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NCT00437957 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Temozolomide, Valproic Acid and Radiation Therapy in Patients With Brain Metastases
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00437957: Clinical Trial Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00437957 is a Phase 1 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00437957, a Phase 1 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This type of study is called a "Phase I study". Its purpose is to determine the side effects of the two medicines listed in this study when given together with whole brain radiation, and the highest dose of valproic acid that can be given together with temozolomide and whole brain radiation. We will also study the drug combination's effectiveness in treating cancer. While both of these drugs and whole brain radiation have been used in people for many years, they have never been combined for the purpose of treating patients with cancer.
Interventions
- DRUG Temozolomide
- DRUG Valproic Acid
- PROCEDURE Whole Brain Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
Why NCT00437957 stopped before completion
NCT00437957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT00437957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00437957 about?
NCT00437957 is a clinical study titled "Phase I Study of Temozolomide, Valproic Acid and Radiation Therapy in Patients With Brain Metastases". This type of study is called a "Phase I study". Its purpose is to determine the side effects of the two medicines listed in this study when given together with whole brain radiation, and the highest dose of valproic acid that can be given together with temozolomide and whole brain radiation. We will...
What is the current status of trial NCT00437957?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2006-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00437957?
The interventions under investigation include: Temozolomide (DRUG), Valproic Acid (DRUG), Whole Brain Radiation Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00437957?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00437957's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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