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NCT00939991 · ClinicalTrials.gov registry record · Phase 1
Suberoylanilide Hydroxamic Acid (SAHA), Bevacizumab, Daily Temozolomide for Recurrent Malignant Gliomas
A Phase 1 study, sponsored by Katy Peters.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00939991: Completed Phase 1 study, sponsored by Katy Peters.
NCT00939991 is a Phase 1 study that has completed, run by Katy Peters. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00939991, a Phase 1 study, has completed, sponsored by Katy Peters.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a Phase I/II open-label, single-arm study among recurrent malignant glioma patients. Patients will be treated with Vorinostat in combination with Bevacizumab (BV) (10 mg/kg) and Temozolomide (T) (50 mg/m2/day) BV is administered every 2 weeks. Temozolomide will be taken orally once every day. Vorinostat will be taken orally on days 1-7 and 15-21 of each 28-day cycle. In the phase I portion of this study, the dose of Vorinostat will be escalated in successive cohorts of patients to determine the maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs). In the phase II portion of this study, the dose of Vorinostat will be the MTD determined in the phase I portion. The primary endpoint of the phase II study is 6-month progression-free survival (PFS) for recurrent GBM (Glioblastoma) patients. This study will be conducted at The Preston Robert Tisch Brain Tumor Center at Duke.
Primary Outcome
The MTD is based upon dose-limiting toxicities (DLTs) experienced during Cycle 1 of treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with at least two patients experiencing DLT at the next higher dose level. Using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, DLTs are defined as: Grade 4 neutropenia lasting greater than 5 days; Grade 3 thrombocytopenia; the occurrence of non-hematologic Grade 3 or greater drug-related adverse events excluding
Interventions
- DRUG Vorinostst/Bevacizumab/Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2009-10 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT00939991 record still lists
NCT00939991 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which Vorinostst/Bevacizumab/Temozolomide is the first listed.
NCT00939991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00939991 about?
NCT00939991 is a clinical study titled "Suberoylanilide Hydroxamic Acid (SAHA), Bevacizumab, Daily Temozolomide for Recurrent Malignant Gliomas". This is a Phase I/II open-label, single-arm study among recurrent malignant glioma patients. Patients will be treated with Vorinostat in combination with Bevacizumab (BV) (10 mg/kg) and Temozolomide (T) (50 mg/m2/day) BV is administered every 2 weeks. Temozolomide will be taken orally once every day...
What is the current status of trial NCT00939991?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2009-10. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00939991?
The interventions under investigation include: Vorinostst/Bevacizumab/Temozolomide (DRUG).
Who is sponsoring clinical trial NCT00939991?
This trial is sponsored by Katy Peters, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00939991's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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