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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). 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 |
Why NCT00253318 stopped before completion
NCT00253318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00253318 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00253318's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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