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GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

NCT00110721 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-03-06

No results posted yet for this study

Summary

This is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly used in cancer patients. In this Phase II study, patients with colon cancer which has spread, despite treatment with approved therapies, will receive GM-CT-01 plus 5-FU in monthly cycles for at least 2 cycles or until their disease progresses.

Conditions

Interventions

DRUG

GM-CT-01 plus 5-Fluorouracil

Single use vials, combined regimen of GM-CT-01 / 5-Fluorouracil (280 mg/m2 /500 mg/m2) given for 4 consecutive days in a 28 day cycle until disease progression.

Sponsors & Collaborators

  • Galectin Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2007-06-30
Completion
2008-02-29

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

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 NCT00110721 on ClinicalTrials.gov