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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: Completed Phase 1 study, sponsored by Annick Desjardins.
NCT00613054 is a Phase 1 study that has completed, run by Annick Desjardins. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00613054 record still lists
NCT00613054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Zactima, Gleevec, Hydroxyurea is the first listed.
NCT00613054 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00613054's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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