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NCT00253318 · ClinicalTrials.gov registry record · Phase 1
RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00253318: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00253318 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00253318, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Primary: * To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I). * To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase I). Secondary: * To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel * To determine the effect of the combination of RAD001 and docetaxel on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination
Interventions
- DRUG Docetaxel
- DRUG Dexamethasone
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2005-11-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00253318
The ClinicalTrials.gov registry entry for NCT00253318 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00253318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00253318 about?
NCT00253318 is a clinical study titled "RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer". Primary: * To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I). * To characterize the pharmaco...
What is the current status of trial NCT00253318?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2005-11-01. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00253318?
The interventions under investigation include: Docetaxel (DRUG), Dexamethasone (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT00253318?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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