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NCT00474383 · ClinicalTrials.gov registry record · Phase 2
An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
A Phase 2 study, sponsored by Cougar Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT00474383: Completed Phase 2 study, sponsored by Cougar Biotechnology.
NCT00474383 is a Phase 2 study that has completed, run by Cougar Biotechnology. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00474383, a Phase 2 study, has completed, sponsored by Cougar Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study 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.
Primary Outcome
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Interventions
- DRUG Abiraterone acetate
- DRUG Glucocorticoid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2006-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT00474383 record still lists
NCT00474383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Abiraterone acetate is the first listed.
NCT00474383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00474383 about?
NCT00474383 is a clinical study titled "An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy". 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 s...
What is the current status of trial NCT00474383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2006-11. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00474383?
The interventions under investigation include: Abiraterone acetate (DRUG), Glucocorticoid (DRUG).
Who is sponsoring clinical trial NCT00474383?
This trial is sponsored by Cougar Biotechnology, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00474383's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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