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NCT00054977 · ClinicalTrials.gov registry record · Phase 1
Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors
A Phase 1 study, sponsored by Galectin Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00054977: Completed Phase 1 study, sponsored by Galectin Therapeutics.
NCT00054977 is a Phase 1 study that has completed, run by Galectin Therapeutics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00054977, a Phase 1 study, has completed, sponsored by Galectin Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a Phase I, multi-center study of GM-CT-01, which has been shown to increase the anti-tumor activity of 5-fluorouracil in mice. The primary reason for doing the study is to determine the safety of GM-CT-01 given alone and in combination with therapeutical dosage of 5-Fluorouracil, in patients who have advanced cancer that can be measured by CT scan.
Interventions
- DRUG 5-fluorouracil
- DRUG GM-CT-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2003-02 |
| Est. Completion | 2006-09 |
| Phase | Phase 1 |
What the finished NCT00054977 record still lists
NCT00054977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which 5-fluorouracil is the first listed.
NCT00054977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00054977 about?
NCT00054977 is a clinical study titled "Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors". This is a Phase I, multi-center study of GM-CT-01, which has been shown to increase the anti-tumor activity of 5-fluorouracil in mice. The primary reason for doing the study is to determine the safety of GM-CT-01 given alone and in combination with therapeutical dosage of 5-Fluorouracil, in patients...
What is the current status of trial NCT00054977?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2003-02. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00054977?
The interventions under investigation include: 5-fluorouracil (DRUG), GM-CT-01 (DRUG).
Who is sponsoring clinical trial NCT00054977?
This trial is sponsored by Galectin Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00054977's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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