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NCT01738646 · ClinicalTrials.gov registry record · Phase 2
Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT01738646: Completed Phase 2 study, sponsored by Duke University.
NCT01738646 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01738646, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
It has been shown that bevacizumab has significant anti-tumor activity in patients with recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics. Patients will be treated with a combination of bevacizumab and vorinostat.
Primary Outcome
The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deter
Interventions
- DRUG Bevacizumab
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT01738646 record still lists
NCT01738646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT01738646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01738646 about?
NCT01738646 is a clinical study titled "Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients". It has been shown that bevacizumab has significant anti-tumor activity in patients with recurrent glioblastoma multiforme. Vorinostat has modest anti-tumor activity against malignant glioma and can enhance the action of both chemotherapy and anti-angiogenics. Patients will be treated with a combinat...
What is the current status of trial NCT01738646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2013-01. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01738646?
The interventions under investigation include: Bevacizumab (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT01738646?
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 NCT01738646's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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