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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01517802
First received: January 23, 2012
Last updated: September 16, 2014
Last verified: September 2014

January 23, 2012
September 16, 2014
March 2012
April 2015   (final data collection date for primary outcome measure)
The number of participants affected by a serious adverse event [ Time Frame: Up to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
The number of participants affected by a serious adverse event [ Time Frame: Up to 30 days after the last dose of study drug or early withdrawal ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01517802 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

The purpose of this study is to collect follow-up safety data from patients in completed abiraterone acetate studies. Consideration will be given to extending the duration of the study following review of the safety data at 3 years.

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 Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible.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

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Castration-resistant Prostate Cancer
  • Metastatic Breast Cancer
  • Drug: Abiraterone acetate
    Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily
  • Drug: Abiraterone acetate
    Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
Experimental: Abiraterone acetate
Patients will continue the same treatment regimen they were receiving during their participation in the previous abiraterone acetate clinical study.
Interventions:
  • Drug: Abiraterone acetate
  • Drug: Abiraterone acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
United States,   Australia,   Belgium,   Germany,   Spain,   United Kingdom
 
NCT01517802
CR100797, 212082PCR3010, 2011-005243-28
No
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP