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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: Completed Phase 1 study, sponsored by Duke University.
NCT00612989 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00612989 record still lists
NCT00612989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Temodar and O6-Benzylguanine is the first listed.
NCT00612989 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00612989's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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