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

NCT ID: NCT01517802

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-28
• Study Completion Date: 2021-04-22

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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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

Conditions

Metastatic Castration-resistant Prostate Cancer; Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abiraterone acetate

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

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

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

Interventions

Abiraterone acetate

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

Intervention Type: DRUG

Prednisone

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

Intervention Type: DRUG

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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

Antwerp, , Belgium

Hamburg, , Germany

Barcelona, , Spain

Uppsala, , Sweden

Newcastle upon Tyne, , United Kingdom

Northwood, , United Kingdom

Sutton, , United Kingdom

Whitchurch, , United Kingdom

Countries

United States; Australia; Belgium; Germany; Spain; Sweden; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

212082PCR3010

Identifier Type: OTHER

Identifier Source: secondary_id

2011-005243-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100797

Identifier Type: -

Identifier Source: org_study_id