{"denoms":[{"counts":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"66"}],"units":"Participants"}],"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":"BG000","title":"Phase I MTD Vosaroxin"},{"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).\n\nFollowing the phase I portion, patients in phase II receive the following induction:\n\n1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.\n2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.\n\nVosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.\n\nPhase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.\n\nDecitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).","id":"BG001","title":"Vosaroxin + Decitabine"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"11"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"55"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"41","upperLimit":"75","value":"69"},{"groupId":"BG001","lowerLimit":"60","upperLimit":"78","value":"69"},{"groupId":"BG002","lowerLimit":"41","upperLimit":"78","value":"69"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"24"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"42"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"56"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"66"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]}