', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 1980 ng\\*h/mL.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual range = 804 -1400 ng\\*h/mL.', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual range = 3350 - 3620 ng\\*h/mL.', 'groupId': 'OG008'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 295 ng\\*h/mL.', 'groupId': 'OG000'}, {'value': '2660', 'spread': '31', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 4250 ng\\*h/mL.', 'groupId': 'OG002'}, {'value': '1820', 'spread': '44', 'groupId': 'OG003'}, {'value': '5080', 'spread': '12', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Parts A/B/C Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30 hours post-dose; Parts D/E Day 1 (Cycle 1) and 15 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6-8, 24-30 hours post-dose', 'description': 'AUC\\[0-∞\\] of LY3039478 in combination with taladegib, LY3023414, abemaciclib, cisplatin/gemcitabine, and gemcitabine/carboplatin in dose escalation parts of Part A, B, C, D and E was evaluated.', 'unitOfMeasure': 'nanogram*hour/mL (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug with intensive PK sampling in the dose escalation cohorts of Part A, B, C, D and E. PK data was interpreted by combining Part B (25 mg LY3039478 + 150/200 mg LY3023414; Cohorts 1 and 3) and Part C (25 mg LY3039478 + 100/150 mg abemaciclib; Cohorts 1 and 3) reporting arms as all participants received same dose of 50 mg LY3039478 (Part B and C Cohorts 1 and 2) and to increase the sample size for interpretability.'}, {'type': 'SECONDARY', 'title': 'PK: AUC[0-∞] of Taladegib and Its Active Metabolite LSN3185556, in Combination With LY3039478 (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period.\n\nParticipants receiving benefit may continue until disease progression.'}], 'classes': [{'title': 'Taladegib: Day -3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17100', 'spread': '48', 'groupId': 'OG000'}]}]}, {'title': 'Taladegib: Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 15400 ng\\*h/mL.', 'groupId': 'OG000'}]}]}, {'title': 'LSN3185556 (Metabolite): Day -3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31900', 'spread': '49', 'groupId': 'OG000'}]}]}, {'title': 'LSN3185556 (Metabolite): Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 26400 ng\\*h/mL.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -3 (Lead in) : pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose and Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose', 'description': 'AUC\\[0-∞\\] of taladegib and its active metabolite LSN3185556, in combination with LY3039478 (Part A) was evaluated.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug with evaluable PK data in Part A.'}, {'type': 'SECONDARY', 'title': 'PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day -3 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B:150 mg LY3023414 (Cohort 1 and Cohort 2)', 'description': 'A single dose of 150 mg LY3023414 was given on day 1 during a 3-day lead-in period.'}, {'id': 'OG001', 'title': 'Part B: 200 mg LY3023414 (Cohort 3)', 'description': 'A single dose of 200 mg LY3023414 was given on day 1 during a 3-day lead-in period.\n\nParticipants receiving benefit may continue until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '2620', 'spread': '52', 'groupId': 'OG000'}, {'value': '2780', 'spread': '69', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -3 (Lead in): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose', 'description': 'AUC\\[0-∞\\] of LY3023414 in combination with LY3039478 (Part B) on day -3 was evaluated.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants who received at least one dose of study drug with evaluable PK data in Part B. Day -3 Cohort 1 and 2 results for Parts B were combined as 'Part B:150 mg LY3023414 (Cohort 1 and Cohort 2)' since they are from same dose and were collected in the absence of LY3039478 co-administration. Part B Cohort 4 participants had sparse PK sampling limited to day 22 so day -3 PK results are not available/reported."}, {'type': 'SECONDARY', 'title': 'PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day 22 (Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG001', 'title': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG002', 'title': 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '2120', 'spread': '50', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 2480 ng\\*h/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2900 - 12000 ng\\*h/mL.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose', 'description': 'AUC\\[0-∞\\] of LY3023414 in combination with LY3039478 (Part B) on day 22 was evaluated. LY3023414 PK data is summarized only for dose escalation patients in Part B with intensive PK sampling.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug with intensive PK sampling in the dose escalation cohort of Part B'}, {'type': 'SECONDARY', 'title': 'PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day -3 (Part C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C:100 mg Abemaciclib (Cohort 1 and Cohort 2)', 'description': 'A single dose of 100 mg abemaciclib was given on day 1 during a 3-day lead-in period.'}, {'id': 'OG001', 'title': 'Part C:150 mg Abemaciclib (Cohort 3)', 'description': 'A single dose of 150 mg abemaciclib was given on day 1 during a 3-day lead-in period.\n\nParticipants receiving benefit may continue until disease progression.'}], 'classes': [{'title': 'Abemaciclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4570', 'spread': '78', 'groupId': 'OG000'}, {'value': '3240', 'spread': '109', 'groupId': 'OG001'}]}]}, {'title': 'LSN2839567 (Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '778', 'spread': '65', 'groupId': 'OG000'}, {'value': '663', 'spread': '82', 'groupId': 'OG001'}]}]}, {'title': 'LSN3106726 (Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1700', 'spread': '59', 'groupId': 'OG000'}, {'value': '1510', 'spread': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -3 (Lead in): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose', 'description': 'AUC\\[0-∞\\] of abemaciclib and AUC\\[0-tlast\\] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 3 (Part C) was evaluated.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug with evaluable PK data in Part C. Day -3 Cohort 1 and 2 results for Parts B were combined as Part C: 100 mg Abemaciclib (Cohort 1 and Cohort 2) since they are from same dose and were collected in the absence of LY3039478 co-administration.'}, {'type': 'SECONDARY', 'title': 'PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day 22 (Part C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG001', 'title': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG002', 'title': 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 150 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}], 'classes': [{'title': 'Abemaciclib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5270', 'spread': '88', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2510 - 6370 ng\\*h/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 3420 ng\\*h/mL.', 'groupId': 'OG002'}]}]}, {'title': 'LSN2839567 (Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1460', 'spread': '82', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 2130 ng\\*h/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 914 ng\\*h/mL.', 'groupId': 'OG002'}]}]}, {'title': 'LSN3106726 (Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2150 - 2690 ng\\*h/mL.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 4120 ng\\*h/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data reported as individual values when participants analyzed (n) were less than 3. Individual value = 2590 ng\\*h/mL.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose', 'description': 'AUC\\[0-∞\\] of abemaciclib and AUC\\[0-tlast\\] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 22 (Part C) was evaluated.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug with evaluable PK data in Part C.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG001', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG002', 'title': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG003', 'title': 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG004', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG005', 'title': 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG006', 'title': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG007', 'title': 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG008', 'title': 'Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG009', 'title': 'Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression'}, {'id': 'OG010', 'title': 'Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG011', 'title': 'Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}], 'timeFrame': 'Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Up To 12 Months)', 'description': 'DoR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of Response was not calculated for any participant as the study was terminated prior to data collection.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) Time in Part A, B, C, D and E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG001', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG002', 'title': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG003', 'title': 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG004', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG005', 'title': 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG006', 'title': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG007', 'title': 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG008', 'title': 'Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG009', 'title': 'Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression'}, {'id': 'OG010', 'title': 'Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'OG011', 'title': 'Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.91'}, {'value': '1.91', 'groupId': 'OG001', 'lowerLimit': '1.35', 'upperLimit': '2.00'}, {'value': 'NA', 'comment': 'There were no events in Part B of Cohort 2.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.91', 'groupId': 'OG003', 'lowerLimit': '1.87', 'upperLimit': '7.69'}, {'value': '1.84', 'groupId': 'OG004', 'lowerLimit': '0.92', 'upperLimit': '3.68'}, {'value': '1.94', 'groupId': 'OG005', 'lowerLimit': '1.61', 'upperLimit': '11.53'}, {'value': '1.91', 'groupId': 'OG006', 'lowerLimit': '1.38', 'upperLimit': '5.72'}, {'value': 'NA', 'comment': 'The upper limit of the 95% confidence Interval (CI) was not calculated due to the high censoring rate.', 'groupId': 'OG007', 'lowerLimit': '1.74', 'upperLimit': 'NA'}, {'value': '3.22', 'comment': 'The upper limit of the 95% confidence Interval (CI) was not calculated due to the high censoring rate.', 'groupId': 'OG008', 'lowerLimit': '2.96', 'upperLimit': 'NA'}, {'value': '3.02', 'groupId': 'OG009', 'lowerLimit': '1.15', 'upperLimit': '3.48'}, {'value': '6.00', 'groupId': 'OG010', 'lowerLimit': '4.96', 'upperLimit': '7.03'}, {'value': '4.71', 'groupId': 'OG011', 'lowerLimit': '3.06', 'upperLimit': '6.21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Objective Disease Progression or Death (Up To 1.91 Months for Part A, 7.69 Months for Part B, 11.53 Months for Part C, 19.52 Months for Part D, 7.03 Months for Part E)', 'description': 'PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. PFS time was summarized using Kaplan-Meier estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Part A, B, C, D and E. Censored participants: Part A= 2, Part B = 0, 4, 2 and 7, Part C = 0, 6 and 5, Part D = 2, 3, Part E = 3, 7.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A:25 Milligram(mg) LY3039478+200 mg Taladegib(Cohort 1)', 'description': '25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period for pharmacokinetic (PK) evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG001', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG002', 'title': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG003', 'title': 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 200 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG004', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG005', 'title': 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG006', 'title': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG007', 'title': 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 150 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG008', 'title': 'Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG009', 'title': 'Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression'}, {'id': 'FG010', 'title': 'Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'FG011', 'title': 'Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '10'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '10'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '10'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '10'}]}, {'type': 'Completed at Least 1 Treatment Cycle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '10'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '10'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'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'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study consists of 5 separate, parallel dose escalations (dose esc) followed by dose-confirmation (dose conf) study parts (Part A - E). LY3039478 is given in combination with taladegib for Part A, LY3023414 for Part B, abemaciclib (abema) for Part C, cisplatin (cis) and gemcitabine (gem) for Part C, and gemcitabine and carboplatin (carb) for Part E. A participant completed the study if they completed at least 1 cycle (1 cycle = 28 days for Part A, B and C and 21 days for Part D, E) .'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}, {'value': '94', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG001', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG002', 'title': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG003', 'title': 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG004', 'title': 'Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG005', 'title': 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG006', 'title': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG007', 'title': 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG008', 'title': 'Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG009', 'title': 'Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression'}, {'id': 'BG010', 'title': 'Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG011', 'title': 'Part E:50 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '16.8', 'groupId': 'BG000'}, {'value': '53.0', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '3.9', 'groupId': 'BG002'}, {'value': '56.6', 'spread': '11.8', 'groupId': 'BG003'}, {'value': '47.2', 'spread': '13.4', 'groupId': 'BG004'}, {'value': '60.0', 'spread': '11.8', 'groupId': 'BG005'}, {'value': '54.3', 'spread': '11.4', 'groupId': 'BG006'}, {'value': '51.1', 'spread': '13.9', 'groupId': 'BG007'}, {'value': '59.7', 'spread': '8.6', 'groupId': 'BG008'}, {'value': '52.6', 'spread': '12.9', 'groupId': 'BG009'}, {'value': '62.8', 'spread': '6.8', 'groupId': 'BG010'}, {'value': '53.6', 'spread': '12.2', 'groupId': 'BG011'}, {'value': '54.0', 'spread': '12.43', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '54', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '40', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '10', 'groupId': 'BG012'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '78', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '78', 'groupId': 'BG012'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '34', 'groupId': 'BG012'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '36', 'groupId': 'BG012'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '23', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants in Part A, B, C, D and E.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-15', 'size': 1076520, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-05T02:24', 'hasProtocol': True}, {'date': '2016-08-01', 'size': 3490388, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-05T02:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'As per the study protocol design description, the study was conducted as multicenter, nonrandomized, open-label, Phase 1b study consisting of 5 separate, parallel dose escalations in patients with advanced/metastatic cancer from a variety of solid tumors followed by a dose-confirmation phase in specified tumor types.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'whyStopped': 'The study was terminated due to business considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2016-05-25', 'resultsFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-01', 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With LY3039478 Dose-Limiting Toxicities (DLT) in Part A, B, C, D and E', 'timeFrame': 'Baseline to toxicity (up to end of Cycle 1 [1Cycle = 28 days for Part A, B and C and 21 days for Part D, E])', 'description': "DLT is defined as an adverse event (AE) during Cycle 1 (28 days for Part A, B and C and 21 days for Part D, E) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \\>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia."}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 in Combination With Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin in Part A, B, C, D and E', 'timeFrame': 'Parts A/B/C Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30 hours post-dose; Parts D/E Day 1 (Cycle 1) and 15 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6-8, 24-30 hours post-dose', 'description': 'AUC\\[0-∞\\] of LY3039478 in combination with taladegib, LY3023414, abemaciclib, cisplatin/gemcitabine, and gemcitabine/carboplatin in dose escalation parts of Part A, B, C, D and E was evaluated.'}, {'measure': 'PK: AUC[0-∞] of Taladegib and Its Active Metabolite LSN3185556, in Combination With LY3039478 (Part A)', 'timeFrame': 'Day -3 (Lead in) : pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose and Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose', 'description': 'AUC\\[0-∞\\] of taladegib and its active metabolite LSN3185556, in combination with LY3039478 (Part A) was evaluated.'}, {'measure': 'PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day -3 (Part B)', 'timeFrame': 'Day -3 (Lead in): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose', 'description': 'AUC\\[0-∞\\] of LY3023414 in combination with LY3039478 (Part B) on day -3 was evaluated.'}, {'measure': 'PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day 22 (Part B)', 'timeFrame': 'Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose', 'description': 'AUC\\[0-∞\\] of LY3023414 in combination with LY3039478 (Part B) on day 22 was evaluated. LY3023414 PK data is summarized only for dose escalation patients in Part B with intensive PK sampling.'}, {'measure': 'PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day -3 (Part C)', 'timeFrame': 'Day -3 (Lead in): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30, 72 hours post-dose', 'description': 'AUC\\[0-∞\\] of abemaciclib and AUC\\[0-tlast\\] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 3 (Part C) was evaluated.'}, {'measure': 'PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day 22 (Part C)', 'timeFrame': 'Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose', 'description': 'AUC\\[0-∞\\] of abemaciclib and AUC\\[0-tlast\\] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 22 (Part C) was evaluated.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Up To 12 Months)', 'description': 'DoR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.'}, {'measure': 'Progression Free Survival (PFS) Time in Part A, B, C, D and E', 'timeFrame': 'Baseline to Objective Disease Progression or Death (Up To 1.91 Months for Part A, 7.69 Months for Part B, 11.53 Months for Part C, 19.52 Months for Part D, 7.03 Months for Part E)', 'description': 'PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. PFS time was summarized using Kaplan-Meier estimates.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Notch Inhibitor'], 'conditions': ['Solid Tumor', 'Breast Cancer', 'Colon Cancer', 'Cholangiocarcinoma', 'Soft Tissue Sarcoma']}, 'referencesModule': {'references': [{'pmid': '36030462', 'type': 'DERIVED', 'citation': 'Massard C, Cassier PA, Azaro A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of crenigacestat (LY3039478) in combination with gemcitabine and cisplatin or gemcitabine and carboplatin in patients with advanced or metastatic solid tumors. Cancer Chemother Pharmacol. 2022 Oct;90(4):335-344. doi: 10.1007/s00280-022-04461-z. Epub 2022 Aug 28.'}, {'pmid': '33686452', 'type': 'DERIVED', 'citation': 'Azaro A, Massard C, Tap WD, Cassier PA, Merchan J, Italiano A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of the Notch inhibitor crenigacestat (LY3039478) in combination with other anticancer target agents (taladegib, LY3023414, or abemaciclib) in patients with advanced or metastatic solid tumors. Invest New Drugs. 2021 Aug;39(4):1089-1098. doi: 10.1007/s10637-021-01094-6. Epub 2021 Mar 8.'}], 'seeAlsoLinks': [{'url': 'https://lillytrialguide.com/en/studies/solid-tumor/JJCD#?postal=', 'label': 'Click here for more information about this study:A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.\n\n * For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.\n * For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.\n * For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.\n * For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.\n * For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received \\>1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).\n * For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received \\>2 lines of systemic treatment for advanced or metastatic TNBC.\n* Have adequate organ function.\n* Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.\n* Have discontinued all previous therapies for cancer.\n\nExclusion Criteria:\n\n* Have current acute leukemia.\n* Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.'}, 'identificationModule': {'nctId': 'NCT02784795', 'briefTitle': 'A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': '16209'}, 'secondaryIdInfos': [{'id': 'I6F-MC-JJCD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2015-004421-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: 25 milligram (mg) LY3039478 + 200 mg Taladegib (Cohort 1)', 'description': '25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period for pharmacokinetic (PK) evaluation.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: Taladegib']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 25 mg LY3039478 + 150 mg LY3023414 (Cohort 1 - Dose Escalation)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: LY3023414']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: LY3023414']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 200 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: LY3023414']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 25 mg LY3039478 + 150 mg LY3023414 (Cohort 4 - Dose Confirmation)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: LY3023414']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: Abemaciclib']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: Abemaciclib']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'description': '25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 150 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: Abemaciclib']}, {'type': 'EXPERIMENTAL', 'label': 'Part D:25 mg LY3039478+25 Milligram/Square Meter (mg/m2) Cisplatin+1000 mg/m2 Gemcitabine (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: Cisplatin', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Part D: 50 mg LY3039478 + 25 mg/m2 Cisplatin + 1000 mg/m2 Gemcitabine (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: Cisplatin', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Part E: 25 mg LY3039478 + 1000 mg/m2 Gemcitabine + Carboplatin (Cohort 1)', 'description': '25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: Gemcitabine', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part E: 50 mg LY3039478 + 1000 mg/m2 Gemcitabine + Carboplatin (Cohort 2)', 'description': '50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.\n\nParticipants receiving benefit may continue until disease progression.', 'interventionNames': ['Drug: LY3039478', 'Drug: Gemcitabine', 'Drug: Carboplatin']}], 'interventions': [{'name': 'LY3039478', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Part A: 25 milligram (mg) LY3039478 + 200 mg Taladegib (Cohort 1)', 'Part B: 25 mg LY3039478 + 150 mg LY3023414 (Cohort 1 - Dose Escalation)', 'Part B: 25 mg LY3039478 + 150 mg LY3023414 (Cohort 4 - Dose Confirmation)', 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)', 'Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)', 'Part D: 50 mg LY3039478 + 25 mg/m2 Cisplatin + 1000 mg/m2 Gemcitabine (Cohort 2)', 'Part D:25 mg LY3039478+25 Milligram/Square Meter (mg/m2) Cisplatin+1000 mg/m2 Gemcitabine (Cohort 1)', 'Part E: 25 mg LY3039478 + 1000 mg/m2 Gemcitabine + Carboplatin (Cohort 1)', 'Part E: 50 mg LY3039478 + 1000 mg/m2 Gemcitabine + Carboplatin (Cohort 2)']}, {'name': 'Taladegib', 'type': 'DRUG', 'otherNames': ['LY2940680'], 'description': 'Administered orally', 'armGroupLabels': ['Part A: 25 milligram (mg) LY3039478 + 200 mg Taladegib (Cohort 1)']}, {'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['LY2835219'], 'description': 'Administered orally', 'armGroupLabels': ['Part C: 25 mg LY3039478 + 100 mg Abemaciclib (Cohort 1)', 'Part C: 25 mg LY3039478 + 150 mg Abemaciclib (Cohort 3)', 'Part C: 50 mg LY3039478 + 100 mg Abemaciclib (Cohort 2)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part D: 50 mg LY3039478 + 25 mg/m2 Cisplatin + 1000 mg/m2 Gemcitabine (Cohort 2)', 'Part D:25 mg LY3039478+25 Milligram/Square Meter (mg/m2) Cisplatin+1000 mg/m2 Gemcitabine (Cohort 1)']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part D: 50 mg LY3039478 + 25 mg/m2 Cisplatin + 1000 mg/m2 Gemcitabine (Cohort 2)', 'Part D:25 mg LY3039478+25 Milligram/Square Meter (mg/m2) Cisplatin+1000 mg/m2 Gemcitabine (Cohort 1)', 'Part E: 25 mg LY3039478 + 1000 mg/m2 Gemcitabine + Carboplatin (Cohort 1)', 'Part E: 50 mg LY3039478 + 1000 mg/m2 Gemcitabine + Carboplatin (Cohort 2)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part E: 25 mg LY3039478 + 1000 mg/m2 Gemcitabine + Carboplatin (Cohort 1)', 'Part E: 50 mg LY3039478 + 1000 mg/m2 Gemcitabine + Carboplatin (Cohort 2)']}, {'name': 'LY3023414', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Part B: 25 mg LY3039478 + 150 mg LY3023414 (Cohort 1 - Dose Escalation)', 'Part B: 25 mg LY3039478 + 150 mg LY3023414 (Cohort 4 - Dose Confirmation)', 'Part B: 25 mg LY3039478 + 200 mg LY3023414 (Cohort 3)', 'Part B: 50 mg LY3039478 + 150 mg LY3023414 (Cohort 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2100', 'city': 'Copenhagen', 'state': 'København Ø', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Madrid Norte Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}