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

Phase 3
Open (Enrolling)
Metastatic Castration-resistant Prostate Cancer, Metastatic Breast Cancer

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Trial Information

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

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 Patients can be withdrawn from the study if an alternative access (eg,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 3 years from the protocol issue date. End-of-study
assessments will be performed at least 30 days after the last dose of abiraterone or upon
early withdrawal. Consideration will be given to extending the duration of the study
following review of the safety data at 3 years.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The number of participants affected by a serious adverse event

Outcome Time Frame:

Up to 30 days after the last dose of study drug

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

July 2013

Related Keywords:

  • Metastatic Castration-Resistant Prostate Cancer
  • Metastatic Breast Cancer
  • Metastatic castration-resistant prostate cancer
  • Metastatic breast cancer
  • Abiraterone acetate
  • Low-dose corticosteroid treatment
  • Long-term access
  • Breast Neoplasms
  • Prostatic Neoplasms



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