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NCT00506779 · ClinicalTrials.gov registry record · Phase 1
Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00506779: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00506779 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00506779, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Objectives: * To determine the maximum tolerated dose (MTD) of imatinib mesylate in combination with fixed dose paclitaxel in patients with stage IIIC, IV or recurrent uterine papillary serous carcinoma. * To determine the nature and degree of toxicity of imatinib mesylate and paclitaxel in this cohort of patients. * To determine the efficacy of imatinib mesylate and paclitaxel in patients with stage IIIC, IV or recurrent uterine papillary serous carcinoma whose tumor expresses either c-Kit, PDGFR or abl.
Primary Outcome
Maximum Tolerated Dose (MTD) of Oral Imatinib Mesylate in Combination with Fixed Dose Paclitaxel where MTD of Imatinib Mesylate (mg/m\^2 daily) to be determined with conventional 3+3 design, MTD is highest dose level in which 6 participants treated with at most 2 experiencing dose limiting toxicity (DLT). Study utilizes Common Terminology for Adverse Events Criteria (CTCAE) version 3.0 for adverse event reporting. Following cohorts of 3 at lower dose levels until 1 of 3 patients experiences DLT
Interventions
- DRUG Paclitaxel
- DRUG Imatinib Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2003-12-29 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
Why NCT00506779 stopped before completion
NCT00506779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT00506779 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00506779 about?
NCT00506779 is a clinical study titled "Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma". Objectives: * To determine the maximum tolerated dose (MTD) of imatinib mesylate in combination with fixed dose paclitaxel in patients with stage IIIC, IV or recurrent uterine papillary serous carcinoma. * To determine the nature and degree of toxicity of imatinib mesylate and paclitaxel in this co...
What is the current status of trial NCT00506779?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2003-12-29. Estimated completion is 2015-04.
What interventions are being tested in trial NCT00506779?
The interventions under investigation include: Paclitaxel (DRUG), Imatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT00506779?
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 NCT00506779's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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