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NCT00630344 · ClinicalTrials.gov registry record · Phase 2
RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00630344: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00630344 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00630344, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
In the treatment of castration-resistant prostate cancer (CRPC), therapies will long response durations remain elusive as a result of the inherent ability of prostate cancer cells to develop iterative resistance. The goal of this study is to learn if the study drug RAD001 together with Bicalutamide can slow the growth of prostate cancer. The safety of the combination will also be studied.
Primary Outcome
Overall response rate is the percentage of patients achieving response taking into consideration measurable disease, bone metastases, and PSA. PSA declines in the absence of both measurable disease and the appearance of new bone lesions or a response in measurable disease without an increase in PSA or the appearance of new bone lesions. Patients with stable disease (SD) lasting at least 6 months will also be considered responders. Per RECIST guidelines, for target lesions, complete response (CR
Interventions
- DRUG Bicalutamide
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT00630344 record still lists
NCT00630344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Bicalutamide is the first listed.
NCT00630344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00630344 about?
NCT00630344 is a clinical study titled "RAD001 and Bicalutamide for Androgen Independent Prostate Cancer". In the treatment of castration-resistant prostate cancer (CRPC), therapies will long response durations remain elusive as a result of the inherent ability of prostate cancer cells to develop iterative resistance. The goal of this study is to learn if the study drug RAD001 together with Bicalutamide ...
What is the current status of trial NCT00630344?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2008-02. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00630344?
The interventions under investigation include: Bicalutamide (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT00630344?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00630344's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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