{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4500"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"Maximum Tolerated Dose, defined as the dose level below which dose limiting toxicity (DLT) is manifested in ≥33% of the patients or at dose level 3 if DLT is manifested in \\<33% of the patients.","groups":[{"description":"Participants will receive intravenous infusions of APR-246 as a lead-in phase on days -14 to -11 starting at Dose Level 1 prior to starting cycle #1 of combination therapy with azacitidine. Combination therapy will consist of APR-246 on days 1-4 and azacitidine on days 4-10 (or days 4-5 and 8-12) of a 28 day cycle.\n\nAPR-246: Phase 1b: Dose escalation of APR-246 via intravenous (IV) infusion, with starting dose of 50 mg/kg lean body weight (LBW). Phase 2: APR-246 at maximum tolerated dose (MTD).\n\nAzacitidine: Azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m\\^2.","id":"OG000","title":"Phase 1b Dose Escalation"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 12 months","title":"Phase 1b: Maximum Tolerated Dose (MTD)","type":"PRIMARY","unitOfMeasure":"mg/day"}