{"groups":[{"description":"Duvelisib was administered orally (PO) twice daily (BID) at a starting dose of 25 milligrams (mg), with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.","id":"FG000","title":"Dose Optimization Phase: Cohort 1"},{"description":"Duvelisib 75 mg PO BID was administered in 28-day cycles.","id":"FG001","title":"Dose Optimization Phase: Cohort 2"},{"description":"Duvelisib PO BID at a starting dose of 75 mg was administered for the first 2 cycles (28-day cycles), followed by a mandatory reduction to 25 mg BID thereafter for those participants with complete response (CR), partial response (PR) or stable disease (SD), in 28-day cycles (dose determined in Optimization Phase).","id":"FG002","title":"Expansion Phase"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Closure Of The Study By The Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Safety Analysis Set; Modified Intent-to-treat (mITT)","type":"Received at Least 1 Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Dose Optimization Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"39"}],"type":"Closure Of The Study By The Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"78"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"comment":"Participants enrolled for Expansion Phase only.","groupId":"FG002","numSubjects":"123"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"123"}],"comment":"Safety Analysis Set; Modified Intent-to-treat (mITT)","type":"Received at Least 1 Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"123"}],"type":"NOT COMPLETED"}],"title":"Expansion Phase"}],"recruitmentDetails":"Regardless of study phase, all participants underwent screening assessments up to 30 days before the first study drug dose."}