Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02193958
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2014-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fphucontact@fujifilm.com', 'phone': '(617) 945-3763', 'title': 'Vice President of Clinical Operations', 'organization': 'FUJIFILM Pharmaceuticals U.S.A, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.', 'description': 'Definitions do not differ from clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 Cohort 1: 50mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Phase 1 Cohort 2: 100mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Phase 1 Cohort 3: 200mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Phase 1 Cohort 4: 300mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Phase 1 Cohort 5: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 7, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'Phase 1 Cohort 6: 500mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 4, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Phase 1 Cohort 7: 400mg/m2', 'description': 'FF-10501-01 tablets BID every 21 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Phase 1 Cohort 8: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 28 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 5, 'seriousNumAffected': 7}, {'id': 'EG008', 'title': 'Phase 2a Cohort 9: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'deathsNumAffected': 8, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'decreased appetitie', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety Assessed by Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 Cohort 1: 50mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG001', 'title': 'Phase 1 Cohort 2: 100mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG002', 'title': 'Phase 1 Cohort 3: 200mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG003', 'title': 'Phase 1 Cohort 4: 300mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG004', 'title': 'Phase 1 Cohort 5: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG005', 'title': 'Phase 1 Cohort 6: 500mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG006', 'title': 'Phase 1 Cohort 7: 400mg/m2', 'description': 'FF-10501-01 tablets BID every 21 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG007', 'title': 'Phase 1 Cohort 8: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 28 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG008', 'title': 'Phase 2a Cohort 9: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}]}]}, {'title': 'Any study drug related TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}]}]}, {'title': 'Any serious TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 or 4 TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 or 4 study drug related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}]}, {'title': 'Interruption of study drug due to TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'Death due to TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Determination of Objective Response (OR) Rates.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 Cohort 1: 50mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG001', 'title': 'Phase 1 Cohort 2: 100mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG002', 'title': 'Phase 1 Cohort 3: 200mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG003', 'title': 'Phase 1 Cohort 4: 300mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG004', 'title': 'Phase 1 Cohort 5: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG005', 'title': 'Phase 1 Cohort 6: 500mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG006', 'title': 'Phase 1 Cohort 7: 400mg/m2', 'description': 'FF-10501-01 tablets BID every 21 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG007', 'title': 'Phase 1 Cohort 8: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 28 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'OG008', 'title': 'Phase 2a Cohort 9: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}], 'classes': [{'title': 'Partial Response subjects', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Complete bone marrow remission (mCR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'OR responses were assessed at end of Cycles 1 thru 3. Each cycle was 28 days in length.', 'description': 'The OR endpoint: proportion of subjects w/ OR as best response (CR, CRi or PR) assessed at the end of Cycles 1 and 3.\n\nAML: CR - free of all symptoms related to leukemia, absolute neutrophil count \\> 1.0 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, normal bone marrow with \\< 5% blasts no Auer rods; CRi - CR with residual thrombocytopenia (platelet count \\< 100 x 10\\^9/L) or residual neutropenia (absolute neutrophil count \\< 1.0 x 10\\^9/L); PR - A ≥ 50% decrease in bone marrow blasts to 5 to 25% abnormal.\n\nMDS or CMML: CR - free of all symptoms related to leukemia, absolute neutrophil count ≥ 1.0 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, bone marrow ≤ 5% myeloblasts, w/ normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood; PR - All CR criteria with ≥50% decrease in bone marrow blasts over pre-treatment (but still \\> 5%); Marrow CR - In bone marrow, ≤ 5% myeloblasts and decrease by ≥ 50% over pre-treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1 Cohort 1: 50mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'FG001', 'title': 'Phase 1 Cohort 2: 100mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'FG002', 'title': 'Phase 1 Cohort 3: 200mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'FG003', 'title': 'Phase 1 Cohort 4: 300mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'FG004', 'title': 'Phase 1 Cohort 5: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'FG005', 'title': 'Phase 1 Cohort 6: 500mg/m2', 'description': 'FF-10501-01 tablets BID every 14 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'FG006', 'title': 'Phase 1 Cohort 7: 400mg/m2 in MDS/CMML', 'description': 'FF-10501-01 tablets BID for 21 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'FG007', 'title': 'Phase 1 Cohort 8: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 28 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'FG008', 'title': 'Phase 2a Cohort 9: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 21 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '17'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'Participants were recruited based on physician referral at 2 academic medical centers between July 2014 and December 2018. The first participant was enrolled on August 21, 2014 and the last participant was enrolled on December 3, 2018. Study completion date was August 9, 2019.', 'preAssignmentDetails': 'For Phase 1, anticipated enrollment was 48 subjects; 38 subjects were enrolled and treated with FF-10501-01.\n\nFor Phase 2, anticipated enrollment was 20 subjects; 17 were enrolled and treated with FF-10501-01.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '55', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1 Cohort 1: 50mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG001', 'title': 'Phase 1 Cohort 2: 100mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG002', 'title': 'Phase 1 Cohort 3: 200mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG003', 'title': 'Phase 1 Cohort 4: 300mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG004', 'title': 'Phase 1 Cohort 5: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG005', 'title': 'Phase 1 Cohort 6: 500mg/m2', 'description': 'FF-10501-01 tablets BID for 14 days of a 28-day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG006', 'title': 'Phase 1 Cohort 7: 400mg/m2', 'description': 'FF-10501-01 tablets BID every 21 days of a 28 day cycle.\n\nFF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG007', 'title': 'Phase 1 Cohort 8: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 28 days of a 28-day cycle\n\nFF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG008', 'title': 'Phase 2a Cohort 9: 400mg/m2', 'description': 'FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '47', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.67', 'spread': '4.04', 'groupId': 'BG000'}, {'value': '69.00', 'spread': '11.79', 'groupId': 'BG001'}, {'value': '66.25', 'spread': '9.36', 'groupId': 'BG002'}, {'value': '76.00', 'spread': '5.35', 'groupId': 'BG003'}, {'value': '79.00', 'spread': '5.72', 'groupId': 'BG004'}, {'value': '71.00', 'spread': '9.14', 'groupId': 'BG005'}, {'value': '77.40', 'spread': '3.78', 'groupId': 'BG006'}, {'value': '73.29', 'spread': '9.36', 'groupId': 'BG007'}, {'value': '73.00', 'spread': '6.68', 'groupId': 'BG008'}, {'value': '73.44', 'spread': '7.355', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '34', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '41', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '49', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '55', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-12', 'size': 1120667, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-10T15:17', 'hasProtocol': True}, {'date': '2018-09-04', 'size': 316669, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-10T15:20', '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': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2014-07-14', 'resultsFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2014-07-16', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-13', 'studyFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Assessed by Adverse Events', 'timeFrame': '12 months', 'description': 'Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity'}], 'secondaryOutcomes': [{'measure': 'Determination of Objective Response (OR) Rates.', 'timeFrame': 'OR responses were assessed at end of Cycles 1 thru 3. Each cycle was 28 days in length.', 'description': 'The OR endpoint: proportion of subjects w/ OR as best response (CR, CRi or PR) assessed at the end of Cycles 1 and 3.\n\nAML: CR - free of all symptoms related to leukemia, absolute neutrophil count \\> 1.0 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, normal bone marrow with \\< 5% blasts no Auer rods; CRi - CR with residual thrombocytopenia (platelet count \\< 100 x 10\\^9/L) or residual neutropenia (absolute neutrophil count \\< 1.0 x 10\\^9/L); PR - A ≥ 50% decrease in bone marrow blasts to 5 to 25% abnormal.\n\nMDS or CMML: CR - free of all symptoms related to leukemia, absolute neutrophil count ≥ 1.0 x 10\\^9/L, platelet count ≥ 100 x 10\\^9/L, bone marrow ≤ 5% myeloblasts, w/ normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood; PR - All CR criteria with ≥50% decrease in bone marrow blasts over pre-treatment (but still \\> 5%); Marrow CR - In bone marrow, ≤ 5% myeloblasts and decrease by ≥ 50% over pre-treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia', 'Chronic Myelomonocytic Leukemia', 'Myelodysplastic Syndrome'], 'conditions': ['AML', 'CMML', 'MDS']}, 'referencesModule': {'references': [{'pmid': '32264726', 'type': 'DERIVED', 'citation': 'Garcia-Manero G, Pemmaraju N, Alvarado Y, Naqvi K, Ravandi F, Jabbour E, De Lumpa R, Kantarjian H, Advani A, Mukherjee S, Gerds A, Carraway HE, Nazha A, Iwamura H, Murase M, Bavisotto L, Kurman M, Maier G, Johansen M, Sekeres MA. Results of a Phase 1/2a dose-escalation study of FF-10501-01, an IMPDH inhibitor, in patients with acute myeloid leukemia or myelodysplastic syndromes. Leuk Lymphoma. 2020 Aug;61(8):1943-1953. doi: 10.1080/10428194.2020.1747065. Epub 2020 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML treated at the RP2D are planned, including MDS/CMML subjects treated at the RP2D in Phase 1.', 'detailedDescription': 'Subjects will receive FF-10501-01 orally on a twice daily schedule for 14, 21 or 28 days repeated every 28 days (=1 cycle). Disease assessments, including analysis of blood and bone marrow aspirates, will be performed at the end of Cycle 1 and every 2 cycles thereafter. Subjects who demonstrate objective response or stable disease will be allowed to continue therapy with FF-10501-01 until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in condition that prevent further study participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed advanced hematologic malignancies;\n\nPhase 1:\n\n* High-risk MDS/CMML (defined as ≥ 10% peripheral blood or marrow blasts and/or IPSS score ≥ 1.5) and relapsed or refractory to prior therapy\n* AML relapsed or refractory to prior therapy, or ≥ 60 years of age and not a candidate for other therapies\n\nPhase 2a:\n\n* MDS/CMML, relapsed from, or refractory to, prior HMA therapy; the latter defined as failure to achieve clinical remission (CR), partial remission (PR) or hematologic improvement (HI) after previous HMA therapy (≥ 4 cycles of azacitidine or decitabine), or progression during, or toxicity to previous HMA therapy precluding further HMA treatment, and,\n* Bone marrow blast count ≥ 10% or peripheral blast count ≥ 5%, or IPSS-R score ≥ 3.5.\n\n * At least 3 weeks beyond the last chemotherapy, targeted anticancer agent, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1). Hydroxyurea used to control peripheral blast counts is permitted up to Day 7 of treatment on study.\n * Adequate performance status: ECOG ≤ 2;\n * Adequate renal and hepatic function:\n* creatinine ≤ 2.0 mg/dL, or calculated creatinine clearance ≥ 45 mL/min\n* total bilirubin ≤ 2 times the upper limit of normal (ULN)\n* ALT/AST ≤ 2 times ULN\n\n * Negative serum pregnancy test\n * Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Known history of coronary artery disease, angina, myocardial infarction, congestive heart failure, cardiac arrhythmia or any other type of heart disease present within the last 6 months\n* Known family history of hereditary heart disease\n* QT interval corrected for rate (QTc) \\> 450 msec on the electrocardiogram (ECG) obtained at Screening\n* Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for the care of the patient.\n* Presence of active central nervous system (CNS) leukemia. Subjects adequately treated for CNS leukemia documented by 2 consecutive cerebrospinal fluid samples negative for leukemia cells are eligible. Subjects with no history of CNS leukemia will not be required to undergo cerebrospinal fluid sampling for eligibility.\n* Known positive for HIV, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).\n* Active infection requiring IV anti-infective usage within the last 7 days prior to study treatment.\n* Any other medical intervention or condition which could compromise adherence to study requirements or confound the interpretation of study results.\n* Pregnant or breast-feeding.\n* Treatment with any investigational product within 28 days prior to Screening.'}, 'identificationModule': {'nctId': 'NCT02193958', 'briefTitle': 'Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fujifilm Pharmaceuticals U.S.A., Inc.'}, 'officialTitle': 'A Phase 1/2a, Dose Escalation Study of FF-10501-01 for the Treatment of Advanced Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'FF1050101US01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 Cohort 1: 50mg/m2', 'description': 'FF-10501-01 tablets BID every 14 days of a 28-day cycle.', 'interventionNames': ['Drug: FF-10501-01']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 Cohort 2: 100mg/m2', 'description': 'FF-10501-01 tablets BID every 14 days of a 28-day cycle.', 'interventionNames': ['Drug: FF-10501-01']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 Cohort 3: 200mg/m2', 'description': 'FF-10501-01 tablets BID every 14 days of a 28-day cycle.', 'interventionNames': ['Drug: FF-10501-01']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 Cohort 4: 300mg/m2', 'description': 'FF-10501-01 tablets BID every 14 days of a 28-day cycle.', 'interventionNames': ['Drug: FF-10501-01']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 Cohort 5: 400mg/m2', 'description': 'FF-10501-01 tablets BID every 14 days of a 28-day cycle.', 'interventionNames': ['Drug: FF-10501-01']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 Cohort 6: 500mg/m2', 'description': 'FF-10501-01 tablets BID every 14 days of a 28-day cycle.', 'interventionNames': ['Drug: FF-10501-01']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a Cohort 7: 400mg/m2 in MDS/CMML', 'description': 'FF-10501-01 tablets BID every 21 days of a 28-day cycle.', 'interventionNames': ['Drug: FF-10501-01']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 Cohort 8: 400mg/m2', 'description': 'FF-10501-01 tablets BID every 28 days of a 28 day cycle.', 'interventionNames': ['Drug: FF-10501-01']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a Cohort 9: 400mg/m2', 'description': 'FF-10501-01 tablets BID every 21 days of a 28-day cycle.', 'interventionNames': ['Drug: FF-10501-01']}], 'interventions': [{'name': 'FF-10501-01', 'type': 'DRUG', 'otherNames': ['Single Group Assignment', 'Drug FF-10501-01'], 'description': 'FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6), Days 1-21 of a 28-say cycle (Cohort 7), Days 1-28 of a 28-day cycle (Cohort 8) or Days 1-21 of a 28-say cycle (Cohort 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.', 'armGroupLabels': ['Phase 1 Cohort 1: 50mg/m2', 'Phase 1 Cohort 2: 100mg/m2', 'Phase 1 Cohort 3: 200mg/m2', 'Phase 1 Cohort 4: 300mg/m2', 'Phase 1 Cohort 5: 400mg/m2', 'Phase 1 Cohort 6: 500mg/m2', 'Phase 1 Cohort 8: 400mg/m2', 'Phase 2a Cohort 7: 400mg/m2 in MDS/CMML', 'Phase 2a Cohort 9: 400mg/m2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic at Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Guillermo Garcia-Manero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujifilm Pharmaceuticals U.S.A., Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}