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NCT00485485 · ClinicalTrials.gov registry record · Phase 2
Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT00485485: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00485485 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00485485, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Primary Objective: * To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration). Secondary Objectives: * To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer. * To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of Platelet-derived growth factor receptors (PDGF-R). * To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum. * To assess the rate of survival.
Primary Outcome
Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.
Interventions
- DRUG Docetaxel
- DRUG Imatinib Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2007-01 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00485485 record still lists
NCT00485485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT00485485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00485485 about?
NCT00485485 is a clinical study titled "Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer". Primary Objective: * To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration). Secondary Objectives: * To assess the safety and tolerability ...
What is the current status of trial NCT00485485?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2007-01. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00485485?
The interventions under investigation include: Docetaxel (DRUG), Imatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT00485485?
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 NCT00485485's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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