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NCT00869401 · ClinicalTrials.gov registry record · Phase 1
Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 217
- Enrollment target
NCT00869401: Completed Phase 1 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00869401 is a Phase 1 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 217 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00869401, a Phase 1 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 217 participants
- Enrollment target
Study Summary
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. This randomized phase I/II trial is studying the best dose of dasatinib and to see how well it works compared with a placebo when given together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.
Primary Outcome
Overall survival (OS) is the primary endpoint and is defined as the time from study registration to time of death due to any cause. All patients who meet the eligibility criteria, have signed a consent form, and have received at least one dose of the regimens will be considered evaluable. Patients who are lost to follow-up will be censored at the date of their last follow-up. Patients still alive at the time of analysis will be censored. Only Phase II was evaluated for survival
Interventions
- OTHER placebo
- DRUG dasatinib
- DRUG temozolomide
- RADIATION radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2009-06 |
| Est. Completion | 2019-11-15 |
| Phase | Phase 1 |
What the finished NCT00869401 record still lists
NCT00869401 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT00869401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00869401 about?
NCT00869401 is a clinical study titled "Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme". Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different wa...
What is the current status of trial NCT00869401?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 217 participants. The study started on 2009-06. Estimated completion is 2019-11-15.
What interventions are being tested in trial NCT00869401?
The interventions under investigation include: placebo (OTHER), dasatinib (DRUG), temozolomide (DRUG), radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00869401?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00869401's enrollment target sits among peer trials
217 240th of 2000 higher than 1,758 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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