Phase Ib Dose Finding Study of Abiraterone Acetate Plus BEZ235 or BKM120 in Patients With Castration-resistant Prostate Cancer.
A dose-escalation part will first determine the maximum tolerated dose (MTD) and/or
recomended dose for expansion (RDE) of abiraterone acetate in combination with BEZ235 and
abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate
failure.
Subsequently, the MTD and/or RDE of each combination will be investigated in two expansion
treatment groups of CRPC patients who have failed abiraterone acetate therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of dose limiting toxicities (DLTs)
Dose escalation part: Determine MTD and /or RDE of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of DLTs in cycle 1
from days 8-35 in BEZ235/abiraterone acetate arm and from days 0-28 in BKM120/abiraterone acetate arm
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Belgium: Federal Agency for Medicinal Products and Health Products
CBEZ235D2101
NCT01634061
September 2012
April 2015
Name | Location |
---|---|
Horizon Oncology Center Horizon Onc | Lafayette, Indiana 47905 |
Cedars Sinai Medical Center SC | Los Angeles, California 90048 |
Hackensack University Medical Center Hackensack Univ | Hackensack, New Jersey 07601 |
H. Lee Moffitt Cancer Center/University of South Florida Dept of Onc | Tampa, Florida 33612 |
University of Michigan Comprehensive Cancer Center Dept of Oncology | Ann Arbor, Michigan 48109-0944 |
NYU Langone Medical Center Clinical Cancer Center | New York, New York 10016 |
Memorial Hermann/Memorial City Hospital University of Texas | Houston, Texas 77024 |