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

NCT01697072 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 609

Last updated 2016-02-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

Rilotumumab

Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells.

OTHER

Placebo

Placebo

DRUG

Epirubicin

Epirubicin is an anthracycline cytotoxic agent.

DRUG

Cisplatin

Cisplatin is a non-cell cycle specific chemotherapeutic agent.

DRUG

Capecitabine

Capecitabine is an oral fluoropyrimidine.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-11-30
Completion
2015-08-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01697072 on ClinicalTrials.gov