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NCT00544817 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib for Glioblastoma Multiforme
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT00544817 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 47 participants.
The verdict
NCT00544817, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
The mechanism of action of sorafenib makes it an interesting drug to investigate in the treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic activity has already been demonstrated and the PDGF receptor target may also be pertinent in glioblastoma. The combination of temozolomide plus sorafenib has been investigated previously in the treatment of patients with advanced melanoma. The combination was generally well tolerated; in previously untreated patients, a standard dose of sorafenib (400mg PO bid) was administered with temozolomide 150mg/m2 PO daily for 5 days, repeated every 28 days (23). In this multicenter phase II study, patients with newly diagnosed glioblastoma will receive standard treatment, including initial debulking surgical resection (if feasible) followed by high-dose radiation therapy with concurrent temozolomide. After completion of radiation therapy, patients will continue treatment with temozolomide (150mg/m2 days 1-5) and sorafenib (400mg PO bid daily), repeated at 28-day intervals for 6 cycles.
Interventions
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00544817
The ClinicalTrials.gov registry entry for NCT00544817 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT00544817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00544817 about?
NCT00544817 is a clinical study titled "Radiation Therapy and Temozolomide Followed by Temozolomide Plus Sorafenib for Glioblastoma Multiforme". The mechanism of action of sorafenib makes it an interesting drug to investigate in the treatment of patients with glioblastoma multiforme. Efficacy of agents with anti-angiogenic activity has already been demonstrated and the PDGF receptor target may also be pertinent in glioblastoma. The combinati...
What is the current status of trial NCT00544817?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2007-04. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00544817?
The interventions under investigation include: Radiation Therapy (RADIATION), Temozolomide (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00544817?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
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