Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110721
Status:
TERMINATED
Last Update Posted:
2012-03-06
First Post:
2005-05-12
Brief Title:
GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer
Sponsor:
Galectin Therapeutics Inc
Organization:
Galectin Therapeutics Inc
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study protocol amended to a new treatment regimen study DAVFU-006
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
A Phase I study of 40 patients showed that GM-CT-01 in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard approved treatments The main reason for doing this Phase II study in advanced colorectal cancer patients is to verify the safety observations in the early Phase I study and further evaluate the efficacy of these drugs combination to stabilize tumors preventing further growth and potentially shrink tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None