Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-06-24 @ 10:56 PM
Study NCT ID:
NCT02712905
Status:
TERMINATED
Last Update Posted:
2025-11-04
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730036', 'term': 'INCB059872'}, {'id': 'D014212', 'term': 'Tretinoin'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, '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}, 'limitationsAndCaveats': {'description': 'The study was terminated by the sponsor due to a strategic business decision.'}}, 'adverseEventsModule': {'timeFrame': 'up to 1387 days', 'description': 'Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'deathsNumAffected': 15, 'seriousNumAffected': 10}, {'id': 'EG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 35, 'seriousNumAtRisk': 36, 'deathsNumAffected': 27, 'seriousNumAffected': 24}, {'id': 'EG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG012', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 5, 'seriousNumAffected': 4}, {'id': 'EG013', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 6, 'seriousNumAffected': 4}, {'id': 'EG014', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 3, 'seriousNumAffected': 6}, {'id': 'EG016', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG017', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Actinomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 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[{'type': 'PRIMARY', 'title': 'Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '36', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '36', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 588 days', 'description': 'Adverse events (AEs) were 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). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all enrolled participants who received at least 1 dose of INCB059872, ATRA, azacitidine, or nivolumab'}, {'type': 'PRIMARY', 'title': 'Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1387 days', 'description': 'AEs were 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). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy', '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': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '36', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'title': 'SCLC', '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': '18', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': "Ewing's sarcoma", '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': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG009'}]}]}, {'title': 'Poorly differentiated neuroendocrine tumors', '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': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG009'}]}]}, {'title': 'Other solid tumors', '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': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '50.0', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 518 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or a partial response (PR), per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1), recorded before and including the first event of progressive disease (PD). 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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all enrolled participants who received at least 1 dose of INCB059872, ATRA, azacitidine, or nivolumab. Only participants with the indicated type of solid tumor who received monotherapy were analyzed.'}, {'type': 'SECONDARY', 'title': 'ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 85 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete remission or complete remission with incomplete hematologic recovery (CRi), per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: absolute neutrophil count (ANC) ≥1.0 x 10\\^9/Liter (L), platelet count ≥100 x 10\\^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be \\< 1.0 x 10\\^9/L and/or the platelet count may be \\<100 x 10\\^9/L.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with AML who received monotherapy were analyzed. The participant in Group A receiving 3 mg QOD was on treatment for less than a week and therefore was not evaluated for efficacy.'}, {'type': 'SECONDARY', 'title': 'ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 61 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: \\<5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 grams per deciliter (g/dL), neutrophils ≥1 x 10\\^9/L, platelets ≥100 x 10\\^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with MDS who received monotherapy were analyzed. The participant in Group A receiving 3 mg QOD was on treatment for less than a week and therefore was not evaluated for efficacy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Spleen Volume Reduction (SVR) at Week 12 in Participants With Myelofibrosis (MF) Who Received INCB059872 Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'timeFrame': 'Baseline; Week 12', 'description': 'Change from Baseline was to have been calculated as the post-Baseline value minus the Baseline value. SVR was to have been measured by magnetic resonance imaging (MRI), or by computed tomography (CT) scan in participants who were not candidates for MRI or when MRI was not readily available.', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Analysis was not conducted because no participants with MF remained in the study at Week 12.'}, {'type': 'SECONDARY', 'title': 'Cmax of INCB059872 in Plasma When Received as Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '29.2', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '73.1', 'spread': '30.5', 'groupId': 'OG003'}, {'value': '110', 'spread': '13.7', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG005'}, {'value': '25.7', 'spread': '21.8', 'groupId': 'OG006'}, {'value': '46.0', 'spread': '9.95', 'groupId': 'OG007'}, {'value': '70.6', 'spread': '25.6', 'groupId': 'OG009'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG010'}, {'value': '98.2', 'spread': '28.5', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'Cmax was defined as the maximum observed plasma concentration of INCB059872.', 'unitOfMeasure': 'nanomolar (nM)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of study treatment and provided at least 1 postdose PK sample'}, {'type': 'SECONDARY', 'title': 'Tmax of INCB059872 in Plasma When Received as Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '1'}, {'value': '0.5', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '1'}, {'value': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, median (full range) cannot be reported for a single participant.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG007', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG009', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, median (full range) cannot be reported for a single participant.', 'groupId': 'OG010', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.5', 'groupId': 'OG011', 'lowerLimit': '0.5', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'tmax was defined as the time to the maximum observed plasma concentration of INCB059872.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population'}, {'type': 'SECONDARY', 'title': 'AUC(0-τ) of INCB059872 in Plasma When Received as Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '196', 'spread': '8.38', 'groupId': 'OG000'}, {'value': '216', 'spread': '75.5', 'groupId': 'OG001'}, {'value': '374', 'spread': '120', 'groupId': 'OG003'}, {'value': '486', 'spread': '107', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG007'}, {'value': '361', 'spread': '115', 'groupId': 'OG009'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG010'}, {'value': '495', 'spread': '63.2', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.', 'unitOfMeasure': 'nM x hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 't1/2 of INCB059872 in Plasma When Received as Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'spread': '0.189', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '0.765', 'groupId': 'OG001'}, {'value': '3.13', 'spread': '0.495', 'groupId': 'OG003'}, {'value': '3.67', 'spread': '1.38', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG007'}, {'value': '3.57', 'spread': '0.52', 'groupId': 'OG009'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG010'}, {'value': '4.28', 'spread': '0.25', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 't1/2 was defined as the half-life of INCB059872.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'CL/F of INCB059872 in Plasma When Received as Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'OG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'OG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '9.31', 'groupId': 'OG001'}, {'value': '22.1', 'spread': '6.56', 'groupId': 'OG003'}, {'value': '22.1', 'spread': '5.57', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG007'}, {'value': '23.1', 'spread': '6.32', 'groupId': 'OG009'}, {'value': 'NA', 'spread': 'NA', 'comment': 'To protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.', 'groupId': 'OG010'}, {'value': '21.1', 'spread': '2.74', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'CL/F was defined as the apparent oral clearance of INCB059872.', 'unitOfMeasure': 'Liters per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'ORR in Participants With SCLC Who Received Combination Therapy', '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': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1353 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of CR or a PR, per investigator assessment according to RESIST v1.1, recorded before and including the first event of PD. 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', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with SCLC who received combination therapy and had available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 208 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete remission or CRi, per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: ANC ≥1.0 x 10\\^9/L, platelet count ≥100 x 10\\^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be \\< 1.0 x 10\\^9/L and/or the platelet count may be \\<100 x 10\\^9/L.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with AML who received combination therapy were analyzed.'}, {'type': 'SECONDARY', 'title': 'ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 85 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: \\<5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 g/dL, neutrophils ≥1 x 10\\^9/L, platelets ≥100 x 10\\^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with MDS who received combination therapy were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cmax of INCB059872 in Plasma When Received as Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '96.4', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '38.2', 'spread': '33.5', 'groupId': 'OG003'}, {'value': '78.0', 'spread': '26.3', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'Cmax was defined as the maximum observed plasma concentration of INCB059872.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-Evaluable Population'}, {'type': 'SECONDARY', 'title': 'Tmax of INCB059872 in Plasma When Received as Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.5'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1.0', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'tmax was defined as the time to the maximum observed plasma concentration of INCB059872.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-Evaluable Population'}, {'type': 'SECONDARY', 'title': 'AUC(0-τ) of INCB059872 in Plasma When Received as Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '225', 'spread': '85.9', 'groupId': 'OG000'}, {'value': '377', 'spread': '25.7', 'groupId': 'OG001'}, {'value': '273', 'spread': '24.4', 'groupId': 'OG003'}, {'value': '357', 'spread': '97.5', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.', 'unitOfMeasure': 'nM x hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-Evaluable Population'}, {'type': 'SECONDARY', 'title': 't1/2 of INCB059872 in Plasma When Received as Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.95', 'spread': '0.499', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '0.281', 'groupId': 'OG001'}, {'value': '3.08', 'spread': '0.040', 'groupId': 'OG003'}, {'value': '3.79', 'spread': '0.852', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 't1/2 was defined as the half-life of INCB059872.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-Evaluable Population'}, {'type': 'SECONDARY', 'title': 'CL/F of INCB059872 in Plasma When Received as Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG001', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG002', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'OG003', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG004', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'OG005', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'spread': '7.21', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '19.0', 'spread': '1.70', 'groupId': 'OG003'}, {'value': '23.5', 'spread': '8.14', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'CL/F was defined as the apparent oral clearance of INCB059872.', 'unitOfMeasure': 'Liters per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-Evaluable Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'FG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'FG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'FG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'FG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'FG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'FG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'FG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'FG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'FG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'FG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'FG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'FG012', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'FG013', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'FG014', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'FG015', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'FG016', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'FG017', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}], 'periods': [{'title': 'Monotherapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '36'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '36'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '27'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'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': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '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': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'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': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Started New Cancer Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}, {'title': 'Combination Therapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '7'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '7'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'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': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '7'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '7'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '6'}]}], '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': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '5'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '3'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '3'}]}, {'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': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '2'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}]}, {'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': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '2'}]}, {'type': 'Unknown; Did Not Complete End of Study Case Report Form Prior to Site Closure', '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': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were enrolled at 12 study sites: 10 in the United States and 1 each in Belgium and the Netherlands.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '36', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '7', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '115', 'groupId': 'BG018'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.'}, {'id': 'BG001', 'title': 'Group A: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.'}, {'id': 'BG002', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'BG003', 'title': 'Group A: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'BG004', 'title': 'Group A: INCB059872 Monotherapy; 4 mg QD', 'description': 'Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'BG005', 'title': 'Group A: INCB059872 Monotherapy; 5 mg QD', 'description': 'Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'BG006', 'title': 'Group B: INCB059872 Monotherapy; 1 mg QD', 'description': 'Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'BG007', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'BG008', 'title': 'Group B: INCB059872 Monotherapy; 2 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'BG009', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'BG010', 'title': 'Group B: INCB059872 Monotherapy; 3 mg QD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.'}, {'id': 'BG011', 'title': 'Group B: INCB059872 Monotherapy; 4 mg QOD', 'description': 'Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.'}, {'id': 'BG012', 'title': 'Group C: Combination Therapy; INCB059872 2 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \\[m\\^2\\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'BG013', 'title': 'Group C: Combination Therapy; INCB059872 3 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'BG014', 'title': 'Group C: Combination Therapy; INCB059872 4 mg QD + ATRA', 'description': 'Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.'}, {'id': 'BG015', 'title': 'Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'BG016', 'title': 'Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine', 'description': 'Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.'}, {'id': 'BG017', 'title': 'Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab', 'description': 'Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.'}, {'id': 'BG018', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '36', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}, {'value': '1', 'groupId': 'BG014'}, {'value': '7', 'groupId': 'BG015'}, {'value': '1', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '115', 'groupId': 'BG018'}]}], 'categories': [{'measurements': [{'value': '65.0', 'spread': '5.20', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '9.53', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Unable to report age for a single participant due to privacy concerns.', 'groupId': 'BG002'}, {'value': '57.4', 'spread': '21.93', 'groupId': 'BG003'}, {'value': '63.8', 'spread': '12.02', 'groupId': 'BG004'}, {'value': '51.0', 'spread': '18.38', 'groupId': 'BG005'}, {'value': '46.3', 'spread': '22.59', 'groupId': 'BG006'}, {'value': '63.0', 'spread': '17.09', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Unable to report age for a single participant due to privacy concerns.', 'groupId': 'BG008'}, {'value': '57.8', 'spread': '13.95', 'groupId': 'BG009'}, {'value': '51.0', 'spread': '11.53', 'groupId': 'BG010'}, {'value': '63.0', 'spread': '4.86', 'groupId': 'BG011'}, {'value': '61.0', 'spread': '9.19', 'groupId': 'BG012'}, {'value': '63.6', 'spread': '13.83', 'groupId': 'BG013'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Unable to report age for a single participant due to privacy concerns.', 'groupId': 'BG014'}, {'value': '73.4', 'spread': '9.02', 'groupId': 'BG015'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Unable to report age for a single participant due to privacy concerns.', 'groupId': 'BG016'}, {'value': '68.7', 'spread': '9.48', 'groupId': 'BG017'}, {'value': '60.8', 'spread': '13.39', 'groupId': 'BG018'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '36', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '7', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '111', 'groupId': 'BG018'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}, {'value': '3', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG017'}, {'value': '54', 'groupId': 'BG018'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG015'}, {'value': '3', 'groupId': 'BG017'}, {'value': '57', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '36', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '7', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '6', 'groupId': 'BG017'}, {'value': '111', 'groupId': 'BG018'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG017'}, {'value': '4', 'groupId': 'BG018'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '36', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG015'}, {'value': '6', 'groupId': 'BG017'}, {'value': '107', 'groupId': 'BG018'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '36', 'groupId': 'BG009'}, {'value': 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{'value': '6', 'groupId': 'BG017'}, {'value': '111', 'groupId': 'BG018'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG017'}, {'value': '2', 'groupId': 'BG018'}]}]}, {'title': 'Declined to Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': 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'BG018'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-15', 'size': 3349589, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-10T09:36', 'hasProtocol': True}, {'date': '2018-10-01', 'size': 1351887, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-10T09:36', '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': 116}}, 'statusModule': {'whyStopped': 'Strategic Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2016-02-18', 'resultsFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-05-15', 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'up to 588 days', 'description': 'Adverse events (AEs) were 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). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.'}, {'measure': 'Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE', 'timeFrame': 'up to 1387 days', 'description': 'AEs were 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). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy', 'timeFrame': 'up to 518 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or a partial response (PR), per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1), recorded before and including the first event of progressive disease (PD). 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.'}, {'measure': 'ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy', 'timeFrame': 'up to 85 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete remission or complete remission with incomplete hematologic recovery (CRi), per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: absolute neutrophil count (ANC) ≥1.0 x 10\\^9/Liter (L), platelet count ≥100 x 10\\^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be \\< 1.0 x 10\\^9/L and/or the platelet count may be \\<100 x 10\\^9/L.'}, {'measure': 'ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy', 'timeFrame': 'up to 61 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: \\<5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 grams per deciliter (g/dL), neutrophils ≥1 x 10\\^9/L, platelets ≥100 x 10\\^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.'}, {'measure': 'Change From Baseline in Spleen Volume Reduction (SVR) at Week 12 in Participants With Myelofibrosis (MF) Who Received INCB059872 Monotherapy', 'timeFrame': 'Baseline; Week 12', 'description': 'Change from Baseline was to have been calculated as the post-Baseline value minus the Baseline value. SVR was to have been measured by magnetic resonance imaging (MRI), or by computed tomography (CT) scan in participants who were not candidates for MRI or when MRI was not readily available.'}, {'measure': 'Cmax of INCB059872 in Plasma When Received as Monotherapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'Cmax was defined as the maximum observed plasma concentration of INCB059872.'}, {'measure': 'Tmax of INCB059872 in Plasma When Received as Monotherapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'tmax was defined as the time to the maximum observed plasma concentration of INCB059872.'}, {'measure': 'AUC(0-τ) of INCB059872 in Plasma When Received as Monotherapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.'}, {'measure': 't1/2 of INCB059872 in Plasma When Received as Monotherapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 't1/2 was defined as the half-life of INCB059872.'}, {'measure': 'CL/F of INCB059872 in Plasma When Received as Monotherapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'CL/F was defined as the apparent oral clearance of INCB059872.'}, {'measure': 'ORR in Participants With SCLC Who Received Combination Therapy', 'timeFrame': 'up to 1353 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of CR or a PR, per investigator assessment according to RESIST v1.1, recorded before and including the first event of PD. 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': 'ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy', 'timeFrame': 'up to 208 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete remission or CRi, per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: ANC ≥1.0 x 10\\^9/L, platelet count ≥100 x 10\\^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be \\< 1.0 x 10\\^9/L and/or the platelet count may be \\<100 x 10\\^9/L.'}, {'measure': 'ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy', 'timeFrame': 'up to 85 days', 'description': 'ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: \\<5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 g/dL, neutrophils ≥1 x 10\\^9/L, platelets ≥100 x 10\\^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.'}, {'measure': 'Cmax of INCB059872 in Plasma When Received as Combination Therapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'Cmax was defined as the maximum observed plasma concentration of INCB059872.'}, {'measure': 'Tmax of INCB059872 in Plasma When Received as Combination Therapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'tmax was defined as the time to the maximum observed plasma concentration of INCB059872.'}, {'measure': 'AUC(0-τ) of INCB059872 in Plasma When Received as Combination Therapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.'}, {'measure': 't1/2 of INCB059872 in Plasma When Received as Combination Therapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 't1/2 was defined as the half-life of INCB059872.'}, {'measure': 'CL/F of INCB059872 in Plasma When Received as Combination Therapy', 'timeFrame': 'Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose', 'description': 'CL/F was defined as the apparent oral clearance of INCB059872.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Acute myeloid leukemia (AML)', 'myelodysplastic syndrome (MDS)', 'small cell lung cancer (SCLC)', 'myelofibrosis (MF)', 'solid tumor, lysine-specific demethylase 1 (LSD1) inhibitor'], 'conditions': ['Solid Tumors and Hematologic Malignancy']}, 'descriptionModule': {'briefSummary': 'This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects, age 18 years or older.\n* Presence of measurable disease that has been confirmed by histology or cytology.\n* Must not be a candidate for potentially curative therapy or standard-of-care approved therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n\nExclusion Criteria:\n\n* Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.\n* Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve.\n* Laboratory and medical history parameters outside Protocol-defined range.\n* Known additional malignancy that is progressing or requires active treatment.'}, 'identificationModule': {'nctId': 'NCT02712905', 'briefTitle': 'An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'INCB 59872-101'}, 'secondaryIdInfos': [{'id': '2017-001710-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INCB059872', 'interventionNames': ['Drug: INCB059872']}, {'type': 'EXPERIMENTAL', 'label': 'INCB059872 in combination with other therapies', 'description': 'Initial cohort dose of INCB059872 to evaluate different doses of INCB0599872 in combination with other therapies in the following treatment groups:\n\n* Combination with all-trans retinoic acid (ATRA) in subjects with relapsed/refractory AML.\n* Combination with azacitidine in subjects with newly diagnosed, treatment-naive AML\n* Combination with nivolumab in subjects with advanced SCLC previously progressed on platinum-based treatment.\n\nUpon identification of the recommended dose(s) for each treatment combination, expansion cohorts of approximately 30 subjects in each treatment group may begin enrollment to further determine safety, tolerability, efficacy, PK, and PD of the selected dose(s).', 'interventionNames': ['Drug: INCB059872', 'Drug: all-trans retinoic acid (ATRA)', 'Drug: azacitidine', 'Drug: nivolumab']}], 'interventions': [{'name': 'INCB059872', 'type': 'DRUG', 'description': 'Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts.\n\nINCB059872 tablets to be administered by mouth.', 'armGroupLabels': ['INCB059872', 'INCB059872 in combination with other therapies']}, {'name': 'all-trans retinoic acid (ATRA)', 'type': 'DRUG', 'armGroupLabels': ['INCB059872 in combination with other therapies']}, {'name': 'azacitidine', 'type': 'DRUG', 'armGroupLabels': ['INCB059872 in combination with other therapies']}, {'name': 'nivolumab', 'type': 'DRUG', 'armGroupLabels': ['INCB059872 in combination with other therapies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35487', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60208', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66045', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Center for Research, Inc.', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10027', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97297', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Netherland Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Fred Zheng, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}