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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 is a Phase 1 study that has completed, run by Katy Peters. The registered enrollment target is 48 participants.
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.
Interventions
- DRUG Vorinostst/Bevacizumab/Temozolomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2009-10 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00939991
The ClinicalTrials.gov registry entry for NCT00939991 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Katy Peters, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vorinostst/Bevacizumab/Temozolomide is the first listed.
NCT00939991 reports 0 study locations.
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.
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