drugset / Trial / NCT01717898
A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |