{"classes":[{"categories":[{"measurements":[{"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"}]}],"title":"Any TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"14"}]}],"title":"Any study drug related TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"11"}]}],"title":"Any serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"15"}]}],"title":"Grade 3 or 4 TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"6"}]}],"title":"Grade 3 or 4 study drug related TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"7"}]}],"title":"Interruption of study drug due to TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"0"}]}],"title":"Death due to TEAEs"}],"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":"Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity","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":"12 months","title":"Safety Assessed by Adverse Events","type":"PRIMARY","unitOfMeasure":"participants"}