First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma (RILOMET-1)
January 18, 2016 updated by: Amgen
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
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
609
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Research Site
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St Leonards, New South Wales, Australia, 2065
- Research Site
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Tweed Heads, New South Wales, Australia, 2485
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Queensland
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Douglas, Queensland, Australia, 4814
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
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Kurralta Park, South Australia, Australia, 5037
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Victoria
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Heidelberg, Victoria, Australia, 3084
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Ringwood East, Victoria, Australia, 3135
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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
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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
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São Paulo, Brazil, 01246-000
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30150-321
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Rio Grande do Sul
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Pelotas, Rio Grande do Sul, Brazil, 96015-280
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São Paulo
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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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Plovdiv, Bulgaria, 4000
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Shumen, Bulgaria, 9700
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Sofia, Bulgaria, 1527
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1756
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Sofia, Bulgaria, 1606
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Varna, Bulgaria, 9010
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
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Ontario
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London, Ontario, Canada, N6A 4L6
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Toronto, Ontario, Canada, M4C 3E7
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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
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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
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Aalborg, Denmark, 9000
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Copenhagen, Denmark, 2100
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Odense, Denmark, 5000
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Århus C, Denmark, 8000
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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
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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
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Saint Priest en Jarez Cedex, France, 42270
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Strasbourg, France, 67000
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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
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Oldenburg, Germany, 26133
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Schweinfurt, Germany, 97422
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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, 56429
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Thessaloniki, Greece, 54645
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Budapest, Hungary, 1106
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Budapest, Hungary, 1097
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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
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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
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Distrito Federal, Mexico, 04380
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Toluca, Mexico, 50080
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Distrito Federal
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Mexico, Distrito Federal, Mexico, 14000
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Morelos
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Cuernavaca, Morelos, Mexico, 62290
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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
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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
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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, 400015
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Cluj-Napoca, Romania, 400058
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Lasi, Romania, 700106
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Timisoara, Romania, 300167
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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
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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
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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
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Gauteng
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Groenkloof, Gauteng, South Africa, 0181
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Madrid, Spain, 28050
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Asturias
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Oviedo, Asturias, Spain, 33011
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Cataluña
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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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Galicia
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A Coruña, Galicia, Spain, 15006
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Navarra
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Pamplona, Navarra, Spain, 31008
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Eskilstuna, Sweden, 631 88
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Stockholm, Sweden, 171 76
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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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Ankara, Turkey, 06100
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Gaziantep, Turkey, 27100
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Istanbul, Turkey, 34390
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Izmir, Turkey, 35100
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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
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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, SE1 9RT
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London, United Kingdom, NW1 2PQ
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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
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Arizona
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Tucson, Arizona, United States, 85724
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Colorado
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Aurora, Colorado, United States, 80045
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Pueblo, Colorado, United States, 81008
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Illinois
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Chicago, Illinois, United States, 60637
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Maryland
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Baltimore, Maryland, United States, 21231
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Minnesota
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Woodbury, Minnesota, United States, 55125
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Nevada
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Henderson, Nevada, United States, 89052
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New York
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New York, New York, United States, 10065
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Rochester, New York, United States, 14642
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North Carolina
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Greensboro, North Carolina, United States, 27403
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Winston Salem, North Carolina, United States, 27103
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
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Tennessee
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Nashville, Tennessee, United States, 37232
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Texas
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Bedford, Texas, United States, 76022
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Dallas, Texas, United States, 75246
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Washington
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Seattle, Washington, United States, 98109
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Rilotumumab
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
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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 Names:
Epirubicin is an anthracycline cytotoxic agent.
Other Names:
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Other Names:
Capecitabine is an oral fluoropyrimidine.
Other Names:
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Placebo Comparator: Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
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Placebo
Other Names:
Epirubicin is an anthracycline cytotoxic agent.
Other Names:
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Other Names:
Capecitabine is an oral fluoropyrimidine.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Survival
Time Frame: 3 years
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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
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Safety
Time Frame: 3 years
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3 years
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PFS
Time Frame: 3 years
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Progression Free Survival (PFS)
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3 years
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TTP
Time Frame: 3 years
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Time to Progression (TTP)
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3 years
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ORR
Time Frame: 3 years
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Objective Response Rate (ORR)
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3 years
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DCR
Time Frame: 3 years
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Disease Control Rate (DCR)
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3 years
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TTR
Time Frame: 3 years
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Time to Response (TTR)
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3 years
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Immunogenicity
Time Frame: 3 years
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 26, 2012
First Submitted That Met QC Criteria
September 28, 2012
First Posted (Estimate)
October 2, 2012
Study Record Updates
Last Update Posted (Estimate)
February 9, 2016
Last Update Submitted That Met QC Criteria
January 18, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Adenocarcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Cisplatin
- Capecitabine
- Epirubicin
- Rilotumumab
Other Study ID Numbers
- 20070622
- 2011-004923-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.