{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}],"title":"Partial Response subjects"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}],"title":"Complete bone marrow remission (mCR)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"5"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"17"}],"units":"Participants"}],"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.","groups":[{"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":"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 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 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":"OG006","title":"Phase 1 Cohort 7: 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":"OG007","title":"Phase 1 Cohort 8: 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":"OG008","title":"Phase 2a Cohort 9: 400mg/m2"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"OR responses were assessed at end of Cycles 1 thru 3. Each cycle was 28 days in length.","title":"Determination of Objective Response (OR) Rates.","type":"SECONDARY","unitOfMeasure":"participants"}