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NCT01266031 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
NCT01266031: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01266031 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01266031, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
Study Summary
The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied. The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.
Primary Outcome
PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year. Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registrat
Interventions
- DRUG vorinostat
- DRUG bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2011-07-12 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 1 |
What the finished NCT01266031 record still lists
NCT01266031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 2 interventions - of which vorinostat is the first listed.
NCT01266031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01266031 about?
NCT01266031 is a clinical study titled "Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma". The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied. The goal of this Phase II part of this ...
What is the current status of trial NCT01266031?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2011-07-12. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT01266031?
The interventions under investigation include: vorinostat (DRUG), bevacizumab (DRUG).
Who is sponsoring clinical trial NCT01266031?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01266031's enrollment target sits among peer trials
96 600th of 2000 higher than 1,391 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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