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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

September 3, 2013

Study Completion Date

August 29, 2016

Conditions
Castrate-resistant Prostate Cancer
Interventions
DRUG

BEZ235

BEZ235 - 200 mg, 300 mg, or 400 mg; po, BID. BEZ235 will be supplied in 200 mg, 300 mg, and 400 mg sachets packaged in boxes.

DRUG

Prednisone

10/mg po daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.

DRUG

Abiraterone acetate

1000 mg, po. Abiraterone Acetate is supplied in 250 mg white tablets, four tablets are to be taken with a full glass of water on an empty stomach once daily.

Trial Locations (1)

94115

University of California, San Francisco, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Charles Ryan

OTHER