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

NCT01697072 | Terminated Phase 3 DMC

• 2 other identifiers: 200706222011-004923-11
• Study Type: interventional
• Target: 609
• Locations: 26 countries
• Sites: 184

Brief 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

Gastric Cancer

Keywords

Gastric Cancer; First Line Treatment Gastroesophageal Junction (GEJ); Gastroesophageal Junction Cancer (GEJ); GEJ Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  To determine if the treatment of rilotumumab in combination with ECX significantly improves overall survival in subjects with unresectable locally advanced or metastatic MET positive gastric or GEJ cancer

  3 years

Secondary Outcomes (7)

• PFS

  3 years

• TTP

  3 years

• ORR

  3 years

• DCR

  3 years

• TTR

  3 years

Study Arms (2)

Rilotumumab

EXPERIMENTAL

Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)

Drug: Rilotumumab; Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine

Placebo

PLACEBO COMPARATOR

Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)

Other: Placebo; Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine

Interventions

Rilotumumab DRUG

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.

Also known as: AMG102

Rilotumumab

Placebo OTHER

Placebo

Also known as: sterile protein-free solution

Placebo

Epirubicin DRUG

Epirubicin is an anthracycline cytotoxic agent.

Also known as: Ellence, Pharmorubicin PFS, Pharmorubicin RDF

Placebo; Rilotumumab

Cisplatin DRUG

Cisplatin is a non-cell cycle specific chemotherapeutic agent.

Also known as: Platinol, Platinol-AQ

Placebo; Rilotumumab

Capecitabine DRUG

Capecitabine is an oral fluoropyrimidine.

Also known as: Xeloda

Placebo; Rilotumumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Amgen: lead

Study Sites (189)

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Tucson, Arizona, 85724, United States

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Aurora, Colorado, 80045, United States

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Pueblo, Colorado, 81008, United States

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Chicago, Illinois, 60637, United States

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Baltimore, Maryland, 21231, United States

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Woodbury, Minnesota, 55125, United States

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Henderson, Nevada, 89052, United States

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New York, New York, 10065, United States

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Rochester, New York, 14642, United States

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Greensboro, North Carolina, 27403, United States

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Winston-Salem, North Carolina, 27103, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Nashville, Tennessee, 37232, United States

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Bedford, Texas, 76022, United States

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Dallas, Texas, 75246, United States

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Seattle, Washington, 98109, United States

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Randwick, New South Wales, 2031, Australia

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St Leonards, New South Wales, 2065, Australia

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Tweed Heads, New South Wales, 2485, Australia

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Douglas, Queensland, 4814, Australia

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Elizabeth Vale, South Australia, 5112, Australia

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Kurralta Park, South Australia, 5037, Australia

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Heidelberg, Victoria, 3084, Australia

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Ringwood East, Victoria, 3135, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Linz, 4010, Austria

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Salzburg, 5020, Austria

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Vienna, 1090, Austria

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Brussels, 1180, Belgium

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Brussels, 1200, Belgium

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Charleroi, 6000, Belgium

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Edegem, 2650, Belgium

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Liège, 4000, Belgium

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Roeselare, 8800, Belgium

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Belo Horizonte, Minas Gerais, 30150-321, Brazil

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Pelotas, Rio Grande do Sul, 96015-280, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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São Paulo, São Paulo, 01209-000, Brazil

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São Paulo, São Paulo, 01246-000, Brazil

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São Paulo, São Paulo, 01509-900, Brazil

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Plovdiv, 4000, Bulgaria

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Shumen, 9700, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1527, Bulgaria

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Sofia, 1606, Bulgaria

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Sofia, 1756, Bulgaria

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Varna, 9010, Bulgaria

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Vancouver, British Columbia, V5Z 4E6, Canada

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London, Ontario, N6A 4L6, Canada

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Toronto, Ontario, M4C 3E7, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Laval, Quebec, H7M 3L9, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Hořovice, 268 31, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 775 20, Czechia

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Prague, 120 00, Czechia

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Ústí nad Labem, 401 13, Czechia

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Aalborg, 9000, Denmark

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Århus C, 8000, Denmark

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Copenhagen, 2100, Denmark

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Odense, 5000, Denmark

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Bayonne, 64109, France

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Bordeaux, 33075, France

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Clermont-Ferrand, 63003, France

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Dijon, 21079, France

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Le Mans, 72000, France

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Limoges, 87042, France

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Lyon, 69373, France

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Lyon, 69437, France

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Marseille, 13385, France

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Montpellier, 34298, France

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Nice, 06189, France

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Périgueux, 24004, France

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Saint-Priest-en-Jarez, 42270, France

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Strasbourg, 67000, France

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Berlin, 13125, Germany

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Bielefeld, 33611, Germany

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Dresden, 01307, Germany

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Essen, 45276, Germany

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Frankfurt am Main, 60488, Germany

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Leipzig, 04103, Germany

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Magdeburg, 39104, Germany

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Mainz, 55131, Germany

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München, 81377, Germany

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München, 81737, Germany

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Oldenburg, 26133, Germany

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Schweinfurt, 97422, Germany

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Athens, 18547, Greece

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Heraklion - Crete, 71110, Greece

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Larissa, 41110, Greece

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Nea Kifissia, Athens, 14564, Greece

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Pátrai, 26500, Greece

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Thessaloniki, 54645, Greece

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Thessaloniki, 56429, Greece

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Budapest, 1097, Hungary

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Budapest, 1106, Hungary

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Győr, 9023, Hungary

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Nyíregyháza, 4400, Hungary

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Szeged, 6725, Hungary

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Szolnok, 5000, Hungary

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Aviano PN, 33081, Italy

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Brescia, 25124, Italy

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Catania, 95122, Italy

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Florence, 50134, Italy

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Napoli, 80131, Italy

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Pisa, 56126, Italy

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Roma, 00168, Italy

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Distrito Federal, Mexico City, 04380, Mexico

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Mexico City, Mexico City, 14000, Mexico

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Cuernavaca, Morelos, 62290, Mexico

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Toluca, State of Mexico, 50080, Mexico

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Bialystok, 15-027, Poland

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Elblag, 82-300, Poland

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Gdansk, 80-219, Poland

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Konin, 62-500, Poland

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Lodz, 93-513, Poland

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Warsaw, 02-781, Poland

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Aveiro, 3814-501, Portugal

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Guimarães, 4835-044, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4200-072, Portugal

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Santa Maria da Feira, 4520-211, Portugal

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Vila Real, 5000-508, Portugal

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Alba Iulia, 510077, Romania

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Baia Mare, 430241, Romania

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Brasov, 500091, Romania

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Bucharest, 010719, Romania

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Bucharest, 011461, Romania

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Cluj-Napoca, 400058, Romania

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Lasi, 700106, Romania

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Timișoara, 300167, Romania

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Chelyabinsk, 454087, Russia

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Ivanovo, 153013, Russia

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Kazan', 420029, Russia

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Krasnodar, 350040, Russia

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Moscow, 115478, Russia

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Saint Petersburg, 197758, Russia

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Samara, 443031, Russia

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Vladimir, 600020, Russia

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Bardejov, 085 01, Slovakia

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Bratislava, 833 10, Slovakia

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Poprad, 058 01, Slovakia

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Trenčín, 911 71, Slovakia

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Groenkloof, Gauteng, 0181, South Africa

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Cape Town, 7925, South Africa

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Johannesburg, 2193, South Africa

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Kraaifontein, 7570, South Africa

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Pretoria, 0002, South Africa

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Barcelona, Catalonia, 08035, Spain

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L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Terrassa, Catalonia, 08221, Spain

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A Coruña, Galicia, 15006, Spain

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Madrid, Madrid, 28050, Spain

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Pamplona, Navarre, 31008, Spain

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Oviedo, Principality of Asturias, 33011, Spain

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Eskilstuna, 631 88, Sweden

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Stockholm, 171 76, Sweden

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Bellinzona, 6500, Switzerland

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Bern, 3010, Switzerland

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Chur, 7000, Switzerland

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Ankara, 06100, Turkey (Türkiye)

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Gaziantep, 27100, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Dnipropetrovsk, 49102, Ukraine

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Kharkiv, 61070, Ukraine

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Kherson, 73035, Ukraine

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Kyiv, 03115, Ukraine

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Lutsk, 43018, Ukraine

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Lviv, 79031, Ukraine

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Mariupol, 87500, Ukraine

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Sumy, 40022, Ukraine

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Uzhhorod, 88000, Ukraine

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Belfast, BT9 7AB, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Guildford, GU2 7XX, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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London, NW1 2PQ, United Kingdom

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London, SE1 9RT, United Kingdom

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London, SW3 6JJ, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Northwood, HA6 2RN, United Kingdom

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Salisbury, SP2 8BJ, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Related Publications (2)

• 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.

  PMID: 28958504 DERIVED

• 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.

  PMID: 25712685 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

rilotumumab; Epirubicin; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 2, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: August 1, 2015
• Last Updated: February 9, 2016

Record last verified: 2016-01

Locations

RO (10); SL (4); BR (6); DK (4); SE (2); AU (8); TU (4); BE (6); GB (12); DE (12); BU (7); IT (7); CH (3); CA (6); CZ (5); US (16); FR (14); GR (7); ME (4); PL (6); PT (6); RU (8); HU (6); ZA (5); ES (7); UA (9)