NCT00862784

A Study of IMC-1121B (Ramucirumab) in Colorectal Cancer

An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B in Combination With 5-FU/FA and Oxaliplatin (Modified FOLFOX-6) as First-line Therapy in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy.

Detailed description

The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with the monoclonal antibody IMC-1121B (ramucirumab) in combination with the modified FOLFOX-6 \[folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6\] chemotherapy regimen as first-line therapy.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	IMC-1121B (ramucirumab)	8 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) infusions every 2 weeks
DRUG	Oxaliplatin	85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1
DRUG	Folinic acid	400 mg/m² intravenous infusion over 2 hours on Day 1
DRUG	5-FU	400 mg/m² intravenous bolus injection over 2-4 minutes, immediately following folinic acid infusion
DRUG	5-FU	2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU on Days 1 and 2

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-04-01
• Completion: 2011-08-01
• First posted: 2009-03-17
• Last updated: 2014-06-17
• Results posted: 2014-06-17

Locations

7 sites across 2 countries: Canada, Spain