First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma

Summary

This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin \& capecitabine (ECX) with rilotumumab or placebo for untreated advanced MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma

Timeline

Start

2012-10

Primary completion

2014-11

Completion

2015-08

Outcome

Missed primary endpoint

Stopped: “All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.”

paper stratified hazard ratio 1·34, 95% CI 1·10-1·63; p=0·003). PMID 28958504 ↗

paper Ligand-blocking inhibition of the MET pathway with rilotumumab is not effective in improving clinical outcomes PMID 28958504 ↗

Publications

• Catenacci DVT, Tebbutt NC, Davidenko I, Murad AM, Al-Batran SE, Ilson DH, Tjulandin S, Gotovkin E, Karaszewska B, Bondarenko I, Tejani MA, Udrea AA, Tehfe M, De Vita F, Turkington C, Tang R, Ang A, Zhang Y, Hoang T, Sidhu R, Cunningham D. Rilotumumab plus epirubicin, cisplatin, and capecitabine as first-line therapy in advanced MET-positive gastric or gastro-oesophageal junction cancer (RILOMET-1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1467-1482. doi: 10.1016/S1470-2045(17)30566-1. Epub 2017 Sep 25.
• Doshi S, Gisleskog PO, Zhang Y, Zhu M, Oliner KS, Loh E, Perez Ruixo JJ. Rilotumumab exposure-response relationship in patients with advanced or metastatic gastric cancer. Clin Cancer Res. 2015 Jun 1;21(11):2453-61. doi: 10.1158/1078-0432.CCR-14-1661. Epub 2015 Feb 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rilotumumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Capecitabine	Small molecule	625 mg/m2	Oral
Background	Cisplatin	Other / unclassified	60 mg/m2	Intravenous
Background	Epirubicin	Small molecule	50 mg/m2	Intravenous

Indications