{"denoms":[{"counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"7"},{"groupId":"BG008","value":"17"},{"groupId":"BG009","value":"55"}],"units":"Participants"}],"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":"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 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 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":"BG006","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":"BG007","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":"BG008","title":"Phase 2a Cohort 9: 400mg/m2"},{"description":"Total of all reporting groups","id":"BG009","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"2"},{"groupId":"BG008","value":"1"},{"groupId":"BG009","value":"8"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"5"},{"groupId":"BG008","value":"16"},{"groupId":"BG009","value":"47"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"4.04","value":"73.67"},{"groupId":"BG001","spread":"11.79","value":"69.00"},{"groupId":"BG002","spread":"9.36","value":"66.25"},{"groupId":"BG003","spread":"5.35","value":"76.00"},{"groupId":"BG004","spread":"5.72","value":"79.00"},{"groupId":"BG005","spread":"9.14","value":"71.00"},{"groupId":"BG006","spread":"3.78","value":"77.40"},{"groupId":"BG007","spread":"9.36","value":"73.29"},{"groupId":"BG008","spread":"6.68","value":"73.00"},{"groupId":"BG009","spread":"7.355","value":"73.44"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"3"},{"groupId":"BG006","value":"2"},{"groupId":"BG007","value":"4"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"21"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"2"},{"groupId":"BG006","value":"3"},{"groupId":"BG007","value":"3"},{"groupId":"BG008","value":"14"},{"groupId":"BG009","value":"34"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"5"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"3"},{"groupId":"BG007","value":"7"},{"groupId":"BG008","value":"14"},{"groupId":"BG009","value":"41"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"9"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"1"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"4"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"6"},{"groupId":"BG008","value":"16"},{"groupId":"BG009","value":"49"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"1"},{"groupId":"BG009","value":"2"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"7"},{"groupId":"BG008","value":"17"},{"groupId":"BG009","value":"55"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]}