A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Colorectal Cancer
Interventions
DRUG

GM-CT-01

On Day 1 and 2 of each cycle, GM-CT-01 280 mg/m2 administered IV over 30 minutes with 5-FU (400 mg/m2), followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) with 5-FU (600 mg/m2 .)

DRUG

5-Fluorouracil, Leukovorin, bevacizumab

On Day 1 and 2 of each cycle, LV (200 mg/m2) will be administered IV over 2 hours, followed by 5-FU 400 mg/m2 in solution with GM-CT-01 280 mg/m2 administered over 30 minutes, followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) and 5-FU (600 mg/m2 ). on Day 3 Avastin® (5 mg/kg)will be given IV over 30 to 90 minutes per the package insert.

Trial Locations (4)

31096

Rambam Medical Center, Haifa

52621

Sheba MC, Tel Litwinsky

64239

Sourasky Medical Center, Tel Aviv

Unknown

Kaplan MC, Rehovot

Sponsors
All Listed Sponsors
lead

Galectin Therapeutics Inc.

INDUSTRY