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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 is a Phase 1 study that was terminated before completion, run by Wellstat Therapeutics. The registered enrollment target is 24 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00044785
The ClinicalTrials.gov registry entry for NCT00044785 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wellstat Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which fluorouracil is the first listed.
NCT00044785 reports 0 study locations.
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.
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