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NCT00734526 · ClinicalTrials.gov registry record · Phase 1
Phase I Portion of Phase I/II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00734526: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00734526 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00734526, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of sorafenib that can be given in combination with temozolomide. The safety of this combination will also be studied.
Primary Outcome
MTD of sorafenib given during (concurrently with) external beam radiation therapy and daily temozolomide (75mg/m\^2), and with standard dose temozolomide (150-200mg/m\^2 5 days out of 28) after radiation therapy (adjuvant) in patients with newly diagnosed glioblastoma or gliosarcoma MTD is defined as the dose level below which there were 2 or more participants out of 6 with Dose-limiting toxicities (DLTs). by the conclusion of the first cycle of post-radiation therapy (14 weeks),
Interventions
- DRUG Temozolomide
- RADIATION Radiation
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-12-18 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
Why NCT00734526 stopped before completion
NCT00734526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT00734526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00734526 about?
NCT00734526 is a clinical study titled "Phase I Portion of Phase I/II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma". The goal of this clinical research study is to find the highest tolerable dose of sorafenib that can be given in combination with temozolomide. The safety of this combination will also be studied.
What is the current status of trial NCT00734526?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-12-18. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00734526?
The interventions under investigation include: Temozolomide (DRUG), Radiation (RADIATION), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00734526?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00734526's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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