Status:
COMPLETED
A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Metastatic Castration-resistant Prostate Cancer
Metastatic Breast Cancer
Eligibility:
All Genders
Phase:
PHASE3
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 abira...
Eligibility Criteria
Inclusion
- Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.
Exclusion
- 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.
Key Trial Info
Start Date :
March 28 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01517802
Start Date
March 28 2012
End Date
April 22 2021
Last Update
May 10 2022
Active Locations (22)
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1
Aurora, Colorado, United States
2
Marrero, Louisiana, United States
3
Boston, Massachusetts, United States
4
Omaha, Nebraska, United States