Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Castration-resistant Prostate Cancer
Interventions
DRUG

BEZ235

BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.

DRUG

BKM120

BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.

DRUG

BEZ235

BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.

DRUG

BKM120

BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.

Trial Locations (10)

2610

Novartis Investigative Site, Wilrijk

13273

Novartis Investigative Site, Marseille

28041

Novartis Investigative Site, Madrid

90048

Cedars Sinai Medical Center SC, Los Angeles

94805

Novartis Investigative Site, Villejuif

07601

Hackensack University Medical Center Hackensack Univ, Hackensack

BE-B-1200

Novartis Investigative Site, Brussels

V5Z 4E6

Novartis Investigative Site, Vancouver

08036

Novartis Investigative Site, Barcelona

SM2 5PT

Novartis Investigative Site, Sutton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY