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NCT00290771 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)
A Phase 2 study, sponsored by Novartis.
- Terminated
- Registry status
- Phase 2
- Development phase
- 231
- Enrollment target
NCT00290771: Clinical Trial Phase 2 study, sponsored by Novartis.
NCT00290771 is a Phase 2 study that was terminated before completion, run by Novartis. The registered enrollment target is 231 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00290771, a Phase 2 study, was terminated before completion, sponsored by Novartis.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 231 participants
- Enrollment target
Study Summary
This was an investigational study to assess the objective overall response (OOR) rate (complete response \[CR\] + partial response \[PR\]) of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme (brain tumors). This study also evaluated the duration of tumor response (as per MacDonald criteria), clinical benefit, progression-free survival rate at 6 and 12 months, and the survival rate at 12 and 24 months.
Primary Outcome
Patients with an OOR were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed with magnetic resonance imaging. A patient had a CR if the target tumors disappeared. A patient had a PR if there was a ≥ 50% reduction in the sum of the products of the largest perpendicular diameters of the target tumors compared to the baseline value. A best response of CR required at least 2 determinations of CR at least 4 weeks apart. A best response of PR requir
Interventions
- DRUG Imatinib tablets
- DRUG Hydroxyurea capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
Why NCT00290771 stopped before completion
NCT00290771 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher).
The record links to 0 conditions, and to 2 interventions - of which Imatinib tablets is the first listed.
NCT00290771 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00290771 about?
NCT00290771 is a clinical study titled "Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)". This was an investigational study to assess the objective overall response (OOR) rate (complete response \[CR\] + partial response \[PR\]) of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme (brain tumors). This study also ev...
What is the current status of trial NCT00290771?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 231 participants. The study started on 2006-02. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00290771?
The interventions under investigation include: Imatinib tablets (DRUG), Hydroxyurea capsules (DRUG).
Who is sponsoring clinical trial NCT00290771?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00290771's enrollment target sits among peer trials
231 257th of 2000 higher than 1,744 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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