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NCT01186406 · ClinicalTrials.gov registry record · Phase 2
Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT01186406 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 41 participants.
The verdict
NCT01186406, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then the combination of Avastin and Temodar, after radiation is complete, on malignant brain tumors. About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation. Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed dose of Avastin intravenously (through the vein) every 14 days. They will also be given a higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.
Interventions
- RADIATION Radiation Therapy
- DRUG Avastin
- DRUG Temodar
- DRUG Gliadel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-06-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01186406
The ClinicalTrials.gov registry entry for NCT01186406 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Radiation Therapy is the first listed.
NCT01186406 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01186406 about?
NCT01186406 is a clinical study titled "Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)". The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then the combination of Avastin and Temodar, after radiation is complete, on malignant brain tumors. About six weeks a...
What is the current status of trial NCT01186406?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2011-04. Estimated completion is 2014-06-16.
What interventions are being tested in trial NCT01186406?
The interventions under investigation include: Radiation Therapy (RADIATION), Avastin (DRUG), Temodar (DRUG), Gliadel (DRUG).
Who is sponsoring clinical trial NCT01186406?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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