drugset / Trial / NCT01286818

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

NCT01286818

Phase 1 Completed 6 enrolled Eli Lilly and Company
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2011-02
Primary completion
2012-02
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramucirumab Monoclonal antibody 8 mg/kg Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Levoleucovorin Unknown 200 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications