{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"}],"units":"Participants"}],"description":"MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants.","groups":[{"description":"Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).","id":"OG000","title":"Alisertib"}],"paramType":"NUMBER","populationDescription":"DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug to 30 days after the last dose (up to 422 days)","title":"Maximum Tolerated Dose (MTD) of Alisertib","type":"PRIMARY","unitOfMeasure":"mg BID for 7 days"}