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NCT00612989 · ClinicalTrials.gov registry record · Phase 1
Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00612989 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 42 participants.
The verdict
NCT00612989, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar® in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment cycle between days 7 \& 14 in pts w progressive/recurrent GBM To obtain preliminary response rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM
Interventions
- DRUG Temodar and O6-Benzylguanine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00612989
The ClinicalTrials.gov registry entry for NCT00612989 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Temodar and O6-Benzylguanine is the first listed.
NCT00612989 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00612989 about?
NCT00612989 is a clinical study titled "Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM". Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To...
What is the current status of trial NCT00612989?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2005-02. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00612989?
The interventions under investigation include: Temodar and O6-Benzylguanine (DRUG).
Who is sponsoring clinical trial NCT00612989?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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