A Study of Ramucirumab or Icrucumab in Colorectal Cancer

Phase 2 Completed 158 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

Timeline

Start: 2010-08
Primary completion: 2013-12
Completion: 2013-12

Publications

Moore M, Gill S, Asmis T, Berry S, Burkes R, Zbuk K, Alcindor T, Jeyakumar A, Chan T, Rao S, Spratlin J, Tang PA, Rothenstein J, Chan E, Bendell J, Kudrik F, Kauh J, Tang S, Gao L, Kambhampati SR, Nasroulah F, Yang L, Ramdas N, Binder P, Strevel E. Randomized phase II study of modified FOLFOX-6 in combination with ramucirumab or icrucumab as second-line therapy in patients with metastatic colorectal cancer after disease progression on first-line irinotecan-based therapy. Ann Oncol. 2016 Dec;27(12):2216-2224. doi: 10.1093/annonc/mdw412. Epub 2016 Oct 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Icrucumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Ramucirumab	Monoclonal antibody	8 mg/kg	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Levoleucovorin	Unknown	200 mg/m2	—
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

A Study of Ramucirumab or Icrucumab in Colorectal Cancer

Summary

Timeline

Publications

Drugs

Indications