NCT01692483

Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Janssen Pharmaceutica · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane.

Detailed description

This is an open-label (identity of assigned study drug will be known), observational study to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic CRPC who have received prior chemotherapy containing a taxane. Approximately 50 patients will be enrolled. Abiraterone acetate will be administered according to the approved product insert with a low-dose glucocorticoid (prednisone or prednisolone). Patient assessments will be based on the accepted clinical practice in the Philippines. Patients will be monitored for 40 weeks.

Conditions

• Prostate Neoplasms

Interventions

Type	Name	Description
DRUG	Abiraterone acetate	Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
DRUG	Prednisone	Prednisone or prednisolone 5 mg tablet taken orally twice daily

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2012-09-25
• Last updated: 2015-12-02