{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"215"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"The MTD of crizotinib administered with combination chemotherapy based on the incidence of dose-limiting toxicity (DLT) at which fewer than one-third of patients experience DLT, as assessed by NCI CTCAE version 4.0.","groups":[{"description":"Patients receive crizotinib (capsule formulation) PO BID, cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Part C (Crizotinib, Cyclophosphamide, Topotecan Hydrochloride)"}],"paramType":"NUMBER","populationDescription":"Parts A, B and D MTD/RP2D were not assessed. As of Amendment #3, due to the possibility that many of the non-hematologic DLTs observed to date on the study are related to the palatability of the OS rather than due to true toxicity of the investigational agent, Parts A and B were closed and Part C was then opened to determine the MTD/ RP2D. As of Amendment #4, a new microsphere formulation was added for Part D, but there was no MTD/RP2D.","reportingStatus":"POSTED","timeFrame":"Up to 21 days","title":"Maximum Tolerated Dose (MTD) of Crizotinib","type":"PRIMARY","unitOfMeasure":"mg/m^2"}