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NCT00045708 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT00045708: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00045708 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00045708, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase I/II trial is studying the side effects and best dose of ixabepilone and how well it works in treating patients with recurrent glioma.
Primary Outcome
Starting dose for both Group A and Group B was 5mg/m2/day. A continuing reassessment method (CRM) was employed independently for each group to estimate the maximum tolerated dose. Only toxicity observed during 1st cycle of treatment (21 days) was used for dose finding. Dose limiting toxicity (DLT) defined as: ANC\<500/ul, platelets\<25,000, febrile neutropenia or treatment-related grade 3 or 4 non-hematologic toxicity with the exception of nausea and vomiting.
Interventions
- OTHER pharmacological study
- DRUG ixabepilone
- DRUG Anticonvulsant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2002-10 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT00045708 record still lists
NCT00045708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which pharmacological study is the first listed.
NCT00045708 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00045708 about?
NCT00045708 is a clinical study titled "A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas". Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase I/II trial is studying the side effects and best dose of ixabepilone and how well it works in treating patients with recurrent glioma.
What is the current status of trial NCT00045708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2002-10. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00045708?
The interventions under investigation include: pharmacological study (OTHER), ixabepilone (DRUG), Anticonvulsant (DRUG).
Who is sponsoring clinical trial NCT00045708?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00045708's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 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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