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NCT00369590 · ClinicalTrials.gov registry record · Phase 2
VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT00369590: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00369590 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00369590, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
This phase II trial is studying how well VEGF Trap works in treating patients with recurrent malignant or anaplastic gliomas that did not respond to temozolomide. VEGF Trap may stop the growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.
Primary Outcome
This design yields 85% power to detect a true 30% 6-month PFS rate, while maintaining .91 probability of rejecting for a true 15% 6-month PFS rate. pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression. Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- BIOLOGICAL ziv-aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2006-08 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT00369590 record still lists
NCT00369590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT00369590 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00369590 about?
NCT00369590 is a clinical study titled "VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide". This phase II trial is studying how well VEGF Trap works in treating patients with recurrent malignant or anaplastic gliomas that did not respond to temozolomide. VEGF Trap may stop the growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.
What is the current status of trial NCT00369590?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2006-08. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00369590?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), ziv-aflibercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT00369590?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00369590's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 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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