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Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors

NCT00054977 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-03-12

No results posted yet for this 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.

Conditions

Interventions

DRUG

GM-CT-01

IV infusion over 30 minutes of 6 Dosages escalated from 30 to 280 mg/m2, given for 4 consecutive days in a 28 days cycle.

DRUG

5-fluorouracil

IV infusion over 30 minutes at Dosage of 500 mg/m2, given in-combination with GM-CT-01, for 4 consecutive days in a 28 days cycle.

Sponsors & Collaborators

  • Galectin Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Marilyn C Pike, M.D., Ph.D. · Consultant to Pro-Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2005-04-30
Completion
2006-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00054977 on ClinicalTrials.gov