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NCT00044785 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors
A Phase 1 study, sponsored by Wellstat Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00044785: Clinical Trial Phase 1 study, sponsored by Wellstat Therapeutics.
NCT00044785 is a Phase 1 study that was terminated before completion, run by Wellstat Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00044785, a Phase 1 study, was terminated before completion, sponsored by Wellstat Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness.
Interventions
- DRUG fluorouracil
- DRUG leucovorin
- DRUG triacetyluridine
- DRUG camptosar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2002-08 |
| Est. Completion | 2004-03 |
| Phase | Phase 1 |
Why NCT00044785 stopped before completion
NCT00044785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which fluorouracil is the first listed.
NCT00044785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00044785 about?
NCT00044785 is a clinical study titled "Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors". CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen wil...
What is the current status of trial NCT00044785?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2002-08. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00044785?
The interventions under investigation include: fluorouracil (DRUG), leucovorin (DRUG), triacetyluridine (DRUG), camptosar (DRUG).
Who is sponsoring clinical trial NCT00044785?
This trial is sponsored by Wellstat Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00044785's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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