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A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Sponsor: Aragon Pharmaceuticals, Inc.
Summary
The purpose of this study is to investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine safety of the combination and evaluate in a descriptive manner the efficacy in these participants. It will also, potentially provide dosing recommendations for abiraterone acetate in future studies when combined with JNJ-56021927.
Official title: A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2014-07-09
Completion Date
2027-12-31
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Abiraterone Acetate
Administered orally (by mouth) once daily in morning at a dose of 1000 mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
Prednisone
Administered orally twice a day at a dose of 5mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
JNJ-56021927
Administered orally once daily in morning at a dose of 240 mg starting on Day 8, Treatment Cycle 1 for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
Locations (7)
Los Angeles, California, United States
San Francisco, California, United States
Houston, Texas, United States
Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Rotterdam, Netherlands
Sutton, United Kingdom