Spots Global Cancer Trial Database for Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients
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Trial Identification
Brief Title: Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients
Official Title: Phase Ib Dose Finding Study of Abiraterone Acetate Plus BEZ235 or BKM120 in Patients With Castration-resistant Prostate Cancer.
Study ID: NCT01634061
Conditions
Study Description
Brief Summary: This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Cedars Sinai Medical Center SC, Los Angeles, California, United States
Hackensack University Medical Center Hackensack Univ, Hackensack, New Jersey, United States
Novartis Investigative Site, Brussels, , Belgium
Novartis Investigative Site, Wilrijk, , Belgium
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Marseille, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Sutton, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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