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NCT00321594 · ClinicalTrials.gov registry record · Phase 1
Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT00321594: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00321594 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00321594, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of belinostat and to see how well it works in treating patients with liver cancer that cannot be removed by surgery. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Primary Outcome
DLT is defined as any grade 4 hematological toxicity and any grade 3 or 4 non hematological toxicity during cycle 1, excluding alopecia. Specifically, grade 3 nausea, vomiting, or diarrhea that does not respond to therapy is considered dose-limiting. Also, delays in treatment greater than 2 weeks are also dose-limiting. MTD is defined as the dose below which \>= 2 of 3 or \>= 2 of 6 patients experience DLT. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse
Interventions
- DRUG belinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2006-05 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT00321594 record still lists
NCT00321594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which belinostat is the first listed.
NCT00321594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00321594 about?
NCT00321594 is a clinical study titled "Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery". This phase I/II trial is studying the side effects and best dose of belinostat and to see how well it works in treating patients with liver cancer that cannot be removed by surgery. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
What is the current status of trial NCT00321594?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2006-05. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00321594?
The interventions under investigation include: belinostat (DRUG).
Who is sponsoring clinical trial NCT00321594?
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 NCT00321594's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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