{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"comment":"The MTD for schedule B was not reached because no DLTs were observed for schedule B.","groupId":"OG001","value":"NA"}]}],"title":"Pralatrexate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"comment":"The MTD for schedule B was not reached because no DLTs were observed for schedule B.","groupId":"OG001","value":"NA"}]}],"title":"Romidepsin"}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"The MTD was defined as the dose level at which one-third or fewer patients experienced a dose limiting toxicity. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.","groups":[{"description":"Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 8 of each 21-day cycle.","id":"OG000","title":"Phase I: Schedule A"},{"description":"Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 15 of each 28-day cycle.","id":"OG001","title":"Phase I: Schedule B"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 1.5 years","title":"Maximum Tolerated Dose (MTD) of the Combination of Pralatrexate and Romidepsin in Phase 1","type":"PRIMARY","unitOfMeasure":"mg/m2"}