Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473512
Status:
COMPLETED
Last Update Posted:
2014-03-27
First Post:
2007-05-11
Brief Title:
A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy
Sponsor:
Cougar Biotechnology Inc
Organization:
Cougar Biotechnology Inc
Study Overview
Official Title:
A Phase III Open Label Study of the 17α-Hydroxylase C1720 Lyase Inhibitor Abiraterone Acetate in Patients With Prostate Cancer Who Have Failed Hormone Therapy
Status:
COMPLETED
Status Verified Date:
2014-02
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 determine the maximum tolerated dose and evaluate the safety tolerability and activity at the recommended dose maximum tolerated dose MTD of abiraterone acetate also known as CB7630 in participants with hormone refractory prostate gland that makes fluid that aids movement of sperm cancer HRPC
Detailed Description:
This is an open-label all people know the identity of the intervention study to evaluate the safety tolerability and recommended dose of abiraterone acetate taken orally by mouth once daily in participants with HRPC The study will consist of a dose escalation stage Phase 1 that will be conducted to determine the MTD of abiraterone and an activity evaluation stage Phase 2 to evaluate the activity of abiraterone in participants with HRPC Escalated doses of abiraterone starting at 250 milligram mg up to a maximum of 2000 mg will be given for 28-day treatment periods to determine the MTD Participants will be given MTD of abiraterone for up to 12 cycles 28 day each in Phase 2 of the study 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 |
|---|---|---|---|
| COU-AA-001 | OTHER | Cougar Biotechnology | None |