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

Status:	Terminated
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - 99
Updated:	4/21/2016
Start Date:	October 2012
End Date:	August 2015

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Rilotumumab (AMG102) With Epirubicin, Cisplatin, and Capecitabine (ECX) as First-line Therapy in Advanced MET-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

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

Key Inclusion Criteria:

- Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ
adenocarcinoma •Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1)

- Tumor MET-positive by immunohistochemistry (IHC)

- Evaluable (measurable or non-measurable) disease by Response Evaluation Criteria In
Solid Tumors (RECIST) 1.1 criteria

Key exclusion criteria:

- Human Epidermal Growth Factor Receptor 2 (HER2) -overexpressing locally advanced or
metastatic gastric or GEJ adenocarcinoma •Previous systemic therapy for locally
advanced or metastatic gastric or GEJ adenocarcinoma

- Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant
chemotherapy or chemoradiotherapy to randomization

- Previous treatment with anthracyclines must not exceed total cumulative dose of
epirubicin of 400 mg/m2

- Squamous cell histology

- Left ventricular ejection fraction (LVEF) < 50%

We found this trial at

sites

Clinical Trial Facility in Bedford Texas

Bedford, Texas 76022

from

Bedford, TX