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NCT00081900 · ClinicalTrials.gov registry record · Phase 1
A Safety and Efficacy Study of DENSPM in Patients With Liver Cancer Who Are Not Eligible for Surgical Care
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT00081900: Clinical Trial Phase 1 study, sponsored by Genzyme, a Sanofi Company.
NCT00081900 is a Phase 1 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00081900, a Phase 1 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM at approximately 5 centers in the United States. First, we will be trying to determine the highest dose that can be given safely and is well tolerated (this is called the maximally tolerated dose, or the MTD, for short). Once that is established, we will enroll additional patients to learn more about potential side effects and to see whether DENSPM can slow the growth of HCC tumors. We also want to learn about the safety of DENSPM. Many medications used to treat cancer cause side effects (discomforts or illness). In this study, we want to understand what side effects occur in patients with HCC who are treated with DENSPM.Study was terminated after initial assessment of insufficient data to support clinical benefit in this population.
Interventions
- DRUG DENSPM )
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2004-03 |
| Est. Completion | 2007-11 |
| Phase | Phase 1 |
Why NCT00081900 stopped before completion
NCT00081900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which DENSPM ) is the first listed.
NCT00081900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00081900 about?
NCT00081900 is a clinical study titled "A Safety and Efficacy Study of DENSPM in Patients With Liver Cancer Who Are Not Eligible for Surgical Care". Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM at approximately 5 centers in the United States. First, we will be trying to determine the highest dose that can be given safely and is well tolerated (this is called the maximally tolerated dose, or the MTD...
What is the current status of trial NCT00081900?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2004-03. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00081900?
The interventions under investigation include: DENSPM ) (DRUG).
Who is sponsoring clinical trial NCT00081900?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00081900's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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