NCT02300610View on ClinicalTrials.gov

Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

February 11, 2015

Primary Completion Date

August 7, 2017

Study Completion Date

April 19, 2019

Conditions
Bladder CancerCarcinoma, Transitional CellRenal Pelvis CancerUreter CancerUrethra Cancer
Interventions
DRUG

Enzalutamide

Enzalutamide orally once a day. Dose Escalation Level 1: 80 mg; Level 2: 160 mg. Dose Expansion at recommended dose level, after dose escalation.

DRUG

Cisplatin

Cisplatin at 70 mg/m\^2 IV on day 1, repeated every 21 days for total of 6 cycles.

DRUG

Gemcitabine

Gemcitabine at 1000 mg/m\^2 IV on days 1, 8, repeated every 21 days for total of 6 cycles.

Trial Locations (2)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

55455

University of Minnesota, Masonic Cancer Center, Minneapolis

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT02300610 - Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer | Biotech Hunter | Biotech Hunter