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NCT00612339 · ClinicalTrials.gov registry record · Phase 2
Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00612339: Completed Phase 2 study, sponsored by Duke University.
NCT00612339 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00612339, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
Primary objective- To determine efficacy of Avastin, 10 mg/kg every other week, in combination with standard 5-day temozolomide in terms of response rate. Secondary objective- To determine safety of Avastin \& Temozolomide in unresectable glioblastoma patients
Primary Outcome
The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defin
Interventions
- DRUG Avastin and Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2007-08 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT00612339 record still lists
NCT00612339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which Avastin and Temozolomide is the first listed.
NCT00612339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00612339 about?
NCT00612339 is a clinical study titled "Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas". Primary objective- To determine efficacy of Avastin, 10 mg/kg every other week, in combination with standard 5-day temozolomide in terms of response rate. Secondary objective- To determine safety of Avastin \& Temozolomide in unresectable glioblastoma patients
What is the current status of trial NCT00612339?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2007-08. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00612339?
The interventions under investigation include: Avastin and Temozolomide (DRUG).
Who is sponsoring clinical trial NCT00612339?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00612339's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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