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NCT00459186 · ClinicalTrials.gov registry record · Phase 1
The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00459186: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT00459186 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00459186, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I). Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (Phase II).
Primary Outcome
A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria: Hematologic Toxicity: CTCAE grade 4 neutropenia \> 7 days or any Grade 3 or 4 neutropenia with fever Or CTCAE grade 3 or 4 thrombocytopenia \> 7 days Non-hematologic toxicity: The oc
Interventions
- DRUG Docetaxel
- DRUG Prednisone
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2005-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT00459186 record still lists
NCT00459186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00459186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00459186 about?
NCT00459186 is a clinical study titled "The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer". The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I). Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (P...
What is the current status of trial NCT00459186?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2005-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00459186?
The interventions under investigation include: Docetaxel (DRUG), Prednisone (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT00459186?
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 NCT00459186's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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