Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors

Phase 1

Terminated

• Conditions: Solid Tumors

• Registration Number: NCT00044785
• Lead Sponsor: Wellstat Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2002-09-04
• Study First Submitted QC: 2002-09-05
• Study First Posted: 2002-09-06
• Study Completion: 2004-03
• Status Verified: 2005-05
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and Maximum Tolerated Dose

Trial Locations

Locations (1)

University of Maryland, Greenebaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States