{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"300"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.","groups":[{"description":"Phase I, Arm A (VR-DA-EPOCH)","id":"OG000","title":"Phase I: VR-DA-EPOCH"}],"paramType":"NUMBER","populationDescription":"Eligible Phase I Arm A (VR-DA-EPOCH) participants who completed at least 1 cycle of treatment. This arm includes participants treated at 300 mg once a day (n=6) or 400 mg once a day (n=6) of Vorinostat for days 1-5.","reportingStatus":"POSTED","timeFrame":"21 days","title":"Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)","type":"PRIMARY","unitOfMeasure":"Mg per day of Vorinostat"}