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NCT00613132 · ClinicalTrials.gov registry record · Phase 1
Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG
A Phase 1 study of Glioblastoma and Gliosarcoma, sponsored by Annick Desjardins.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT00613132: Completed Phase 1 study of Glioblastoma and Gliosarcoma, sponsored by Annick Desjardins.
NCT00613132 is a Phase 1 study of Glioblastoma and Gliosarcoma that has completed, run by Annick Desjardins. The registered enrollment target is 78 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00613132, a Phase 1 study of Glioblastoma and Gliosarcoma, has completed, sponsored by Annick Desjardins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary objective To determine maximum tolerated dose \& dose limiting toxicity of imatinib mesylate \& RAD001 when combined w fixed doses of hydroxyurea among pts w recurrent GBM who are on \& not on enzyme-inducing anti-convulsants including pts not on anti-epileptic drugs Secondary objective To assess safety \& tolerability of imatinib mesylate in combo w RAD001 \& hydroxyurea in this population To characterize single-dose \& repeated-dose pharmacokinetic profiles of imatinib mesylate \& RAD001 combo therapy in this pt population. To assess antiangiogenic effects, pre- and post-treatment, of imatinib mesylate, RAD001 \& hydroxyurea combo therapy, using DCE-MRI to evaluate changes in extent of vascular permeability, perfusion \& relative tumor blood volume; to explore assessment of tumor cellularity \& tumor cell death by changes in DWI-MRI as quantitated by apparent diffusion coefficient maps.
Conditions Studied
Interventions
- DRUG Gleevec, RAD001, and Hydroxyurea
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2005-05 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT00613132 record still lists
NCT00613132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (28% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Gleevec, RAD001, and Hydroxyurea is the first listed.
NCT00613132 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00613132 about?
NCT00613132 is a clinical study titled "Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG". Primary objective To determine maximum tolerated dose \& dose limiting toxicity of imatinib mesylate \& RAD001 when combined w fixed doses of hydroxyurea among pts w recurrent GBM who are on \& not on enzyme-inducing anti-convulsants including pts not on anti-epileptic drugs Secondary objective To a...
What is the current status of trial NCT00613132?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2005-05. Estimated completion is 2013-01.
What conditions does trial NCT00613132 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma.
What interventions are being tested in trial NCT00613132?
The interventions under investigation include: Gleevec, RAD001, and Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT00613132?
This trial is sponsored by Annick Desjardins, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00613132 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00613132's enrollment target sits among peer trials
78 59th of 199 higher than 139 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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