A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Metastatic Breast Cancer

Metastatic Castration-resistant Prostate Cancer

Treatments

Drug: Abiraterone acetate

Drug: Prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01517802

CR100797

212082PCR3010 (Other Identifier)

2011-005243-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.

Full 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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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 9 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.

Enrollment

32 patients

Sex

All

Volunteers

No Healthy Volunteers

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.