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NCT00859222 · ClinicalTrials.gov registry record · Phase 1
LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma
A Phase 1 study, sponsored by Patrick Y. Wen, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT00859222: Completed Phase 1 study, sponsored by Patrick Y. Wen, MD.
NCT00859222 is a Phase 1 study that has completed, run by Patrick Y. Wen, MD. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00859222, a Phase 1 study, has completed, sponsored by Patrick Y. Wen, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
Primary Outcome
The MTD LBH589 in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D). The MTD was not
Interventions
- DRUG bevacizumab
- DRUG LBH589
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2009-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT00859222 record still lists
NCT00859222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which bevacizumab is the first listed.
NCT00859222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00859222 about?
NCT00859222 is a clinical study titled "LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma". The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone...
What is the current status of trial NCT00859222?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2009-03. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00859222?
The interventions under investigation include: bevacizumab (DRUG), LBH589 (DRUG).
Who is sponsoring clinical trial NCT00859222?
This trial is sponsored by Patrick Y. Wen, MD, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00859222's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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