Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-05-28 @ 10:42 PM
Study NCT ID:
NCT03314935
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2017-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 1385 days', 'description': 'Treatment-emergent adverse events, defined as any adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-defined in the Statistical Analysis Plan, data analysis was conducted based on treatment group and dose level, regardless of study phase, because the safety profile was expected to be generally uniform across tumor types.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and MSS-CRC (Phase 2) also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 4, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or solid metastatic tumors (Phase 1) and MSS-CRC (Phase 2) also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and MSS-CRC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'deathsNumAffected': 11, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with BTC or OC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. In Phase 1, participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 45, 'seriousNumAtRisk': 46, 'deathsNumAffected': 30, 'seriousNumAffected': 30}, {'id': 'EG006', 'title': 'Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 5, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel', 'description': 'In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and GC, EC, or OC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 50, 'seriousNumAtRisk': 52, 'deathsNumAffected': 36, 'seriousNumAffected': 27}, {'id': 'EG009', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 145, 'seriousNumAtRisk': 149, 'deathsNumAffected': 99, 'seriousNumAffected': 83}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 50, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 24, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ammonia increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 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'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 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'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': 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6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 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{'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '52', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and MSS-CRC (Phase 2) also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or solid metastatic tumors (Phase 1) and MSS-CRC (Phase 2) also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG002', 'title': 'Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and MSS-CRC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG003', 'title': 'Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with BTC or OC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. In Phase 1, participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle. In Phase 2, participants with BTC received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle, and participants with OC received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG006', 'title': 'Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG007', 'title': 'Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG008', 'title': 'Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel', 'description': 'In Phases 1 and 2, participants with advanced or metastatic solid tumors (Phase 1) and GC, EC, or OC (Phase 2) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants with advanced or metastatic solid tumors (Phase 1) and with GC, EC, or OC (Phase 2) also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1385 days', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all participants enrolled in the study who received at least 1 dose of INCB001158, mFOLFOX6, gemcitabine/cisplatin, or paclitaxel. As pre-defined in the Statistical Analysis Plan, data analysis was conducted based on treatment group and dose level, regardless of study phase, because the safety profile was expected to be generally uniform across tumor types.'}, {'type': 'PRIMARY', 'title': 'Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \\[m\\^2\\], leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 1: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG002', 'title': 'Phase 1: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG003', 'title': 'Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG006', 'title': 'Phase 1: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG007', 'title': 'Phase 1: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG008', 'title': 'Phase 1: INCB001158 100 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Day 28', 'description': 'A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 DLT Evaluable Population: all participants enrolled in Phase 1 who had been treated with the assigned dose level of INCB001158 and who had received at least 32 of the 42 doses prescribed for a 21-day cycle regimen or at least 42 of the 56 doses prescribed for a 28-day cycle regimen (both representing ≥ 75% of the dose planned) or who had experienced a DLT'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Phase 1 Participants', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50, 75, or 100 mg BID plus intravenous modified FOLFOX6, intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2, or intravenous paclitaxel 80 mg/m\\^2.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 580', 'description': 'The RP2D of the combination of INCB001158 and chemotherapy in 21-day (for gemcitabine/cisplatin) or 28-day (for mFOLFOX6 or paclitaxel) treatment cycles in participants with advanced or metastatic solid tumors was determined. After the dose escalation was completed, the INCB001158 dose level that was pharmacologically active and tolerable in combination with each chemotherapy regimen (i.e., maximum tolerated dose or lower) was determined to be the RP2D. The RP2D was then further assessed in tumor expansion cohorts in Phase 2.', 'unitOfMeasure': 'milligrams', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT Evaluable Population'}, {'type': 'PRIMARY', 'title': 'Phase 2: Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG002', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG003', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '42.3'}, {'value': '22.2', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '60.0'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '41.3'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '16.7', 'groupId': 'OG005', 'lowerLimit': '4.7', 'upperLimit': '37.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1385 days', 'description': 'ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 Response Evaluable Population: all participants who had received ≥1 dose of study treatment (INCB001158, mFOLFOX6, gemcitabine/cisplatin, or paclitaxel), completed a Baseline scan, and met ≥1 of the following criteria: (a) had ≥1 post-Baseline scan; (b) was in the study for a minimum of 63 days (8 weeks + 1 week window) of follow-up; (c) discontinued from study treatment'}, {'type': 'SECONDARY', 'title': 'Phase 1: ORR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \\[m\\^2\\], leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 1: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG002', 'title': 'Phase 1: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG003', 'title': 'Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG006', 'title': 'Phase 1: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG007', 'title': 'Phase 1: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG008', 'title': 'Phase 1: INCB001158 100 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '52.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '45.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '45.9'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '25.0', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '14.3', 'groupId': 'OG006', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '28.6', 'groupId': 'OG008', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 580 days', 'description': 'ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, as determined by investigator assessment of radiographic disease as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the Baseline sum diameters, no new lesions, and no progression of non-target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 Response Evaluable Population: all participants who had received ≥1 dose of study treatment (INCB001158, mFOLFOX6, gemcitabine/cisplatin, or paclitaxel), completed a Baseline scan, and met ≥1 of the following criteria: (a) had ≥1 post-Baseline scan; (b) was in the study for a minimum of 63 days (8 weeks + 1 week window) of follow-up; (c) discontinued from study treatment. Analysis was conducted by dose.'}, {'type': 'SECONDARY', 'title': 'Phases 1 and 2: Duration of Response', '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': '8', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \\[m\\^2\\], leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 1: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG002', 'title': 'Phase 1: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG003', 'title': 'Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG006', 'title': 'Phase 1: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG007', 'title': 'Phase 1: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG008', 'title': 'Phase 1: INCB001158 100 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG009', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158'}, {'id': 'OG010', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG011', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG012', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG013', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG014', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG010', 'lowerLimit': '4.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 368 days', 'description': 'DOR was defined as the time from initial objective response (CR or PR) (as determined by investigator assessment of radiographic disease assessment per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if it occurred sooner than disease progression. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response Evaluable Population. Analysis was conducted based on study phase. Analysis was conducted by dose in Phase 1 and by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates. Analysis was conducted in cohorts with \\>5 objective responders; the Kaplan Meier estimation method on a sample size of \\<5 responders is not valid. The confidence interval was calculated using the method of Brookmeyer and Crowley.'}, {'type': 'SECONDARY', 'title': 'Phases 1 and 2: Disease Control Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '33', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '24', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \\[m\\^2\\], leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 1: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG002', 'title': 'Phase 1: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG003', 'title': 'Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG006', 'title': 'Phase 1: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG007', 'title': 'Phase 1: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG008', 'title': 'Phase 1: INCB001158 100 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG009', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158'}, {'id': 'OG010', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG011', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG012', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG013', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG014', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '91.5'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '35.9', 'upperLimit': '99.6'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '64.1'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '75.0', 'groupId': 'OG004', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '42.9', 'groupId': 'OG006', 'lowerLimit': '9.9', 'upperLimit': '81.6'}, {'value': '60.0', 'groupId': 'OG007', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '85.7', 'groupId': 'OG008', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '100.0', 'groupId': 'OG009', 'lowerLimit': '63.1', 'upperLimit': '100.0'}, {'value': '66.7', 'groupId': 'OG010', 'lowerLimit': '48.2', 'upperLimit': '82.0'}, {'value': '88.9', 'groupId': 'OG011', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '54.5', 'groupId': 'OG012', 'lowerLimit': '23.4', 'upperLimit': '83.3'}, {'value': '80.0', 'groupId': 'OG013', 'lowerLimit': '44.4', 'upperLimit': '97.5'}, {'value': '66.7', 'groupId': 'OG014', 'lowerLimit': '44.7', 'upperLimit': '84.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1385 days', 'description': 'DCR was defined as the percentage of participants with an overall response of CR, PR, or stable disease (SD), as determined by investigator assessment of radiographic disease as per RECIST v1.1, for at least 8 weeks. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response Evaluable Population. Data analysis was conducted based on study phase. Additionally, analysis was conducted by dose in Phase 1 and by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates.'}, {'type': 'SECONDARY', 'title': 'Phases 1 and 2: Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '33', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}, {'value': '24', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \\[m\\^2\\], leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 1: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG002', 'title': 'Phase 1: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG003', 'title': 'Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'OG006', 'title': 'Phase 1: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG007', 'title': 'Phase 1: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG008', 'title': 'Phase 1: INCB001158 100 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG009', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158'}, {'id': 'OG010', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG011', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG012', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG013', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG014', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.9'}, {'value': '6.6', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': 'NA'}, {'value': '1.7', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': 'NA'}, {'value': '3.9', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': 'NA'}, {'value': '5.3', 'comment': 'The upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.4', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG005', 'lowerLimit': '3.7', 'upperLimit': 'NA'}, {'value': '3.9', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG006', 'lowerLimit': '0.8', 'upperLimit': 'NA'}, {'value': '3.7', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG007', 'lowerLimit': '1.5', 'upperLimit': 'NA'}, {'value': '11.8', 'groupId': 'OG008', 'lowerLimit': '1.7', 'upperLimit': '16.1'}, {'value': '3.7', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG009', 'lowerLimit': '2.8', 'upperLimit': 'NA'}, {'value': '8.5', 'groupId': 'OG010', 'lowerLimit': '5.7', 'upperLimit': '10.1'}, {'value': '7.8', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG011', 'lowerLimit': '2.2', 'upperLimit': 'NA'}, {'value': '3.5', 'comment': 'The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.', 'groupId': 'OG012', 'lowerLimit': '1.7', 'upperLimit': 'NA'}, {'value': '7.1', 'groupId': 'OG013', 'lowerLimit': '3.5', 'upperLimit': '11.1'}, {'value': '3.7', 'groupId': 'OG014', 'lowerLimit': '2.4', 'upperLimit': '4.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 1385 days', 'description': 'According to RECIST 1.1, PFS was defined as the length of time from the date of the first dose study of drug until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death due to any cause, if it occurred sooner than progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Data analysis was conducted based on study phase. Additionally, analysis was conducted by dose in Phase 1 and by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates. Median survival time was estimated using the Kaplan-Meier method. CI for median survival time was calculated using the method of Brookmeyer and Crowley.'}, {'type': 'SECONDARY', 'title': 'Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG002', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG003', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '747', 'spread': '35.7', 'groupId': 'OG000'}, {'value': '407', 'spread': '407', 'groupId': 'OG001'}, {'value': '268', 'spread': '888', 'groupId': 'OG002'}, {'value': '542', 'spread': '102', 'groupId': 'OG003'}, {'value': '1020', 'spread': '27.2', 'groupId': 'OG004'}, {'value': '633', 'spread': '131', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of Cycle 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycle 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'Cmin was defined as the minimum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 Pharmacokinetic (PK) Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG002', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG003', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1290', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '1350', 'spread': '35.2', 'groupId': 'OG001'}, {'value': '2160', 'spread': '22.3', 'groupId': 'OG002'}, {'value': '1100', 'spread': '68.0', 'groupId': 'OG003'}, {'value': '1760', 'spread': '17.2', 'groupId': 'OG004'}, {'value': '1640', 'spread': '23.2', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1960', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '1860', 'spread': '46.7', 'groupId': 'OG001'}, {'value': '2250', 'spread': '26.4', 'groupId': 'OG002'}, {'value': '1600', 'spread': '22.0', 'groupId': 'OG003'}, {'value': '2390', 'spread': '11.4', 'groupId': 'OG004'}, {'value': '2100', 'spread': '24.6', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'Cmax was defined as the maximum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 PK Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG002', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG003', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.13', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '6.10'}, {'value': '4.07', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '7.53'}, {'value': '4.08', 'groupId': 'OG002', 'lowerLimit': '3.67', 'upperLimit': '6.00'}, {'value': '5.05', 'groupId': 'OG003', 'lowerLimit': '2.25', 'upperLimit': '7.50'}, {'value': '4.09', 'groupId': 'OG004', 'lowerLimit': '2.00', 'upperLimit': '6.17'}, {'value': '3.97', 'groupId': 'OG005', 'lowerLimit': '1.78', 'upperLimit': '6.08'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '7.50'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '0.983', 'upperLimit': '7.53'}, {'value': '4.06', 'groupId': 'OG002', 'lowerLimit': '2.03', 'upperLimit': '6.02'}, {'value': '4.13', 'groupId': 'OG003', 'lowerLimit': '1.92', 'upperLimit': '7.53'}, {'value': '3.85', 'groupId': 'OG004', 'lowerLimit': '3.77', 'upperLimit': '3.92'}, {'value': '3.95', 'groupId': 'OG005', 'lowerLimit': '2.03', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'tmax was defined as the time to the maximum concentration. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 PK Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG002', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG003', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6910', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '7240', 'spread': '32.9', 'groupId': 'OG001'}, {'value': '10600', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '4680', 'spread': '134', 'groupId': 'OG003'}, {'value': '9290', 'spread': '33.2', 'groupId': 'OG004'}, {'value': '8840', 'spread': '24.7', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11000', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '10600', 'spread': '55.3', 'groupId': 'OG001'}, {'value': '12200', 'spread': '34.4', 'groupId': 'OG002'}, {'value': '10000', 'spread': '18.4', 'groupId': 'OG003'}, {'value': '14400', 'spread': '13.7', 'groupId': 'OG004'}, {'value': '12800', 'spread': '30.3', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.', 'unitOfMeasure': 'hours x ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 PK Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'OG001', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG002', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'OG003', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG004', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'OG005', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7.53', 'groupId': 'OG000', 'lowerLimit': '7.47', 'upperLimit': '8.00'}, {'value': '7.73', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '8.42'}, {'value': '7.53', 'groupId': 'OG002', 'lowerLimit': '7.50', 'upperLimit': '8.05'}, {'value': '7.50', 'groupId': 'OG003', 'lowerLimit': '3.50', 'upperLimit': '8.08'}, {'value': '7.53', 'groupId': 'OG004', 'lowerLimit': '7.50', 'upperLimit': '7.67'}, {'value': '7.65', 'groupId': 'OG005', 'lowerLimit': '5.73', 'upperLimit': '8.15'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7.50', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '7.57'}, {'value': '7.58', 'groupId': 'OG001', 'lowerLimit': '7.50', 'upperLimit': '8.38'}, {'value': '7.60', 'groupId': 'OG002', 'lowerLimit': '7.50', 'upperLimit': '8.25'}, {'value': '7.57', 'groupId': 'OG003', 'lowerLimit': '7.50', 'upperLimit': '8.00'}, {'value': '7.55', 'groupId': 'OG004', 'lowerLimit': '7.50', 'upperLimit': '7.67'}, {'value': '7.58', 'groupId': 'OG005', 'lowerLimit': '7.48', 'upperLimit': '8.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'tlast was defined as the time of the last sample collected from which a concentration was measured. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 PK Population. Only participants with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \\[m\\^2\\], leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'FG001', 'title': 'Phase 1: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'FG002', 'title': 'Phase 1: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'FG003', 'title': 'Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'FG004', 'title': 'Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'FG005', 'title': 'Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'FG006', 'title': 'Phase 1: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'FG007', 'title': 'Phase 1: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'FG008', 'title': 'Phase 1: INCB001158 100 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'FG009', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'FG010', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'FG011', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'FG012', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'FG013', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'FG014', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Captured as "Other" in Database', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '33'}, {'groupId': 'FG011', 'numSubjects': '9'}, {'groupId': 'FG012', 'numSubjects': '11'}, {'groupId': 'FG013', 'numSubjects': '10'}, {'groupId': 'FG014', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '33'}, {'groupId': 'FG011', 'numSubjects': '9'}, {'groupId': 'FG012', 'numSubjects': '11'}, {'groupId': 'FG013', 'numSubjects': '10'}, {'groupId': 'FG014', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '20'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '7'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '4'}, {'groupId': 'FG014', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study was conducted at 11 study centers in the United States, the United Kingdom, and Belgium.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '33', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '24', 'groupId': 'BG014'}, {'value': '149', 'groupId': 'BG015'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: INCB001158 50 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 milligrams (mg) twice daily (BID) starting on Day 1 of each 28-day cycle. Participants also received intravenous modified FOLFOX6 (mFOLFOX6: oxaliplatin 85 mg/meters squared \\[m\\^2\\], leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'BG001', 'title': 'Phase 1: INCB001158 75 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'BG002', 'title': 'Phase 1: INCB001158 100 mg + mFOLFOX6', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cyce after administration of INCB001158.'}, {'id': 'BG003', 'title': 'Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'BG004', 'title': 'Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'BG005', 'title': 'Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and Day 8 of each 28-day cycle.'}, {'id': 'BG006', 'title': 'Phase 1: INCB001158 50 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 50 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'BG007', 'title': 'Phase 1: INCB001158 75 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 75 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'BG008', 'title': 'Phase 1: INCB001158 100 mg + Paclitaxel', 'description': 'In Phase 1, participants with advanced or metastatic solid tumors received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'BG009', 'title': 'Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)', 'description': 'In Phase 2, participants with microsatellite-stable-colorectal cancer (MSS-CRC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous mFOLFOX6 (oxaliplatin 85 mg/m\\^2, leucovorin 400 mg/m\\^2, and 5-fluorouracil 400 mg/m\\^2 \\[bolus\\] and 2400 mg/m\\^2 \\[continuous infusion\\]) on Day 1 and Day 15 of each 28-day cycle after administration of INCB001158.'}, {'id': 'BG010', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)', 'description': 'In Phase 2, participants with biliary tract cancer (BTC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 1000 mg/m\\^2 and intravenous cisplatin 25 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'BG011', 'title': 'Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous gemcitabine 750 mg/m\\^2 and intravenous cisplatin 30 mg/m\\^2 on Day 1 and 8 of each 28-day cycle.'}, {'id': 'BG012', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)', 'description': 'In Phase 2, participants with gastroesophageal cancer (GC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'BG013', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)', 'description': 'In Phase 2, participants with endometrial cancer (EC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'BG014', 'title': 'Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)', 'description': 'In Phase 2, participants with ovarian cancer (OC) received oral INCB001158 100 mg BID starting on Day 1 of each 28-day cycle. Participants also received intravenous paclitaxel 80 mg/m\\^2 on Day 1, Day 8, and Day 15 of each 28-day cycle.'}, {'id': 'BG015', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '10.80', 'groupId': 'BG000'}, {'value': '60.3', 'spread': '9.93', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '7.99', 'groupId': 'BG002'}, {'value': '54.0', 'spread': '18.93', 'groupId': 'BG003'}, {'value': '64.5', 'spread': '16.82', 'groupId': 'BG004'}, {'value': '54.0', 'spread': '15.64', 'groupId': 'BG005'}, {'value': '62.0', 'spread': '14.57', 'groupId': 'BG006'}, {'value': '47.4', 'spread': '10.29', 'groupId': 'BG007'}, {'value': '61.4', 'spread': '6.95', 'groupId': 'BG008'}, {'value': '62.8', 'spread': '11.26', 'groupId': 'BG009'}, {'value': '59.3', 'spread': '12.74', 'groupId': 'BG010'}, {'value': '65.3', 'spread': '8.87', 'groupId': 'BG011'}, {'value': '58.8', 'spread': '11.90', 'groupId': 'BG012'}, {'value': '62.3', 'spread': '9.29', 'groupId': 'BG013'}, {'value': '60.6', 'spread': '9.04', 'groupId': 'BG014'}, {'value': '59.93', 'spread': '11.66', 'groupId': 'BG015'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '21', 'groupId': 'BG010'}, {'value': '9', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '24', 'groupId': 'BG014'}, {'value': '103', 'groupId': 'BG015'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '7', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '46', 'groupId': 'BG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '29', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '23', 'groupId': 'BG014'}, {'value': '136', 'groupId': 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{'title': 'Not Provided/Specified', 'categories': [{'measurements': [{'value': '1', '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': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}]}]}, {'title': 'Black/Carribean', 'categories': [{'measurements': [{'value': '1', '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'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}]}]}, {'title': 'Captured as Hispanic/Latino in Database', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', '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'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-09', 'size': 2584949, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-10T08:18', 'hasProtocol': True}, {'date': '2021-03-08', 'size': 723475, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-10T08:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2017-10-16', 'resultsFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-15', 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'up to 1385 days', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.'}, {'measure': 'Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)', 'timeFrame': 'up to Day 28', 'description': 'A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen', 'timeFrame': 'up to Day 580', 'description': 'The RP2D of the combination of INCB001158 and chemotherapy in 21-day (for gemcitabine/cisplatin) or 28-day (for mFOLFOX6 or paclitaxel) treatment cycles in participants with advanced or metastatic solid tumors was determined. After the dose escalation was completed, the INCB001158 dose level that was pharmacologically active and tolerable in combination with each chemotherapy regimen (i.e., maximum tolerated dose or lower) was determined to be the RP2D. The RP2D was then further assessed in tumor expansion cohorts in Phase 2.'}, {'measure': 'Phase 2: Objective Response Rate (ORR)', 'timeFrame': 'up to 1385 days', 'description': 'ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates.'}], 'secondaryOutcomes': [{'measure': 'Phase 1: ORR', 'timeFrame': 'up to 580 days', 'description': 'ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, as determined by investigator assessment of radiographic disease as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the Baseline sum diameters, no new lesions, and no progression of non-target lesions.'}, {'measure': 'Phases 1 and 2: Duration of Response', 'timeFrame': 'up to 368 days', 'description': 'DOR was defined as the time from initial objective response (CR or PR) (as determined by investigator assessment of radiographic disease assessment per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if it occurred sooner than disease progression. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.'}, {'measure': 'Phases 1 and 2: Disease Control Rate', 'timeFrame': 'up to 1385 days', 'description': 'DCR was defined as the percentage of participants with an overall response of CR, PR, or stable disease (SD), as determined by investigator assessment of radiographic disease as per RECIST v1.1, for at least 8 weeks. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.'}, {'measure': 'Phases 1 and 2: Progression-free Survival', 'timeFrame': 'up to 1385 days', 'description': 'According to RECIST 1.1, PFS was defined as the length of time from the date of the first dose study of drug until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death due to any cause, if it occurred sooner than progression.'}, {'measure': 'Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration', 'timeFrame': 'Day 1 of Cycle 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycle 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'Cmin was defined as the minimum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.'}, {'measure': 'Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration', 'timeFrame': 'Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'Cmax was defined as the maximum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.'}, {'measure': 'Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration', 'timeFrame': 'Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'tmax was defined as the time to the maximum concentration. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.'}, {'measure': 'AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration', 'timeFrame': 'Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.'}, {'measure': 'Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration', 'timeFrame': 'Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection', 'description': 'tlast was defined as the time of the last sample collected from which a concentration was measured. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['INCB001158', 'arginase inhibitor', 'oxaliplatin', 'leucovorin', '5 fluorouracil', 'gemcitabine', 'cisplatin', 'paclitaxel', 'solid tumors', 'colorectal cancer', 'biliary tract cancer', 'gastroesophageal cancer', 'endometrial cancer', 'ovarian cancer'], 'conditions': ['Biliary Tract Cancer (BTC)', 'Colorectal Cancer (CRC)', 'Endometrial Cancer', 'Gastroesophageal Cancer (GC)', 'Ovarian Cancer', 'Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '39462179', 'type': 'DERIVED', 'citation': 'Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.\n* Presence of measurable disease per RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.\n* Resolution of treatment-related toxicities.\n* Adequate hepatic, renal, cardiac, and hematologic function.\n* Additional cohort-specific criteria may apply.\n\nExclusion Criteria:\n\n* Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.\n* Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.\n* Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.\n* Has received prior approved radiotherapy within 14 days of study therapy.\n* Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Has an active infection requiring systemic therapy.\n* Has known active CNS metastases and/or carcinomatous meningitis.\n* Women who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03314935', 'briefTitle': 'A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'INCB 01158-203'}, 'secondaryIdInfos': [{'id': '2017-002904-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group A', 'description': 'INCB001158 + FOLFOX', 'interventionNames': ['Drug: INCB001158', 'Drug: Oxaliplatin', 'Drug: Leucovorin', 'Drug: 5-Fluorouracil']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group B', 'description': 'INCB001158 + gemcitabine/cisplatin', 'interventionNames': ['Drug: INCB001158', 'Drug: Gemcitabine', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group C', 'description': 'INCB001158 + paclitaxel', 'interventionNames': ['Drug: INCB001158', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'INCB001158', 'type': 'DRUG', 'otherNames': ['Arginase inhibitor'], 'description': 'Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.', 'armGroupLabels': ['Treatment Group A', 'Treatment Group B', 'Treatment Group C']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin administered intravenously at the protocol-defined dose and schedule.', 'armGroupLabels': ['Treatment Group A']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'Leucovorin at the protocol-defined dose and regimen.', 'armGroupLabels': ['Treatment Group A']}, {'name': '5-Fluorouracil', 'type': 'DRUG', 'description': '5-Fluorouracil at the protocol-defined dose and regimen.', 'armGroupLabels': ['Treatment Group A']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine at the protocol-defined dose and regimen.', 'armGroupLabels': ['Treatment Group B']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin at the protocol-defined dose and regimen.', 'armGroupLabels': ['Treatment Group B']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel at the protocol-defined dose and regimen.', 'armGroupLabels': ['Treatment Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'USA Mitchell Cancer Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis - Comprehensive Cancer Centre', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'START San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '6000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Grand Hopital de Charleroi - Department of Medical Oncology', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet - Clinical Trials Conduct Unit', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'WC1E 6BT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'UCL Cancer Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Lance Leopold, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'url': 'https://www.incyte.com/our-company/compliance-and-transparency', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.', 'ipdSharing': 'YES', 'description': 'Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThe trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency', 'accessCriteria': 'Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}