NCT01286818

A Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B)

A Phase 1b Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B) Drug Product in Japanese Subjects With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to investigate the safety and tolerability of the anti-vascular endothelial growth factor receptor-2 (anti-VEGFR-2) monoclonal antibody Ramucirumab (IMC-1121B) in combination with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) in Japanese participants with advanced colorectal carcinoma (CRC).

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Ramucirumab (IMC-1121B)	Ramucirumab (IMC-1121B): Intravenous (IV) infusions, 8 milligrams per kilogram (mg/kg) every 2 weeks
DRUG	Irinotecan	IV Infusion, 180 milligrams per square meter (mg/m²) every 2 weeks
DRUG	levofolinate	IV infusion, 200 mg/m² every 2 weeks
DRUG	5-Fluorouracil (5-FU)	400 mg/m² bolus followed by a 2400 mg/m² continuous infusion, every 2 weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2011-01-31
• Last updated: 2014-10-06
• Results posted: 2014-10-06

Locations

3 sites across 1 country: Japan