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NCT00473005 · ClinicalTrials.gov registry record · Phase 1
Phase I Oral mTOR Inhibitor RAD001 in Combo w/ Capecitabine for Metastatic Breast
A Phase 1 study, sponsored by Stanford University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00473005: Clinical Trial Phase 1 study, sponsored by Stanford University.
NCT00473005 is a Phase 1 study that was terminated before completion, run by Stanford University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00473005, a Phase 1 study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
In order to improve the survival of metastatic breast patients, it is important to investigate the use of novel therapeutic agents combined with known active agents in the treatment of breast cancer. This is a phase I study evaluating the maximum tolerated doses and toxicities of RAD001 in combination with capecitabine for the treatment of metastatic breast cancer. RAD001 (INN: everolimus) is a novel macrolide, which is being developed as an antiproliferative drug with applications as an immunosuppressant and anticancer agent. Phase I trials in patients with solid tumors have shown that treatment with RAD001 is well-tolerated with a minimal side effect profile. Capecitabine (Xeloda, Roche) is an oral fluoropyrimidine that was approved in 1998 for the treatment of patients with metastatic breast cancer. The all-oral regimen of RAD001 with capecitabine is an attractive approach as the treatment of metastatic breast cancer has not yet proven to be curative. We also want to find out what possible benefit this combination of drugs might have on treating your cancer.
Interventions
- DRUG Capecitabine
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
Why NCT00473005 stopped before completion
NCT00473005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00473005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00473005 about?
NCT00473005 is a clinical study titled "Phase I Oral mTOR Inhibitor RAD001 in Combo w/ Capecitabine for Metastatic Breast". In order to improve the survival of metastatic breast patients, it is important to investigate the use of novel therapeutic agents combined with known active agents in the treatment of breast cancer. This is a phase I study evaluating the maximum tolerated doses and toxicities of RAD001 in combinati...
What is the current status of trial NCT00473005?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2007-08. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00473005?
The interventions under investigation include: Capecitabine (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT00473005?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00473005's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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