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NCT00613054 · ClinicalTrials.gov registry record · Phase 1
Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma
A Phase 1 study, sponsored by Annick Desjardins.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT00613054 is a Phase 1 study that has completed, run by Annick Desjardins. The registered enrollment target is 27 participants.
The verdict
NCT00613054, a Phase 1 study, has completed, sponsored by Annick Desjardins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Primary Objective To determine maximum tolerated dose \& dose limiting toxicity of Zactima when combined w standard dosing of imatinib mesylate \& hydroxyurea among pts w recurrent malignant glioma who are on \& not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety \& tolerability of Zactima + imatinib mesylate \& hydroxyurea To evaluate pharmacokinetics of Zactima among MG pts on \& not on enzyme inducing anti-epileptic drugs (EIAEDs) when combo w imatinib mesylate \& hydroxyurea To evaluate pharmacokinetics of imatinib mesylate among MG pts on \& not on EIAEDs when combo w Zactima \& hydroxyurea Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among recurrent malignant glioma (RMG) pts including radiographic response rate, 6-month progression free survival (PFS) rate \& median PFS
Interventions
- DRUG Zactima, Gleevec, Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-11 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00613054
The ClinicalTrials.gov registry entry for NCT00613054 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Annick Desjardins, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Zactima, Gleevec, Hydroxyurea is the first listed.
NCT00613054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00613054 about?
NCT00613054 is a clinical study titled "Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma". Primary Objective To determine maximum tolerated dose \& dose limiting toxicity of Zactima when combined w standard dosing of imatinib mesylate \& hydroxyurea among pts w recurrent malignant glioma who are on \& not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety \& tol...
What is the current status of trial NCT00613054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2007-11. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00613054?
The interventions under investigation include: Zactima, Gleevec, Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT00613054?
This trial is sponsored by Annick Desjardins, which has 9 total clinical trials registered on ClinicalTrials.gov.
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