{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"160"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"Dose Escalation. Maximum Tolerated Dose (MTD) of Enzalutamide when given with Cisplatin and Gemcitabine at standard doses. Dose Level 1: 80 mg Enzalutamide; Dose Level 2: 160 mg Enzalutamide.\n\nDose-Limiting Toxicity (DLT) is defined as any of the following occurring in the first 21 days (cycle 1) of study participation that are considered at least possibly related to enzalutamide administration. Toxicities that are in the opinion of the investigator(s) attributable exclusively to gemcitabine or cisplatin will not be considered DLT.\n\n* 7 consecutive missed doses (out of 21 doses) of enzalutamide in 21 days due to study drug related toxicity.\n* Missed day 8 dose of gemcitabine in cycle 1 will not be considered DLT.\n* Delay of greater than 3 weeks from scheduled date in initiating cycle 2 due to study drug related toxicity.\n* Discontinuation of a patient due to study drug related toxicity before completing cycle 1.","groups":[{"description":"Dose Escalation: Begin with Level 1 dose of enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).","id":"OG000","title":"Dose Escalation"}],"paramType":"NUMBER","populationDescription":"All participants in Dose Escalation arm.","reportingStatus":"POSTED","timeFrame":"Up to 6 months","title":"Recommended Dose of Enzalutamide","type":"PRIMARY","unitOfMeasure":"mg"}