Phase 2Terminated
GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer
A Phase II, Multi-Center, Open-Label Trial to Evaluate the Efficacy and Safety of Intravenous GM-CT-01 in Combination With 5-Fluorouracil When Administered in Monthly Cycles as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer
- Sponsor
- Galectin Therapeutics Inc. (Industry)
- Enrollment
- 20 enrolled
- Conditions
- Colorectal Cancer
- Interventions
- GM-CT-01 plus 5-Fluorouracil
- Ages
- adults, older adults
- Registry
- NCT00110721
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- frequency of objective complete or partial tumor response
- frequency of stable disease
History
Last registry update
Study completion
Primary completion
Started
Registered