{"groups":[{"description":"INCB053914 was self-administered orally once a day as a 100mg immediate release monotherapy dose.","id":"FG000","title":"Parts 1 and 2: INCB053914 100 mg QD"},{"description":"INCB053914 was self-administered orally twice day as a 50mg immediate release monotherapy dose.","id":"FG001","title":"Parts 1 and 2: INCB053914 50 mg BID"},{"description":"INCB053914 was self-administered orally twice day as a 65mg immediate release monotherapy dose.","id":"FG002","title":"Parts 1 and 2: INB053914 65 mg BID"},{"description":"INCB053914 was self-administered orally twice day as a 80mg immediate release monotherapy dose.","id":"FG003","title":"Parts 1 and 2: INB053914 80 mg BID"},{"description":"INCB053914 was self-administered orally twice day as a 100mg immediate release monotherapy dose.","id":"FG004","title":"Parts 1 and 2: INB053914 100 mg BID"},{"description":"INCB053914 was self-administered orally twice day as a 115mg immediate release monotherapy dose.","id":"FG005","title":"Parts 1 and 2: INB053914 115 mg BID"},{"description":"Combination Treatment Group A: 50 mg twice a day + I-DAC (intermediate dose cytarabine) was administered at a dose of 1 g/m2 as an infusion as a combination therapy with INCB053914.","id":"FG006","title":"Parts 3 and 4: INCB053914 50 mg BID + Cytarabine"},{"description":"Combination Treatment Group B: INCB053914 50 mg twice a day + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.","id":"FG007","title":"Parts 3 and 4: INCB053914 50 mg BID + Azacitidine"},{"description":"Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.","id":"FG008","title":"Part 3 and 4 - INCB053914 80 mg BID + Azacitidine"},{"description":"Combination Treatment Group C: INCB053914 50 mg + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.","id":"FG009","title":"Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib"},{"description":"Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.","id":"FG010","title":"Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"16"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"4"},{"groupId":"FG006","numSubjects":"6"},{"groupId":"FG007","numSubjects":"7"},{"groupId":"FG008","numSubjects":"9"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"6"}],"type":"Study Terminated by the Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"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"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Reason for study withdrawal not specified"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"2"}],"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":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"3"}],"type":"Physician Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"12"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"6"},{"groupId":"FG007","numSubjects":"7"},{"groupId":"FG008","numSubjects":"9"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"14"}],"type":"STARTED"},{"achievements":[{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG000","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG001","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG002","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG003","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG004","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG005","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG006","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG007","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG008","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG009","numSubjects":"0"},{"comment":"All participants discontinued study treatment and withdrew from the study.","groupId":"FG010","numSubjects":"0"}],"comment":"All participants in each arm discontinued study treatment and withdrew from the study.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"12"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"6"},{"groupId":"FG007","numSubjects":"7"},{"groupId":"FG008","numSubjects":"9"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 58 participants were enrolled and treated in Parts 1 and 2 combined and were included in the safety population and the full analysis set.\n\nA total of 39 participants enrolled and treated in Parts 3 and 4 combined were included in the safety population and the full analysis set.","recruitmentDetails":"This study was conducted in 18 US centers and consisted of 4 parts: Parts 1 and 2 evaluated INCB053914 as a monotherapy, and Parts 3 and 4 evaluated INCB053914 as part of a combination therapy with select standard-of-care agents (cytarabine, azacitidine, and ruxolitinib) in participants with advanced malignancies. Note:The study was terminated early based on strategic business decisions and not due to concerns with the safety and tolerability of INCB053914."}