Open Label Abiraterone Acetate Long Term Access Study (JNJ-212082)
Research type
Research Study
Full title
A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Access Study
IRAS ID
100749
Contact name
Johann De-Bono
Sponsor organisation
Janssen Cilag International N.V.
Eudract number
2011-005243-28
Clinicaltrials.gov Identifier
Research summary
This study is being conducted on behalf of Janssen Research & Development. This is a non-randomised (individuals will not be assigned by chance to study treatments), open-label (individuals know the identity of study treatments) long term access study of abiraterone acetate in approximately 300 patients from other completed abiraterone acetate clinical studies. Patients must have received at least 3 months of treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator assessment, may benefit from continued treatment. Abiraterone acetate is a nonselective irreversible inhibitor of the enzyme cytochrome P450 CYP17. Inhibition of this enzyme decreases circulating levels of testosterone from the testes, adrenal glands and the tumour itself. Abiraterone acetate has received marketing approval in the US, EU, Canada, Brazil, and Switzerland for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) after docetaxal (chemotherapy) treatment. It is also being investigated for the treatment of mCRPC in men who have not previously received chemotherapy for mCRPC. The study will consist of a screening period followed by open-label treatment of continued abiraterone acetate access. The patients will continue with the same abiraterone acetate and lot dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate clinical study until the investigator determines that the patient is no longer receiving benefit or the Sponsor terminates the study. Patients can be withdrawn from the study if an alternative access (eg, patient assistance program or commercial source of abiraterone acetate) is available and feasible. Each cycle of treatment is 28 days. Investigators will monitor and assess patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued teatment is warranted. No efficacy data is being collected. Safety will be monitored throughout the study. End-of-study assessments will be performed at least 30 days after the last dose.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
12/LO/0434
Date of REC Opinion
14 Jun 2012
REC opinion
Favourable Opinion