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NCT00597493 · ClinicalTrials.gov registry record · Phase 2
Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM
A Phase 2 study of Recurrent Glioblastoma Multiforme, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT00597493 is a Phase 2 study of Recurrent Glioblastoma Multiforme that has completed, run by Duke University. The registered enrollment target is 32 participants, below the 98-participant average among 6 other Recurrent Glioblastoma Multiforme trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00597493, a Phase 2 study of Recurrent Glioblastoma Multiforme, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
PURPOSE AND OBJECTIVES: Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS. Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib plus temozolomide; To determine the pharmacokinetics of Sorafenib when combined with temozolomide in patients on and not on concurrent EIAC medications.
Conditions Studied
Interventions
- DRUG Sorafenib and Temozolomide
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00597493
The ClinicalTrials.gov registry entry for NCT00597493 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 6 other Recurrent Glioblastoma Multiforme trials with a reported enrollment target (67% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Recurrent Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which Sorafenib and Temozolomide is the first listed.
NCT00597493 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00597493 about?
NCT00597493 is a clinical study titled "Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM". PURPOSE AND OBJECTIVES: Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS. Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib p...
What is the current status of trial NCT00597493?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2007-09. Estimated completion is 2010-12.
What conditions does trial NCT00597493 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma Multiforme.
What interventions are being tested in trial NCT00597493?
The interventions under investigation include: Sorafenib and Temozolomide (DRUG).
Who is sponsoring clinical trial NCT00597493?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00597493 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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