In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overPharmaceutical / Industry20070622
2011-004923-11, NCT01697072

Trial Description

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

Eligibility Criteria

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%

Trial Contact Information

Trial Lead Organizations/Sponsors

Amgen, Incorporated

MDStudy Director

Amgen Call CenterPh: 866-572-6436

Trial Sites

U.S.A.
Arizona
  Tucson
 Research Site
Colorado
  Aurora
 Research Site
  Pueblo
 Research Site
Illinois
  Chicago
 Research Site
Maryland
  Baltimore
 Research Site
Minnesota
  Woodbury
 Research Site
Nevada
  Henderson
 Research Site
New York
  New York
 Research Site
  Rochester
 Research Site
North Carolina
  Greensboro
 Research Site
  Winston Salem
 Research Site
Pennsylvania
  Pittsburgh
 Research Site
Texas
  Bedford
 Research Site
  Dallas
 Research Site
Washington
  Seattle
 Research Site
Australia
New South Wales
  Randwick
 Research Site
  St Leonards
 Research Site
  Tweed Heads
 Research Site
Queensland
  Douglas
 Research Site
South Australia
  Elizabeth Vale
 Research Site
  Kurralta Park
 Research Site
Victoria
  Heidelberg
 Research Site
  Ringwood East
 Research Site
Austria
  Graz
 Research Site
  Innsbruck
 Research Site
  Linz
 Research Site
  Salzburg
 Research Site
  Wien
 Research Site
Belgium
  Bruxelles
 Research Site
  Charleroi
 Research Site
  Edegem
 Research Site
  Liege
 Research Site
  Roeselare
 Research Site
Brazil
  Pelotas
 Research Site
  São Paulo
 Research Site
Sao Paulo
  Santo Andre
 Research Site
  Sao Paulo
 Research Site
Canada
British Columbia
  Vancouver
 Research Site
Ontario
  London
 Research Site
  Toronto
 Research Site
Quebec
  Greenfield Park
 Research Site
  Laval
 Research Site
  Montreal
 Research Site
Czech Republic
  Horovice
 Research Site
  Hradec Kralove
 Research Site
  Olomouc
 Research Site
  Praha 2
 Research Site
  Usti nad Labem
 Research Site
Denmark
  Aalborg
 Research Site
  Copenhagen
 Research Site
  Odense
 Research Site
France
  Bayonne
 Research Site
  Bordeaux
 Research Site
  Clermont Ferrand Cedex 1
 Research Site
  Dijon cedex
 Research Site
  Le Mans
 Research Site
  Lyon Cedex 08
 Research Site
  Marseille cedex 5
 Research Site
  Montpellier Cedex 5
 Research Site
  Nice cedex 2
 Research Site
  Périgueux cedex
 Research Site
  Saint Priest en Jarez
 Research Site
  Strasbourg
 Research Site
Germany
  Berlin
 Research Site
  Dresden
 Research Site
  Essen
 Research Site
  Frankfurt am Main
 Research Site
  Leipzig
 Research Site
  Magdeburg
 Research Site
  Mainz
 Research Site
  München
 Research Site
  Schweinfurt
 Research Site
Greece
  Athens
 Research Site
  Heraklion
 Research Site
  Larissa
 Research Site
  Nea Kifissia, Athens
 Research Site
  Patra
 Research Site
  Thessaloniki
 Research Site
Hungary
  Budapest
 Research Site
  Gyor
 Research Site
  Nyiregyhaza
 Research Site
  Szeged
 Research Site
  Szolnok
 Research Site
Italy
  Aviano PN
 Research Site
  Brescia
 Research Site
  Catania
 Research Site
  Firenze
 Research Site
  Napoli
 Research Site
  Pisa
 Research Site
  Roma
 Research Site
Mexico
  Cuernavaca
 Research Site
  Distrito Federal
 Research Site
  Mexico
 Research Site
  Toluca
 Research Site
Poland
  Bialystok
 Research Site
  Elblag
 Research Site
  Gdansk
 Research Site
  Konin
 Research Site
  Lodz
 Research Site
  Warszawa
 Research Site
Portugal
  Aveiro
 Research Site
  Guimaraes
 Research Site
  Lisboa
 Research Site
  Porto
 Research Site
  Santa Maria da Feira
 Research Site
  Vila Real
 Research Site
Republic of Bulgaria
  Plovdiv
 Research Site
  Shumen
 Research Site
  Sofia
 Research Site
  Varna
 Research Site
Republic of South Africa
  Cape Town
 Research Site
  Groenkloof
 Research Site
  Johannesburg
 Research Site
  Kraaifontein
 Research Site
  Pretoria
 Research Site
Romania
  Alba Iulia
 Research Site
  Baia Mare
 Research Site
  Brasov
 Research Site
  Bucharest
 Research Site
  Cluj Napoca
 Research Site
  Cluj-Napoca
 Research Site
  Lasi
 Research Site
Russia
  Chelyabinsk
 Research Site
  Ivanovo
 Research Site
  Kazan
 Research Site
  Krasnodar
 Research Site
  Moscow
 Research Site
  Saint-Petersburg
 Research Site
  Samara
 Research Site
  Vladimir
 Research Site
Slovakia
  Bardejov
 Research Site
  Bratislava
 Research Site
  Poprad
 Research Site
  Trencin
 Research Site
Spain
  A Coruña
 Research Site
  Barcelona
 Research Site
  L'Hospitalet de Llobregat
 Research Site
  Madrid
 Research Site
  Oviedo
 Research Site
  Pamplona
 Research Site
  Terrassa
 Research Site
Sweden
  Eskilstuna
 Research Site
  Stockholm
 Research Site
Switzerland
  Bellinzona
 Research Site
  Bern
 Research Site
  Chur
 Research Site
  Zurich
 Research Site
Turkey
  Ankara
 Research Site
  Gaziantep
 Research Site
  Istanbul
 Research Site
  Izmir
 Research Site
Ukraine
  Dnipropetrovsk
 Research Site
  Kharkiv
 Research Site
  Kherson
 Research Site
  Kyiv
 Research Site
  Lutsk
 Research Site
  Lviv
 Research Site
  Mariupol
 Research Site
  Sumy
 Research Site
  Uzhgorod
 Research Site
United Kingdom
  Belfast
 Research Site
  Edinburgh
 Research Site
  Guildford
 Research Site
  Leicester
 Research Site
  London
 Research Site
  Manchester
 Research Site
  Newcastle Upon Tyne
 Research Site
  Northwood
 Research Site
  Salisbury
 Research Site
  Sutton
 Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01697072
ClinicalTrials.gov processed this data on September 18, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top