NCT00851045

Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

A Randomized, Double-Blind, Phase II Trial of CT-322 (BMS-844203) Plus Irinotecan, 5-FU and Leucovorin (FOLFIRI) Versus Bevacizumab Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer

Conditions

• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
DRUG	Irinotecan	Solution, IV, 180 mg/m2, Q14 days, Until PD
DRUG	5-Fluorouracil (bolus)	Solution, IV, 400 mg/m2, Q14 days, Until PD
DRUG	5-Fluorouracil (infusional)	Solution, IV, 2400 mg/m2, Q14 days, Until PD
DRUG	Leucovorin calcium	Solution, IV, 400 mg/m2, Q14 days, Until PD
DRUG	CT-322	Solution, IV, 2 mg/kg, Q7 days, Until PD
DRUG	Bevacizumab	Solutions, IV, 5 mg/kg, Q14 days, Until PD
DRUG	Bevacizumab Placebo (saline solution)	Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2009-02-25
• Last updated: 2015-10-12

Locations

15 sites across 3 countries: United States, Argentina, Italy