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NCT01339039 · ClinicalTrials.gov registry record · Phase 1
Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma
A Phase 1 study, sponsored by Patrick Y. Wen, MD.
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01339039: Clinical Trial Phase 1 study, sponsored by Patrick Y. Wen, MD.
NCT01339039 is a Phase 1 study that was terminated before completion, run by Patrick Y. Wen, MD. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01339039, a Phase 1 study, was terminated before completion, sponsored by Patrick Y. Wen, MD.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in patients with recurrent glioblastoma and has been studied extensively in other types of solid tumors. Plerixafor, also known as Mozobil, is FDA approved for use in patients with non-Hodgkin's lymphoma and multiple myeloma and has been used in treatment for other cancers. Information from experiments in laboratories suggests that the combination of plerixafor and bevacizumab may help prevent the growth of gliomas. Part 1: The investigators are looking for the highest dose of plerixafor that can be given safely with bevacizumab (with a 21 days on/7 days off regimen of plerixafor). The investigators will also do blood tests to find out how the body uses and breaks down the drug combination. Part 2: The investigators are looking to see if plerixafor can get past the blood-brain barrier and into brain tumors. The investigators will also do blood tests to find out how the body uses and breaks down the drug combination. Part 3: The investigators are looking for for more information re: safety and tolerability of plerixafor in combination with bevacizumab (with a 28 days on/0 days off regimen of plerixafor). The investigators will also do blood tests to find out how the body uses and breaks down the drug combination.
Primary Outcome
To determine the maximum tolerated dose (the highest dose combination that causes DLT in no more than 1 of 6 patients) of plerixafor 3 weeks on, 1 week off in combination with bevacizumab (every two weeks) in this patient population.
Interventions
- DRUG Bevacizumab
- PROCEDURE Surgery
- DRUG Plerixafor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-12 |
| Est. Completion | 2017-04-08 |
| Phase | Phase 1 |
Why NCT01339039 stopped before completion
NCT01339039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01339039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01339039 about?
NCT01339039 is a clinical study titled "Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma". Plerixafor in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. Bevacizumab, also known as Avastin, is FDA approved for use in patients with recurrent glioblastoma and has been studied extensively in other types of solid tumors. Plerixafor, also k...
What is the current status of trial NCT01339039?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2011-12. Estimated completion is 2017-04-08.
What interventions are being tested in trial NCT01339039?
The interventions under investigation include: Bevacizumab (DRUG), Surgery (PROCEDURE), Plerixafor (DRUG).
Who is sponsoring clinical trial NCT01339039?
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 NCT01339039's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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