{"classes":[{"categories":[{"measurements":[{"comment":"The maximum tolerated dose was not reached in the study","groupId":"OG000","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"}],"units":"Participants"}],"description":"Evaluation of three doses of opaganib - 250 mg bid, 500 mg bid and 750 mg bid to determine the maximum tolerated dose (MTD) based upon the dose limiting toxicity (DLT) using a Bayesian model averaging continual reassessment method and is the dose at which the estimated probability of toxicity is closest to the target probability 0.33 among all doses.","groups":[{"description":"Unblinded Phase 1b dose-finding study with dose escalation of study drug ABC294640. Once a subject was determined to be eligible for the study, the subject was enrolled in the dose escalation Phase 1b study testing ABC294640 at 250, 500 and 750 mg twice a day. A cycle of treatment was defined as 28 days and doses were given initially under fasting conditions. Subsequent to a food effect study, treatment was given after a light to moderate meal.","id":"OG000","title":"Opaganib"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"6 months","title":"Maximum Tolerated Dose","type":"PRIMARY","unitOfMeasure":"mg"}