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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00613132
The ClinicalTrials.gov registry entry for NCT00613132 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (28% lower). The listed sponsor is Annick Desjardins, which has 9 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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