Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474383
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2007-05-14
Brief Title:
An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced 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 in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2014-04
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 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 dailyprednisolone 05 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
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 |
|---|---|---|---|
| NCT01798615 | OTHER | ClinicalTrialsgov Identifier | None |
| COU-AA-003 | None | None | None |
| COU-AA-003EXT | None | None | None |