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A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration-Resistant Prostate Cancer Patients Who Have Received Docetaxel-based Chemotherapy
The purpose of this study is to investigate the safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) who have received docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents).
This is a multi-center (conducted in more than one center), open-label (all people know the identity of the intervention), single-arm study to investigate safety and efficacy of abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein abiraterone 1000 milligram \[mg\] once daily and 5 mg prednisolone twice daily will be given until disease progression or unacceptable toxicity is observed); and Follow-up phase (up to 5 years or until survival after the first dose of study drug). Abiraterone will be administered orally daily as at least 1 hour before the meal or 2 hours after the meal. Dose reduction will be allowed at the Investigator's discretion but not lower than 500 mg per day. Participants will discontinue study treatment at disease progression unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of therapy. Participants' safety will be monitored throughout the study.
Age
20 - No limit years
Sex
MALE
Healthy Volunteers
No
Asahi, Japan
Fukuoka, Japan
Kanazawa, Japan
Kita-Gun, Japan
Kukichūō, Japan
Kurashiki, Japan
Maebashi, Japan
Matsuyama, Japan
Mitaka, Japan
Niigata, Japan
Start Date
June 1, 2012
Primary Completion Date
October 1, 2014
Completion Date
October 1, 2014
Last Updated
November 4, 2015
47
ACTUAL participants
Abiraterone
DRUG
Prednisolone
DRUG
Lead Sponsor
Janssen Research & Development, LLC
NCT04550494
NCT05691465
Data Source & Attribution
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