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

A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study

Sponsors

Lead Sponsor: Janssen Research & Development, LLC

Source Janssen Research & Development, LLC
Brief 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.

Detailed 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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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.

Overall Status Active, not recruiting
Start Date March 28, 2012
Completion Date April 9, 2021
Primary Completion Date April 9, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
The number of participants affected by a serious adverse event Up to 30 days after the last dose of study drug
Enrollment 32
Condition
Intervention

Intervention Type: Drug

Intervention Name: Abiraterone acetate

Description: Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily

Arm Group Label: Abiraterone acetate

Intervention Type: Drug

Intervention Name: Prednisone

Description: Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily

Arm Group Label: Abiraterone acetate

Eligibility

Criteria:

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.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Location
Facility:
| Aurora, Colorado, United States
| Marrero, Louisiana, United States
| Boston, Massachusetts, United States
| Omaha, Nebraska, United States
| East Setauket, New York, United States
| New York, New York, United States
| Myrtle Beach, South Carolina, United States
| Chattanooga, Tennessee, United States
| Dallas, Texas, United States
| Houston, Texas, United States
| Kogarah, Australia
| Kurralta Park, Australia
| South Brisbane, Australia
| Subiaco, Australia
| Antwerpen, Belgium
| Hamburg, Germany
| Barcelona, Spain
| Uppsala, Sweden
| Newcastle Upon Tyne, United Kingdom
| Northwood, United Kingdom
| Sutton, United Kingdom
| Whitchurch, United Kingdom
Location Countries

Australia

Belgium

Germany

Spain

Sweden

United Kingdom

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Abiraterone acetate

Type: Experimental

Description: Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov