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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00473005
The ClinicalTrials.gov registry entry for NCT00473005 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00473005 reports 0 study locations.
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.
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