First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma
NCT ID: NCT01697072
Last Updated: 2016-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
609 participants
INTERVENTIONAL
2012-10-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rilotumumab
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
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.
Epirubicin
Epirubicin is an anthracycline cytotoxic agent.
Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Capecitabine
Capecitabine is an oral fluoropyrimidine.
Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Placebo
Placebo
Epirubicin
Epirubicin is an anthracycline cytotoxic agent.
Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Capecitabine
Capecitabine is an oral fluoropyrimidine.
Interventions
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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.
Placebo
Placebo
Epirubicin
Epirubicin is an anthracycline cytotoxic agent.
Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Capecitabine
Capecitabine is an oral fluoropyrimidine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor MET-positive by immunohistochemistry (IHC)
* Evaluable (measurable or non-measurable) disease by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Exclusion Criteria
* 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%
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Tucson, Arizona, United States
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Aurora, Colorado, United States
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Pueblo, Colorado, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Woodbury, Minnesota, United States
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Henderson, Nevada, United States
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New York, New York, United States
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Rochester, New York, United States
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Greensboro, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Seattle, Washington, United States
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Randwick, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Tweed Heads, New South Wales, Australia
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Douglas, Queensland, Australia
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Elizabeth Vale, South Australia, Australia
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Kurralta Park, South Australia, Australia
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Heidelberg, Victoria, Australia
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Ringwood East, Victoria, Australia
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Belo Horizonte, Minas Gerais, Brazil
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Pelotas, Rio Grande do Sul, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Plovdiv, , Bulgaria
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Shumen, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Hořovice, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Aalborg, , Denmark
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Århus C, , Denmark
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Copenhagen, , Denmark
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Odense, , Denmark
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Bayonne, , France
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Bordeaux, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Le Mans, , France
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Limoges, , France
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Lyon, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Nice, , France
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Périgueux, , France
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Saint-Priest-en-Jarez, , France
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Strasbourg, , France
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Berlin, , Germany
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Bielefeld, , Germany
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Dresden, , Germany
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Essen, , Germany
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Frankfurt am Main, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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München, , Germany
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München, , Germany
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Oldenburg, , Germany
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Schweinfurt, , Germany
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Athens, , Greece
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Heraklion - Crete, , Greece
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Larissa, , Greece
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Nea Kifissia, Athens, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Nyíregyháza, , Hungary
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Szeged, , Hungary
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Szolnok, , Hungary
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Aviano PN, , Italy
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Brescia, , Italy
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Catania, , Italy
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Florence, , Italy
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Napoli, , Italy
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Pisa, , Italy
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Roma, , Italy
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Distrito Federal, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Cuernavaca, Morelos, Mexico
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Toluca, State of Mexico, Mexico
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Bialystok, , Poland
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Elblag, , Poland
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Gdansk, , Poland
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Konin, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Aveiro, , Portugal
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Guimarães, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Santa Maria da Feira, , Portugal
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Vila Real, , Portugal
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Alba Iulia, , Romania
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Baia Mare, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Lasi, , Romania
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Timișoara, , Romania
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Chelyabinsk, , Russia
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Ivanovo, , Russia
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Kazan', , Russia
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Krasnodar, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Vladimir, , Russia
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Poprad, , Slovakia
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Trenčín, , Slovakia
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Groenkloof, Gauteng, South Africa
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Kraaifontein, , South Africa
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Pretoria, , South Africa
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Terrassa, Catalonia, Spain
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A Coruña, Galicia, Spain
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Madrid, Madrid, Spain
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Pamplona, Navarre, Spain
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Oviedo, Principality of Asturias, Spain
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Eskilstuna, , Sweden
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Stockholm, , Sweden
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Bellinzona, , Switzerland
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Bern, , Switzerland
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Chur, , Switzerland
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Ankara, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Dnipropetrovsk, , Ukraine
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Kharkiv, , Ukraine
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Kherson, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Mariupol, , Ukraine
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Sumy, , Ukraine
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Uzhhorod, , Ukraine
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Belfast, , United Kingdom
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Edinburgh, , United Kingdom
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Guildford, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Northwood, , United Kingdom
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Salisbury, , United Kingdom
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Sutton, , United Kingdom
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2011-004923-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20070622
Identifier Type: -
Identifier Source: org_study_id
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