A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
This trial is active, not recruiting.
|Conditions||metastatic castration-resistant prostate cancer, metastatic breast cancer|
|Treatments||abiraterone acetate, prednisone|
|Sponsor||Janssen Research & Development, LLC|
|Start date||March 2012|
|End date||April 2018|
|Trial size||30 participants|
|Trial identifier||NCT01517802, 2011-005243-28, 212082PCR3010, CR100797|
The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 6 years.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Aurora, CO||not available||no longer recruiting|
|Marrero, LA||not available||no longer recruiting|
|Boston, MA||not available||no longer recruiting|
|Omaha, NE||not available||no longer recruiting|
|East Setauket, NY||not available||no longer recruiting|
|New York, NY||not available||no longer recruiting|
|Myrtle Beach, SC||not available||no longer recruiting|
|Chattanooga, TN||not available||no longer recruiting|
|Dallas, TX||not available||no longer recruiting|
|Houston, TX||not available||no longer recruiting|
|Kogarah, Australia||not available||no longer recruiting|
|South Brisbane, Australia||not available||no longer recruiting|
|Antwerpen, Belgium||not available||no longer recruiting|
|Hamburg, Germany||not available||no longer recruiting|
|Barcelona, Spain||not available||no longer recruiting|
|Newcastle Upon Tyne, United Kingdom||not available||no longer recruiting|
|Northwood, United Kingdom||not available||no longer recruiting|
|Sutton, United Kingdom||not available||no longer recruiting|
|Whitchurch, United Kingdom||not available||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
The number of participants affected by a serious adverse event
time frame: Up to 30 days after the last dose of study drug
Male or female participants of any age.
- Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.
- 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.
|Official title||A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study|
|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 6 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.|
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