{"groups":[{"description":"Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"FG000","title":"Phase 1 Dose Escalation Cohort 1"},{"description":"Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"FG001","title":"Phase 1 Dose Escalation Cohort 2"},{"description":"Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"FG002","title":"Phase 1 Dose Escalation Cohort 3"},{"description":"Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"FG003","title":"Phase 1 Dose Escalation Cohort 4"},{"description":"Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).","id":"FG004","title":"Phase 1 Dose Escalation Cohort 5"},{"description":"Participants were randomized in a 1:1 ratio to receive oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\\^2) Dailyx5 in Course 2 (28 days per course) in Sequence A. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.","id":"FG005","title":"Phase 2 Dose Confirmation Sequence A"},{"description":"Participants were randomized in a 1:1 ratio to receive IV decibatine (20 mg/m\\^2) Dailyx5 in Course 1 followed by oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 2 (28 days per course) in Sequence B. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.","id":"FG006","title":"Phase 2 Dose Confirmation Sequence B"},{"description":"Participants were randomized in a 1:1 ratio to receive oral cedazuridine (100 mg) + decitabine (35 mg) tablets Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\\^2) Dailyx5 in Course 2 (28 days per course) in Sequence A. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.","id":"FG007","title":"Phase 2 Fixed-Dose Combination Sequence A"},{"description":"Participants were randomized in a 1:1 ratio to receive IV decibatine (20 mg/m\\^2) Dailyx5 in Course 1 followed by oral cedazuridine (100 mg) + decitabine (35 mg) tablets Dailyx5 in Course 2 (28 days per course) in Sequence B. In Courses ≥ 3, all participants received cedazuridine and decitabine Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.","id":"FG008","title":"Phase 2 Fixed-Dose Combination Sequence B"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"5"},{"groupId":"FG005","numSubjects":"15"},{"groupId":"FG006","numSubjects":"14"},{"groupId":"FG007","numSubjects":"10"},{"groupId":"FG008","numSubjects":"11"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"1"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"0"}],"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":"1"},{"groupId":"FG008","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"8"},{"groupId":"FG006","numSubjects":"8"},{"groupId":"FG007","numSubjects":"4"},{"groupId":"FG008","numSubjects":"2"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"19"},{"groupId":"FG005","numSubjects":"25"},{"groupId":"FG006","numSubjects":"25"},{"groupId":"FG007","numSubjects":"16"},{"groupId":"FG008","numSubjects":"14"}],"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"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"19"},{"groupId":"FG005","numSubjects":"25"},{"groupId":"FG006","numSubjects":"25"},{"groupId":"FG007","numSubjects":"16"},{"groupId":"FG008","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Response data for Phase 1 per June 2017 data cut and for Phase 2 per June 2018 data cut. Median follow up in Phase 1 was 1915.5 days (range: 1771-2213) and 1563.0 days in Phase 2 (range: 1199-1710).","recruitmentDetails":"In Phase 1, 127 participants were screened and 44 were randomized and received at least one treatment. In Phase 2, a total of 138 were screened, 86 were randomized, and 80 received at least one treatment."}