{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"}],"units":"Participants"}],"description":"Maximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which \\<33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy. This will define severe and delayed myelosuppression not related to persistent leukemia and likely related to treatment.","groups":[{"description":"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).","id":"OG000","title":"Phase I MTD Vosaroxin"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"21 days","title":"Maximum Tolerated Dose (MTD) of Vosaroxin in Combination With Decitabine","type":"PRIMARY","unitOfMeasure":"Mg/m^2"}