{"classes":[{"categories":[{"measurements":[{"comment":"Since the minimum number of subjects needed to evaluate MTD were not enrolled, the MTD could not be determined.","groupId":"OG000","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"MTD is the dose level with a model-estimated rate of Dose Limiting Toxicities (DLT) closest to 25% after 36 patients have been enrolled.\n\nThe maximum tolerated dose could not be determined because the trial was terminated early, however the number of participants who experienced DLTs found at each dose level is reported in a new outcome measure.","groups":[{"description":"Romidepsin dose of either 10mg/m², 14mg/m² IV on days 1, 8, 15, or 14mg/m² on days 1 and 8 : Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.\n\nIxazomib 4 mg PO on days 1, 8, 15: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.","id":"OG000","title":"All Subjects Treated"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From first dose of treatment through the 1st cycle (28 days)","title":"Phase I: Maximum Tolerated Dose (MTD)","type":"PRIMARY","unitOfMeasure":"mg/m^2"}