A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
The purpose of this study is to collect follow-up safety data from patients in completed abiraterone acetate studies. Consideration will be given to extending the duration of the study following review of the safety data at 3 years.
Metastatic Castration-resistant Prostate Cancer
Metastatic Breast Cancer
Drug: Abiraterone acetate
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study|
- The number of participants affected by a serious adverse event [ Time Frame: Up to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Abiraterone acetate
Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.
Drug: Abiraterone acetate
Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once dailyDrug: Abiraterone acetate
Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
This is a nonrandomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), long-term safety follow-up 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. This 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 low-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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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 will be 28 days. Investigators will monitor and assess the patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued treatment with abiraterone acetate is warranted. No efficacy data are being collected. Safety will be monitored throughout the study for a maximum duration of 3 years from the protocol issue date. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal. Consideration will be given to extending the duration of the study following review of the safety data at 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517802
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
Show 28 Study Locations
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|