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NCT00662506 · ClinicalTrials.gov registry record · Phase 1
Cediranib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT00662506: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00662506 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00662506, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of cediranib to see how well it works when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cediranib together with temozolomide and radiation therapy may kill more tumor cells.
Primary Outcome
The fraction of patients alive and free of disease progression after the MRI scan scheduled. This fraction will be compared, using a one sample, two-sided exact binomial test, to 50% progression-free survival (PFS). For safety assessment, the study will be powered to ensure at least 85% chance of observing a serious adverse event, if the probability of such an event on treatment were \>=5%.
Interventions
- RADIATION Fludeoxyglucose F-18
- PROCEDURE Diffusion Weighted Imaging
- PROCEDURE Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- DRUG Cediranib Maleate
- PROCEDURE Diffusion Tensor Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-04 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT00662506 record still lists
NCT00662506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludeoxyglucose F-18 is the first listed.
NCT00662506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00662506 about?
NCT00662506 is a clinical study titled "Cediranib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma". This phase I/II trial is studying the side effects and best dose of cediranib to see how well it works when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma. Cediranib may stop the growth of tumor cells by blocking some of the enzymes need...
What is the current status of trial NCT00662506?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2008-04. Estimated completion is 2014-04.
What interventions are being tested in trial NCT00662506?
The interventions under investigation include: Fludeoxyglucose F-18 (RADIATION), Diffusion Weighted Imaging (PROCEDURE), Dynamic Contrast-Enhanced Magnetic Resonance Imaging (PROCEDURE), Cediranib Maleate (DRUG), Diffusion Tensor Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT00662506?
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 NCT00662506's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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