drugset / Trial / NCT01717898

A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer

NCT01717898

Phase 1/2 Terminated 6 enrolled Charles Ryan Novartis Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

Summary

There will be two parts to this clinical research study. The purpose of each part is: * Phase 1: This part of the study will determine what dose of BEZ235 is safe to give with a standard dose of abiraterone acetate and prednisone by administering different doses of BEZ235. This will help to find out what effects, good and/or bad, this combination has on CRPC. * Phase 2: This part of the study will measure the treatment effect of the combination of BEZ235 and abiraterone acetate/prednisone on CRPC.

Timeline

Start
2013-01-31
Primary completion
2013-09-03
Completion
2016-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Dactolisib Small molecule 200 mg Oral
Subject Dactolisib Small molecule 300 mg Oral
Subject Dactolisib Small molecule 400 mg Oral
Background Abiraterone acetate Small molecule 1000 mg Oral
Background Prednisone Other / unclassified 10 mg Oral