FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer

Phase 2 Completed 194 enrolled Genentech, Inc. SCRI Development Innovations, LLC · collab

Parallel-groupDouble-blindTreatment

Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.

Timeline

Start: 2011-09-14
Primary completion: 2013-03-18
Completion: 2013-03-18

Outcome

Missed primary endpoint

paper At the time of the final analysis in February 2014, no significant improvement in PFS was seen with onartuzumab versus placebo in either the ITT or MET IHC-positive populations. PMID 28209746 ↗

Publications

Bendell JC, Hochster H, Hart LL, Firdaus I, Mace JR, McFarlane JJ, Kozloff M, Catenacci D, Hsu JJ, Hack SP, Shames DS, Phan SC, Koeppen H, Cohn AL. A Phase II Randomized Trial (GO27827) of First-Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer. Oncologist. 2017 Mar;22(3):264-271. doi: 10.1634/theoncologist.2016-0223. Epub 2017 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Onartuzumab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Background	Leucovorin	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous