NCT00474383

An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Cougar Biotechnology, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland \[a gland in the male reproductive system found below the bladder and in front of the rectum\] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.

Detailed description

This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with cancer who have failed taxane (docetaxel)-based chemotherapy. Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally (by mouth), once daily after an overnight fast until disease progression, lack of disease response after six 28-day cycles of treatment, or when unacceptable toxicity is encountered. Participants will be treated for up to 12 cycles. All participants will receive a concurrent low-dose glucocorticoid (such as prednisone 5 mg tablet twice daily/prednisolone 0.5 mg tablet once daily). Treatment will be continued in responding participants until death, or disease progression, or end of the study (which is Week 148). Efficacy will primarily be assessed through prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study. Participants who have completed 12 cycles of abiraterone acetate treatment, and continue to receive clinical benefit from such treatment, will be eligible to enter the extension study. Participants who enter the extension study will continue taking abiraterone acetate at the dose they were receiving at the end of the main study together with low-dose glucocorticoid. Efficacy and safety will be monitored throughout the extension study. Study treatment will end when the patient dies, is lost to follow-up, withdraws informed consent, experiences sustained side-effects, has disease progression, or the sponsor discontinues the extension study. After the end of study visit is completed for the extension study, participants will be followed every 12 weeks for survival for up to 3 years following entry into the extension study.

Conditions

• Prostate Neoplasms

Interventions

Type	Name	Description
DRUG	Abiraterone acetate	Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study.
DRUG	Glucocorticoid	Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study.

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2007-05-16
• Last updated: 2014-05-12
• Results posted: 2013-08-15

Locations

3 sites across 2 countries: United States, United Kingdom