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NCT00485303 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With 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
- 58
- Enrollment target
NCT00485303: Completed Phase 2 study, sponsored by Cougar Biotechnology.
NCT00485303 is a Phase 2 study that has completed, run by Cougar Biotechnology. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00485303, a Phase 2 study, has completed, sponsored by Cougar Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study 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).
Primary Outcome
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
Interventions
- DRUG Prednisone
- DRUG Abiraterone acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2007-06 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT00485303 record still lists
NCT00485303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Prednisone is the first listed.
NCT00485303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00485303 about?
NCT00485303 is a clinical study titled "An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy". 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).
What is the current status of trial NCT00485303?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2007-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00485303?
The interventions under investigation include: Prednisone (DRUG), Abiraterone acetate (DRUG).
Who is sponsoring clinical trial NCT00485303?
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 NCT00485303's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 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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