A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer

Summary

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until disease progression, unacceptable toxicity, participant or physician decision to discontinue treatment.

Timeline

Start

2012-11

Primary completion

2015-12

Completion

2015-12

Outcome

Missed primary endpoint

paper OS hazard ratio [HR], 0.82; 95% CI, 0.59-1.15; P = .24 PMID 27918764 ↗

paper OS HR, 0.64; 95% CI, 0.40-1.03; P = .06 PMID 27918764 ↗

Publications

• Shah MA, Bang YJ, Lordick F, Alsina M, Chen M, Hack SP, Bruey JM, Smith D, McCaffery I, Shames DS, Phan S, Cunningham D. Effect of Fluorouracil, Leucovorin, and Oxaliplatin With or Without Onartuzumab in HER2-Negative, MET-Positive Gastroesophageal Adenocarcinoma: The METGastric Randomized Clinical Trial. JAMA Oncol. 2017 May 1;3(5):620-627. doi: 10.1001/jamaoncol.2016.5580.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Onartuzumab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Indications