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NCT00085540 · ClinicalTrials.gov registry record · Phase 1
FR901228 in Treating Patients With Recurrent High-Grade Gliomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00085540: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00085540 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00085540, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of FR901228 and to see how well it works in treating patients with recurrent high-grade gliomas. FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Primary Outcome
dose limiting toxicity defined as: ANC \</=1000 or Platelets \<100K; SGOT \>/= 3X ULN and T. Bili \>/= 1.5 ULN grade 3 Nausea, vomiting, fatigue and asymptomatic hypocalcemia (treatment may continue after discuss with PI)
Interventions
- DRUG depsipeptide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-01 |
| Est. Completion | 2009-03 |
| Phase | Phase 1 |
What the finished NCT00085540 record still lists
NCT00085540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which depsipeptide is the first listed.
NCT00085540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00085540 about?
NCT00085540 is a clinical study titled "FR901228 in Treating Patients With Recurrent High-Grade Gliomas". This phase I/II trial is studying the side effects and best dose of FR901228 and to see how well it works in treating patients with recurrent high-grade gliomas. FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth
What is the current status of trial NCT00085540?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2005-01. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00085540?
The interventions under investigation include: depsipeptide (DRUG).
Who is sponsoring clinical trial NCT00085540?
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 NCT00085540's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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