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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 (RILOMET-1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01697072
First received: September 26, 2012
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Gastric Cancer
Drug: Rilotumumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • PFS [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Progression Free Survival (PFS)

  • TTP [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Time to Progression (TTP)

  • ORR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Objective Response Rate (ORR)

  • DCR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Disease Control Rate (DCR)

  • TTR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Time to Response (TTR)

  • Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Immunogenicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: October 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rilotumumab
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
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 Name: AMG102
Placebo Comparator: Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Other: Placebo
Placebo
Other Name: sterile protein-free solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697072

Contacts
Contact: Amgen Call Center 866-572-6436

  Hide Study Locations
Locations
United States, Arizona
Research Site Recruiting
Tucson, Arizona, United States, 85724
United States, Colorado
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Aurora, Colorado, United States, 80045
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Pueblo, Colorado, United States, 81008
United States, Illinois
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Chicago, Illinois, United States, 60637
United States, Maryland
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Baltimore, Maryland, United States, 21231
United States, Minnesota
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Woodbury, Minnesota, United States, 55125
United States, Nevada
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Henderson, Nevada, United States, 89052
United States, New York
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New York, New York, United States, 10065
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Rochester, New York, United States, 14642
United States, North Carolina
Research Site Completed
Greensboro, North Carolina, United States, 27403
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Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
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Nashville, Tennessee, United States, 37232
United States, Texas
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Bedford, Texas, United States, 76022
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Dallas, Texas, United States, 75246
United States, Washington
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Seattle, Washington, United States, 98109
Australia, New South Wales
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Randwick, New South Wales, Australia, 2031
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St Leonards, New South Wales, Australia, 2065
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Tweed Heads, New South Wales, Australia, 2485
Australia, Queensland
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Douglas, Queensland, Australia, 4814
Australia, South Australia
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Elizabeth Vale, South Australia, Australia, 5112
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Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
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Heidelberg, Victoria, Australia, 3084
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Ringwood East, Victoria, Australia, 3135
Austria
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Linz, Austria, 4010
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Salzburg, Austria, 5020
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Wien, Austria, 1090
Belgium
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Bruxelles, Belgium, 1200
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Bruxelles, Belgium, 1180
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Charleroi, Belgium, 6000
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Edegem, Belgium, 2650
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Liege, Belgium, 4000
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Roeselare, Belgium, 8800
Brazil
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Belo Horizonte, Minas Gerais, Brazil, 30150-321
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Pelotas, Rio Grande do Sul, Brazil, 96015-280
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Santo Andre, São Paulo, Brazil, 09060-650
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Sao Paulo, São Paulo, Brazil, 01509-900
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Sao Paulo, São Paulo, Brazil, 01209-000
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São Paulo, Brazil, 01246-000
Bulgaria
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Plovdiv, Bulgaria, 4000
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Shumen, Bulgaria, 9700
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Sofia, Bulgaria, 1527
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Sofia, Bulgaria, 1756
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1606
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Varna, Bulgaria, 9010
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
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London, Ontario, Canada, N6A 4L6
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Toronto, Ontario, Canada, M4C 3E7
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Laval, Quebec, Canada, H7M 3L9
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Montreal, Quebec, Canada, H2L 4M1
Czech Republic
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Horovice, Czech Republic, 268 31
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Hradec Kralove, Czech Republic, 500 05
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Olomouc, Czech Republic, 775 20
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Praha 2, Czech Republic, 120 00
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Usti nad Labem, Czech Republic, 401 13
Denmark
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Aalborg, Denmark, 9000
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Copenhagen, Denmark, 2100
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Odense, Denmark, 5000
France
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Bayonne, France, 64109
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Bordeaux, France, 33075
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Clermont Ferrand Cedex 1, France, 63003
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Dijon cedex, France, 21079
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Le Mans, France, 72000
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Limoges Cedex, France, 87042
Research Site Completed
Lyon Cedex 03, France, 69437
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Lyon Cedex 08, France, 69373
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Marseille cedex 5, France, 13385
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Montpellier Cedex 5, France, 34298
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Nice cedex 2, France, 06189
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Périgueux cedex, France, 24004
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Saint Priest en Jarez, France, 42270
Research Site Completed
Saint Priest en Jarez Cedex, France, 42270
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Strasbourg, France, 67000
Germany
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Berlin, Germany, 13125
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Bielefeld, Germany, 33611
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Dresden, Germany, 01307
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Essen, Germany, 45276
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Frankfurt am Main, Germany, 60488
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Leipzig, Germany, 04103
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Magdeburg, Germany, 39104
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Mainz, Germany, 55131
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München, Germany, 81377
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München, Germany, 81737
Research Site Completed
Oldenburg, Germany, 26133
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Schweinfurt, Germany, 97422
Greece
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Athens, Greece, 18547
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Heraklion - Crete, Greece, 71110
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Larissa, Greece, 41110
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Nea Kifissia, Athens, Greece, 14564
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Patra, Greece, 26500
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Thessaloniki, Greece, 54645
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Thessaloniki, Greece, 56429
Hungary
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Budapest, Hungary, 1097
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Budapest, Hungary, 1106
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Gyor, Hungary, 9023
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Nyiregyhaza, Hungary, 4400
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Szeged, Hungary, 6725
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Szolnok, Hungary, 5000
Italy
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Aviano PN, Italy, 33081
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Brescia, Italy, 25124
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Catania, Italy, 95122
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Firenze, Italy, 50134
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Napoli, Italy, 80131
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Pisa, Italy, 56126
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Roma, Italy, 00168
Mexico
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Mexico, Distrito Federal, Mexico, 14000
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Cuernavaca, Morelos, Mexico, 62290
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Distrito Federal, Mexico, 04380
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Toluca, Mexico, 50080
Poland
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Bialystok, Poland, 15-027
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Elblag, Poland, 82-300
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Gdansk, Poland, 80-219
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Konin, Poland, 62-500
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Lodz, Poland, 93-513
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Warszawa, Poland, 02-781
Portugal
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Aveiro, Portugal, 3814-501
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Guimaraes, Portugal, 4835-044
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Lisboa, Portugal, 1649-035
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Porto, Portugal, 4200-072
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Santa Maria da Feira, Portugal, 4520-211
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Vila Real, Portugal, 5000-508
Romania
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Alba Iulia, Romania, 510077
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Baia Mare, Romania, 430241
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Brasov, Romania, 500091
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Bucharest, Romania, 022328
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Bucharest, Romania, 011461
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Bucharest, Romania, 010719
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Cluj Napoca, Romania, 400015
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Cluj-Napoca, Romania, 400058
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Cluj-Napoca, Romania, 400015
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Lasi, Romania, 700106
Research Site Completed
Timisoara, Romania, 300167
Russian Federation
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Chelyabinsk, Russian Federation, 454087
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Ivanovo, Russian Federation, 153013
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Kazan, Russian Federation, 420029
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Krasnodar, Russian Federation, 350040
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Moscow, Russian Federation, 115478
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Saint-Petersburg, Russian Federation, 197758
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Samara, Russian Federation, 443031
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Vladimir, Russian Federation, 600020
Slovakia
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Bardejov, Slovakia, 085 01
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Bratislava, Slovakia, 833 10
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Poprad, Slovakia, 058 01
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Trencin, Slovakia, 911 71
South Africa
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Groenkloof, Gauteng, South Africa, 0181
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Cape Town, South Africa, 7925
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Johannesburg, South Africa, 2193
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Kraaifontein, South Africa, 7570
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Pretoria, South Africa, 0002
Spain
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Oviedo, Asturias, Spain, 33011
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Barcelona, Cataluña, Spain, 08035
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L'Hospitalet de Llobregat, Cataluña, Spain, 08907
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Terrassa, Cataluña, Spain, 08221
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A Coruña, Galicia, Spain, 15006
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Pamplona, Navarra, Spain, 31008
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Madrid, Spain, 28050
Sweden
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Eskilstuna, Sweden, 631 88
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Stockholm, Sweden, 171 76
Switzerland
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Bellinzona, Switzerland, 6500
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Bern, Switzerland, 3010
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Chur, Switzerland, 7000
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Zurich, Switzerland, 8032
Turkey
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Ankara, Turkey, 06100
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Gaziantep, Turkey, 27100
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Istanbul, Turkey, 34390
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Izmir, Turkey, 35100
Ukraine
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Dnipropetrovsk, Ukraine, 49102
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Kharkiv, Ukraine, 61070
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Kherson, Ukraine, 73035
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Kyiv, Ukraine, 03115
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Lutsk, Ukraine, 43018
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Lviv, Ukraine, 79031
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Mariupol, Ukraine, 87500
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Sumy, Ukraine, 40022
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Uzhgorod, Ukraine, 88000
United Kingdom
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Belfast, United Kingdom, BT9 7AB
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Edinburgh, United Kingdom, EH4 2XU
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Guildford, United Kingdom, GU2 7XX
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Leicester, United Kingdom, LE1 5WW
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London, United Kingdom, SW3 6JJ
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London, United Kingdom, NW1 2PQ
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London, United Kingdom, SE1 9RT
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Manchester, United Kingdom, M20 4BX
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
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Northwood, United Kingdom, HA6 2RN
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Salisbury, United Kingdom, SP2 8BJ
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Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01697072     History of Changes
Other Study ID Numbers: 20070622, 2011-004923-11
Study First Received: September 26, 2012
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Gastric Cancer
First Line Treatment Gastroesophageal Junction (GEJ)
Gastroesophageal Junction Cancer (GEJ)
GEJ Cancer

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases
Capecitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014