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NCT00042991 · ClinicalTrials.gov registry record · Phase 1
Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT00042991: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00042991 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00042991, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may make the tumor cells more sensitive to radiation therapy. This phase I/II trial is studying how well giving gefitinib together with radiation therapy works in treating children with newly diagnosed glioma.
Primary Outcome
The dose limiting toxicity (DLT) analysis population consists of stratum 1A phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD based on the tradional 3+3 design, where a dose is considered a safe dose only when 0 out of 3, or at most 1 out of 6 patients has DLTs. When two or more patients in a group of 2 to 6 pa
Interventions
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- RADIATION radiation therapy
- DRUG gefitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2002-07 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
What the finished NCT00042991 record still lists
NCT00042991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00042991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00042991 about?
NCT00042991 is a clinical study titled "Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas". Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may make the tumor cells more sensitive to radiation therapy. This phase I/II trial is studying how well giving gefitinib together with radiation therapy works in treating children with newly diagnosed glioma...
What is the current status of trial NCT00042991?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2002-07. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00042991?
The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), radiation therapy (RADIATION), gefitinib (DRUG).
Who is sponsoring clinical trial NCT00042991?
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 NCT00042991's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 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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