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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004923-11 | EudraCT Number |
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All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilotumumab | Experimental | Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX) |
|
| Placebo | Placebo Comparator | Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression Free Survival (PFS) | 3 years |
| TTP | Time to Progression (TTP) | 3 years |
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Key Inclusion Criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85724 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28958504 | Derived | 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. | |
| 25712685 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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|
| Placebo | Other | Placebo |
|
|
| Epirubicin | Drug | Epirubicin is an anthracycline cytotoxic agent. |
|
|
| Cisplatin | Drug | Cisplatin is a non-cell cycle specific chemotherapeutic agent. |
|
|
| Capecitabine | Drug | Capecitabine is an oral fluoropyrimidine. |
|
|
| ORR | Objective Response Rate (ORR) | 3 years |
| DCR | Disease Control Rate (DCR) | 3 years |
| TTR | Time to Response (TTR) | 3 years |
| Safety | 3 years |
| Immunogenicity | 3 years |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Research Site | Pueblo | Colorado | 81008 | United States |
| Research Site | Chicago | Illinois | 60637 | United States |
| Research Site | Baltimore | Maryland | 21231 | United States |
| Research Site | Woodbury | Minnesota | 55125 | United States |
| Research Site | Henderson | Nevada | 89052 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Rochester | New York | 14642 | United States |
| Research Site | Greensboro | North Carolina | 27403 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | Bedford | Texas | 76022 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Seattle | Washington | 98109 | United States |
| Research Site | Randwick | New South Wales | 2031 | Australia |
| Research Site | St Leonards | New South Wales | 2065 | Australia |
| Research Site | Tweed Heads | New South Wales | 2485 | Australia |
| Research Site | Douglas | Queensland | 4814 | Australia |
| Research Site | Elizabeth Vale | South Australia | 5112 | Australia |
| Research Site | Kurralta Park | South Australia | 5037 | Australia |
| Research Site | Heidelberg | Victoria | 3084 | Australia |
| Research Site | Ringwood East | Victoria | 3135 | Australia |
| Research Site | Graz | 8036 | Austria |
| Research Site | Innsbruck | 6020 | Austria |
| Research Site | Linz | 4010 | Austria |
| Research Site | Salzburg | 5020 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Brussels | 1180 | Belgium |
| Research Site | Brussels | 1200 | Belgium |
| Research Site | Charleroi | 6000 | Belgium |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Roeselare | 8800 | Belgium |
| Research Site | Belo Horizonte | Minas Gerais | 30150-321 | Brazil |
| Research Site | Pelotas | Rio Grande do Sul | 96015-280 | Brazil |
| Research Site | Santo André | São Paulo | 09060-650 | Brazil |
| Research Site | São Paulo | São Paulo | 01209-000 | Brazil |
| Research Site | São Paulo | São Paulo | 01246-000 | Brazil |
| Research Site | São Paulo | São Paulo | 01509-900 | Brazil |
| Research Site | Plovdiv | 4000 | Bulgaria |
| Research Site | Shumen | 9700 | Bulgaria |
| Research Site | Sofia | 1233 | Bulgaria |
| Research Site | Sofia | 1527 | Bulgaria |
| Research Site | Sofia | 1606 | Bulgaria |
| Research Site | Sofia | 1756 | Bulgaria |
| Research Site | Varna | 9010 | Bulgaria |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | London | Ontario | N6A 4L6 | Canada |
| Research Site | Toronto | Ontario | M4C 3E7 | Canada |
| Research Site | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Research Site | Laval | Quebec | H7M 3L9 | Canada |
| Research Site | Montreal | Quebec | H2L 4M1 | Canada |
| Research Site | Hořovice | 268 31 | Czechia |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | Olomouc | 775 20 | Czechia |
| Research Site | Prague | 120 00 | Czechia |
| Research Site | Ústí nad Labem | 401 13 | Czechia |
| Research Site | Aalborg | 9000 | Denmark |
| Research Site | Århus C | 8000 | Denmark |
| Research Site | Copenhagen | 2100 | Denmark |
| Research Site | Odense | 5000 | Denmark |
| Research Site | Bayonne | 64109 | France |
| Research Site | Bordeaux | 33075 | France |
| Research Site | Clermont-Ferrand | 63003 | France |
| Research Site | Dijon | 21079 | France |
| Research Site | Le Mans | 72000 | France |
| Research Site | Limoges | 87042 | France |
| Research Site | Lyon | 69373 | France |
| Research Site | Lyon | 69437 | France |
| Research Site | Marseille | 13385 | France |
| Research Site | Montpellier | 34298 | France |
| Research Site | Nice | 06189 | France |
| Research Site | Périgueux | 24004 | France |
| Research Site | Saint-Priest-en-Jarez | 42270 | France |
| Research Site | Strasbourg | 67000 | France |
| Research Site | Berlin | 13125 | Germany |
| Research Site | Bielefeld | 33611 | Germany |
| Research Site | Dresden | 01307 | Germany |
| Research Site | Essen | 45276 | Germany |
| Research Site | Frankfurt am Main | 60488 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Magdeburg | 39104 | Germany |
| Research Site | Mainz | 55131 | Germany |
| Research Site | München | 81377 | Germany |
| Research Site | München | 81737 | Germany |
| Research Site | Oldenburg | 26133 | Germany |
| Research Site | Schweinfurt | 97422 | Germany |
| Research Site | Athens | 18547 | Greece |
| Research Site | Heraklion - Crete | 71110 | Greece |
| Research Site | Larissa | 41110 | Greece |
| Research Site | Nea Kifissia, Athens | 14564 | Greece |
| Research Site | Pátrai | 26500 | Greece |
| Research Site | Thessaloniki | 54645 | Greece |
| Research Site | Thessaloniki | 56429 | Greece |
| Research Site | Budapest | 1097 | Hungary |
| Research Site | Budapest | 1106 | Hungary |
| Research Site | Győr | 9023 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Szeged | 6725 | Hungary |
| Research Site | Szolnok | 5000 | Hungary |
| Research Site | Aviano PN | 33081 | Italy |
| Research Site | Brescia | 25124 | Italy |
| Research Site | Catania | 95122 | Italy |
| Research Site | Florence | 50134 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Pisa | 56126 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Distrito Federal | Mexico City | 04380 | Mexico |
| Research Site | Mexico City | Mexico City | 14000 | Mexico |
| Research Site | Cuernavaca | Morelos | 62290 | Mexico |
| Research Site | Toluca | State of Mexico | 50080 | Mexico |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Elblag | 82-300 | Poland |
| Research Site | Gdansk | 80-219 | Poland |
| Research Site | Konin | 62-500 | Poland |
| Research Site | Lodz | 93-513 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Aveiro | 3814-501 | Portugal |
| Research Site | Guimarães | 4835-044 | Portugal |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Porto | 4200-072 | Portugal |
| Research Site | Santa Maria da Feira | 4520-211 | Portugal |
| Research Site | Vila Real | 5000-508 | Portugal |
| Research Site | Alba Iulia | 510077 | Romania |
| Research Site | Baia Mare | 430241 | Romania |
| Research Site | Brasov | 500091 | Romania |
| Research Site | Bucharest | 010719 | Romania |
| Research Site | Bucharest | 011461 | Romania |
| Research Site | Bucharest | 022328 | Romania |
| Research Site | Cluj-Napoca | 400015 | Romania |
| Research Site | Cluj-Napoca | 400058 | Romania |
| Research Site | Lasi | 700106 | Romania |
| Research Site | Timișoara | 300167 | Romania |
| Research Site | Chelyabinsk | 454087 | Russia |
| Research Site | Ivanovo | 153013 | Russia |
| Research Site | Kazan' | 420029 | Russia |
| Research Site | Krasnodar | 350040 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Samara | 443031 | Russia |
| Research Site | Vladimir | 600020 | Russia |
| Research Site | Bardejov | 085 01 | Slovakia |
| Research Site | Bratislava | 833 10 | Slovakia |
| Research Site | Poprad | 058 01 | Slovakia |
| Research Site | Trenčín | 911 71 | Slovakia |
| Research Site | Groenkloof | Gauteng | 0181 | South Africa |
| Research Site | Cape Town | 7925 | South Africa |
| Research Site | Johannesburg | 2193 | South Africa |
| Research Site | Kraaifontein | 7570 | South Africa |
| Research Site | Pretoria | 0002 | South Africa |
| Research Site | Barcelona | Catalonia | 08035 | Spain |
| Research Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Research Site | Terrassa | Catalonia | 08221 | Spain |
| Research Site | A Coruña | Galicia | 15006 | Spain |
| Research Site | Madrid | Madrid | 28050 | Spain |
| Research Site | Pamplona | Navarre | 31008 | Spain |
| Research Site | Oviedo | Principality of Asturias | 33011 | Spain |
| Research Site | Eskilstuna | 631 88 | Sweden |
| Research Site | Stockholm | 171 76 | Sweden |
| Research Site | Bellinzona | 6500 | Switzerland |
| Research Site | Bern | 3010 | Switzerland |
| Research Site | Chur | 7000 | Switzerland |
| Research Site | Ankara | 06100 | Turkey (Türkiye) |
| Research Site | Gaziantep | 27100 | Turkey (Türkiye) |
| Research Site | Istanbul | 34390 | Turkey (Türkiye) |
| Research Site | Izmir | 35100 | Turkey (Türkiye) |
| Research Site | Dnipropetrovsk | 49102 | Ukraine |
| Research Site | Kharkiv | 61070 | Ukraine |
| Research Site | Kherson | 73035 | Ukraine |
| Research Site | Kyiv | 03115 | Ukraine |
| Research Site | Lutsk | 43018 | Ukraine |
| Research Site | Lviv | 79031 | Ukraine |
| Research Site | Mariupol | 87500 | Ukraine |
| Research Site | Sumy | 40022 | Ukraine |
| Research Site | Uzhhorod | 88000 | Ukraine |
| Research Site | Belfast | BT9 7AB | United Kingdom |
| Research Site | Edinburgh | EH4 2XU | United Kingdom |
| Research Site | Guildford | GU2 7XX | United Kingdom |
| Research Site | Leicester | LE1 5WW | United Kingdom |
| Research Site | London | NW1 2PQ | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | London | SW3 6JJ | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Research Site | Northwood | HA6 2RN | United Kingdom |
| Research Site | Salisbury | SP2 8BJ | United Kingdom |
| Research Site | Sutton | SM2 5PT | United Kingdom |
| 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C524459 | rilotumumab |
| D015251 | Epirubicin |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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