Overview

This trial is active, not recruiting.

Conditions metastatic castration-resistant prostate cancer, metastatic breast cancer
Treatments abiraterone acetate, prednisone
Phase phase 3
Sponsor Janssen Research & Development, LLC
Start date March 2012
End date April 2018
Trial size 30 participants
Trial identifier NCT01517802, 2011-005243-28, 212082PCR3010, CR100797

Summary

The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 6 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.
abiraterone acetate
Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily
prednisone
Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily

Primary Outcomes

Measure
The number of participants affected by a serious adverse event
time frame: Up to 30 days after the last dose of study drug

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets. Exclusion Criteria: - Medical conditions that require hospitalization. - Any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.

Additional Information

Official title A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study
Description 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 6 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.