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ACTIVE NOT RECRUITING
NCT02123758
PHASE1

A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer

Sponsor: Aragon Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

DRUG

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).

DRUG

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).

DRUG

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