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NCT00611325 · ClinicalTrials.gov registry record · Phase 2
Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma
A Phase 2 study of Glioblastoma and Gliosarcoma, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT00611325: Completed Phase 2 study of Glioblastoma and Gliosarcoma, sponsored by Duke University.
NCT00611325 is a Phase 2 study of Glioblastoma and Gliosarcoma that has completed, run by Duke University. The registered enrollment target is 56 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00611325, a Phase 2 study of Glioblastoma and Gliosarcoma, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective To estimate 6-month progression free survival probability of patients with recurrent glioblastoma multiforme treated with bortezomib plus Avastin. This efficacy assessment will be made separately among patients on enzyme-inducing anti-epileptic drugs and non enzyme-inducing anti-epileptic drugs. Secondary Objectives To evaluate safety \& tolerability of bortezomib plus Avastin among patients with recurrent malignant glioma. To evaluate radiographic response, progression free survival \& overall survival of patients with recurrent malignant glioma treated with bortezomib plus Avastin
Primary Outcome
Percentage of participants surviving six months from the initiation of treatment without progression of disease. PFS was defined as the time from the initiation of treatment to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.
Conditions Studied
Interventions
- DRUG Bortezomib
- DRUG Avastin
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2008-05 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT00611325 record still lists
NCT00611325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (49% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Bortezomib is the first listed.
NCT00611325 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00611325 about?
NCT00611325 is a clinical study titled "Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma". Primary Objective To estimate 6-month progression free survival probability of patients with recurrent glioblastoma multiforme treated with bortezomib plus Avastin. This efficacy assessment will be made separately among patients on enzyme-inducing anti-epileptic drugs and non enzyme-inducing anti-ep...
What is the current status of trial NCT00611325?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2008-05. Estimated completion is 2013-10.
What conditions does trial NCT00611325 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma.
What interventions are being tested in trial NCT00611325?
The interventions under investigation include: Bortezomib (DRUG), Avastin (DRUG).
Who is sponsoring clinical trial NCT00611325?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00611325 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00611325's enrollment target sits among peer trials
56 83rd of 199 higher than 116 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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.
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