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

April 20, 2022 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Kogarah, Australia
      • Kurralta Park, Australia
      • South Brisbane, Australia
      • Subiaco, Australia
  • Belgium
      • Antwerpen, Belgium
  • Germany
      • Hamburg, Germany
  • Spain
      • Barcelona, Spain
  • Sweden
      • Uppsala, Sweden
  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Northwood, United Kingdom
      • Sutton, United Kingdom
      • Whitchurch, United Kingdom
  • United States
    • Colorado
      • Aurora, Colorado, United States
    • Louisiana
      • Marrero, Louisiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • East Setauket, New York, United States
      • New York, New York, United States
    • South Carolina
      • Myrtle Beach, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 daily
Drug: Prednisone
Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to 9 years
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.
Up to 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2012

Primary Completion (Actual)

April 22, 2021

Study Completion (Actual)

April 22, 2021

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 23, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Actual)

May 10, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100797
  • 212082PCR3010 (Other Identifier: Janssen Research & Development, LLC)
  • 2011-005243-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Breast Cancer

Clinical Trials on Abiraterone acetate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe