Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485303
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2007-06-08
Brief Title:
An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Sponsor:
Cougar Biotechnology Inc
Organization:
Cougar Biotechnology Inc
Study Overview
Official Title:
A Phase II Open Label Study of CB7630 Abiraterone Acetate and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably forming tumors
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 prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram mg orally by mouth once daily after an overnight fast and prednisoneprednisolone will be administered as 5 mg oral tablet twice daily Participants will be enrolled and treated up to 12 cycles or longer if they have not progressed and continue to benefit from treatment The study will consist of 3 parts Screening 14 days Open-label Treatment and follow-up up to 60 months Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group PSAWG criteria Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-002725-74 | EUDRACT_NUMBER | None | None |
| COU-AA-004 | None | None | None |