RILOMET-1: First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma
Sponsor
Amgen (Industry)
Overall Status
Terminated
CT.gov ID
NCT01697072
Collaborator
(none)
609
191
2
34
3.2
0.1
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
609 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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
Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Nov 1, 2014
Actual Study Completion Date
:
Aug 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
Drug: Epirubicin
Epirubicin is an anthracycline cytotoxic agent.
Other Names:
Drug: Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Other Names:
Drug: Capecitabine
Capecitabine is an oral fluoropyrimidine.
Other Names:
|
| Placebo Comparator: Placebo Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX) |
Other: Placebo
Placebo
Other Names:
Drug: Epirubicin
Epirubicin is an anthracycline cytotoxic agent.
Other Names:
Drug: Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Other Names:
Drug: Capecitabine
Capecitabine is an oral fluoropyrimidine.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [3 years]
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 [3 years]
Progression Free Survival (PFS)
- TTP [3 years]
Time to Progression (TTP)
- ORR [3 years]
Objective Response Rate (ORR)
- DCR [3 years]
Disease Control Rate (DCR)
- TTR [3 years]
Time to Response (TTR)
- Safety [3 years]
- Immunogenicity [3 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Tucson | Arizona | United States | 85724 |
| 2 | Research Site | Aurora | Colorado | United States | 80045 |
| 3 | Research Site | Pueblo | Colorado | United States | 81008 |
| 4 | Research Site | Chicago | Illinois | United States | 60637 |
| 5 | Research Site | Baltimore | Maryland | United States | 21231 |
| 6 | Research Site | Woodbury | Minnesota | United States | 55125 |
| 7 | Research Site | Henderson | Nevada | United States | 89052 |
| 8 | Research Site | New York | New York | United States | 10065 |
| 9 | Research Site | Rochester | New York | United States | 14642 |
| 10 | Research Site | Greensboro | North Carolina | United States | 27403 |
| 11 | Research Site | Winston Salem | North Carolina | United States | 27103 |
| 12 | Research Site | Pittsburgh | Pennsylvania | United States | 15232 |
| 13 | Research Site | Nashville | Tennessee | United States | 37232 |
| 14 | Research Site | Bedford | Texas | United States | 76022 |
| 15 | Research Site | Dallas | Texas | United States | 75246 |
| 16 | Research Site | Seattle | Washington | United States | 98109 |
| 17 | Research Site | Randwick | New South Wales | Australia | 2031 |
| 18 | Research Site | St Leonards | New South Wales | Australia | 2065 |
| 19 | Research Site | Tweed Heads | New South Wales | Australia | 2485 |
| 20 | Research Site | Douglas | Queensland | Australia | 4814 |
| 21 | Research Site | Elizabeth Vale | South Australia | Australia | 5112 |
| 22 | Research Site | Kurralta Park | South Australia | Australia | 5037 |
| 23 | Research Site | Heidelberg | Victoria | Australia | 3084 |
| 24 | Research Site | Ringwood East | Victoria | Australia | 3135 |
| 25 | Research Site | Graz | Austria | 8036 | |
| 26 | Research Site | Innsbruck | Austria | 6020 | |
| 27 | Research Site | Linz | Austria | 4010 | |
| 28 | Research Site | Salzburg | Austria | 5020 | |
| 29 | Research Site | Wien | Austria | 1090 | |
| 30 | Research Site | Bruxelles | Belgium | 1180 | |
| 31 | Research Site | Bruxelles | Belgium | 1200 | |
| 32 | Research Site | Charleroi | Belgium | 6000 | |
| 33 | Research Site | Edegem | Belgium | 2650 | |
| 34 | Research Site | Liege | Belgium | 4000 | |
| 35 | Research Site | Roeselare | Belgium | 8800 | |
| 36 | Research Site | Belo Horizonte | Minas Gerais | Brazil | 30150-321 |
| 37 | Research Site | Pelotas | Rio Grande do Sul | Brazil | 96015-280 |
| 38 | Research Site | Santo Andre | São Paulo | Brazil | 09060-650 |
| 39 | Research Site | Sao Paulo | São Paulo | Brazil | 01209-000 |
| 40 | Research Site | Sao Paulo | São Paulo | Brazil | 01509-900 |
| 41 | Research Site | São Paulo | Brazil | 01246-000 | |
| 42 | Research Site | Plovdiv | Bulgaria | 4000 | |
| 43 | Research Site | Shumen | Bulgaria | 9700 | |
| 44 | Research Site | Sofia | Bulgaria | 1233 | |
| 45 | Research Site | Sofia | Bulgaria | 1527 | |
| 46 | Research Site | Sofia | Bulgaria | 1606 | |
| 47 | Research Site | Sofia | Bulgaria | 1756 | |
| 48 | Research Site | Varna | Bulgaria | 9010 | |
| 49 | Research Site | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 50 | Research Site | London | Ontario | Canada | N6A 4L6 |
| 51 | Research Site | Toronto | Ontario | Canada | M4C 3E7 |
| 52 | Research Site | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 53 | Research Site | Laval | Quebec | Canada | H7M 3L9 |
| 54 | Research Site | Montreal | Quebec | Canada | H2L 4M1 |
| 55 | Research Site | Horovice | Czech Republic | 268 31 | |
| 56 | Research Site | Hradec Kralove | Czech Republic | 500 05 | |
| 57 | Research Site | Olomouc | Czech Republic | 775 20 | |
| 58 | Research Site | Praha 2 | Czech Republic | 120 00 | |
| 59 | Research Site | Usti nad Labem | Czech Republic | 401 13 | |
| 60 | Research Site | Aalborg | Denmark | 9000 | |
| 61 | Research Site | Copenhagen | Denmark | 2100 | |
| 62 | Research Site | Odense | Denmark | 5000 | |
| 63 | Research Site | Århus C | Denmark | 8000 | |
| 64 | Research Site | Bayonne | France | 64109 | |
| 65 | Research Site | Bordeaux | France | 33075 | |
| 66 | Research Site | Clermont Ferrand Cedex 1 | France | 63003 | |
| 67 | Research Site | Dijon cedex | France | 21079 | |
| 68 | Research Site | Le Mans | France | 72000 | |
| 69 | Research Site | Limoges Cedex | France | 87042 | |
| 70 | Research Site | Lyon Cedex 03 | France | 69437 | |
| 71 | Research Site | Lyon Cedex 08 | France | 69373 | |
| 72 | Research Site | Marseille cedex 5 | France | 13385 | |
| 73 | Research Site | Montpellier Cedex 5 | France | 34298 | |
| 74 | Research Site | Nice cedex 2 | France | 06189 | |
| 75 | Research Site | Périgueux cedex | France | 24004 | |
| 76 | Research Site | Saint Priest en Jarez Cedex | France | 42270 | |
| 77 | Research Site | Saint Priest en Jarez | France | 42270 | |
| 78 | Research Site | Strasbourg | France | 67000 | |
| 79 | Research Site | Berlin | Germany | 13125 | |
| 80 | Research Site | Bielefeld | Germany | 33611 | |
| 81 | Research Site | Dresden | Germany | 01307 | |
| 82 | Research Site | Essen | Germany | 45276 | |
| 83 | Research Site | Frankfurt am Main | Germany | 60488 | |
| 84 | Research Site | Leipzig | Germany | 04103 | |
| 85 | Research Site | Magdeburg | Germany | 39104 | |
| 86 | Research Site | Mainz | Germany | 55131 | |
| 87 | Research Site | München | Germany | 81377 | |
| 88 | Research Site | München | Germany | 81737 | |
| 89 | Research Site | Oldenburg | Germany | 26133 | |
| 90 | Research Site | Schweinfurt | Germany | 97422 | |
| 91 | Research Site | Athens | Greece | 18547 | |
| 92 | Research Site | Heraklion - Crete | Greece | 71110 | |
| 93 | Research Site | Larissa | Greece | 41110 | |
| 94 | Research Site | Nea Kifissia, Athens | Greece | 14564 | |
| 95 | Research Site | Patra | Greece | 26500 | |
| 96 | Research Site | Thessaloniki | Greece | 54645 | |
| 97 | Research Site | Thessaloniki | Greece | 56429 | |
| 98 | Research Site | Budapest | Hungary | 1097 | |
| 99 | Research Site | Budapest | Hungary | 1106 | |
| 100 | Research Site | Gyor | Hungary | 9023 | |
| 101 | Research Site | Nyiregyhaza | Hungary | 4400 | |
| 102 | Research Site | Szeged | Hungary | 6725 | |
| 103 | Research Site | Szolnok | Hungary | 5000 | |
| 104 | Research Site | Aviano PN | Italy | 33081 | |
| 105 | Research Site | Brescia | Italy | 25124 | |
| 106 | Research Site | Catania | Italy | 95122 | |
| 107 | Research Site | Firenze | Italy | 50134 | |
| 108 | Research Site | Napoli | Italy | 80131 | |
| 109 | Research Site | Pisa | Italy | 56126 | |
| 110 | Research Site | Roma | Italy | 00168 | |
| 111 | Research Site | Mexico | Distrito Federal | Mexico | 14000 |
| 112 | Research Site | Cuernavaca | Morelos | Mexico | 62290 |
| 113 | Research Site | Distrito Federal | Mexico | 04380 | |
| 114 | Research Site | Toluca | Mexico | 50080 | |
| 115 | Research Site | Bialystok | Poland | 15-027 | |
| 116 | Research Site | Elblag | Poland | 82-300 | |
| 117 | Research Site | Gdansk | Poland | 80-219 | |
| 118 | Research Site | Konin | Poland | 62-500 | |
| 119 | Research Site | Lodz | Poland | 93-513 | |
| 120 | Research Site | Warszawa | Poland | 02-781 | |
| 121 | Research Site | Aveiro | Portugal | 3814-501 | |
| 122 | Research Site | Guimaraes | Portugal | 4835-044 | |
| 123 | Research Site | Lisboa | Portugal | 1649-035 | |
| 124 | Research Site | Porto | Portugal | 4200-072 | |
| 125 | Research Site | Santa Maria da Feira | Portugal | 4520-211 | |
| 126 | Research Site | Vila Real | Portugal | 5000-508 | |
| 127 | Research Site | Alba Iulia | Romania | 510077 | |
| 128 | Research Site | Baia Mare | Romania | 430241 | |
| 129 | Research Site | Brasov | Romania | 500091 | |
| 130 | Research Site | Bucharest | Romania | 010719 | |
| 131 | Research Site | Bucharest | Romania | 011461 | |
| 132 | Research Site | Bucharest | Romania | 022328 | |
| 133 | Research Site | Cluj Napoca | Romania | 400015 | |
| 134 | Research Site | Cluj-Napoca | Romania | 400015 | |
| 135 | Research Site | Cluj-Napoca | Romania | 400058 | |
| 136 | Research Site | Lasi | Romania | 700106 | |
| 137 | Research Site | Timisoara | Romania | 300167 | |
| 138 | Research Site | Chelyabinsk | Russian Federation | 454087 | |
| 139 | Research Site | Ivanovo | Russian Federation | 153013 | |
| 140 | Research Site | Kazan | Russian Federation | 420029 | |
| 141 | Research Site | Krasnodar | Russian Federation | 350040 | |
| 142 | Research Site | Moscow | Russian Federation | 115478 | |
| 143 | Research Site | Saint-Petersburg | Russian Federation | 197758 | |
| 144 | Research Site | Samara | Russian Federation | 443031 | |
| 145 | Research Site | Vladimir | Russian Federation | 600020 | |
| 146 | Research Site | Bardejov | Slovakia | 085 01 | |
| 147 | Research Site | Bratislava | Slovakia | 833 10 | |
| 148 | Research Site | Poprad | Slovakia | 058 01 | |
| 149 | Research Site | Trencin | Slovakia | 911 71 | |
| 150 | Research Site | Groenkloof | Gauteng | South Africa | 0181 |
| 151 | Research Site | Cape Town | South Africa | 7925 | |
| 152 | Research Site | Johannesburg | South Africa | 2193 | |
| 153 | Research Site | Kraaifontein | South Africa | 7570 | |
| 154 | Research Site | Pretoria | South Africa | 0002 | |
| 155 | Research Site | Oviedo | Asturias | Spain | 33011 |
| 156 | Research Site | Barcelona | Cataluña | Spain | 08035 |
| 157 | Research Site | L'Hospitalet de Llobregat | Cataluña | Spain | 08907 |
| 158 | Research Site | Terrassa | Cataluña | Spain | 08221 |
| 159 | Research Site | A Coruña | Galicia | Spain | 15006 |
| 160 | Research Site | Pamplona | Navarra | Spain | 31008 |
| 161 | Research Site | Madrid | Spain | 28050 | |
| 162 | Research Site | Eskilstuna | Sweden | 631 88 | |
| 163 | Research Site | Stockholm | Sweden | 171 76 | |
| 164 | Research Site | Bellinzona | Switzerland | 6500 | |
| 165 | Research Site | Bern | Switzerland | 3010 | |
| 166 | Research Site | Chur | Switzerland | 7000 | |
| 167 | Research Site | Ankara | Turkey | 06100 | |
| 168 | Research Site | Gaziantep | Turkey | 27100 | |
| 169 | Research Site | Istanbul | Turkey | 34390 | |
| 170 | Research Site | Izmir | Turkey | 35100 | |
| 171 | Research Site | Dnipropetrovsk | Ukraine | 49102 | |
| 172 | Research Site | Kharkiv | Ukraine | 61070 | |
| 173 | Research Site | Kherson | Ukraine | 73035 | |
| 174 | Research Site | Kyiv | Ukraine | 03115 | |
| 175 | Research Site | Lutsk | Ukraine | 43018 | |
| 176 | Research Site | Lviv | Ukraine | 79031 | |
| 177 | Research Site | Mariupol | Ukraine | 87500 | |
| 178 | Research Site | Sumy | Ukraine | 40022 | |
| 179 | Research Site | Uzhgorod | Ukraine | 88000 | |
| 180 | Research Site | Belfast | United Kingdom | BT9 7AB | |
| 181 | Research Site | Edinburgh | United Kingdom | EH4 2XU | |
| 182 | Research Site | Guildford | United Kingdom | GU2 7XX | |
| 183 | Research Site | Leicester | United Kingdom | LE1 5WW | |
| 184 | Research Site | London | United Kingdom | NW1 2PQ | |
| 185 | Research Site | London | United Kingdom | SE1 9RT | |
| 186 | Research Site | London | United Kingdom | SW3 6JJ | |
| 187 | Research Site | Manchester | United Kingdom | M20 4BX | |
| 188 | Research Site | Newcastle Upon Tyne | United Kingdom | NE7 7DN | |
| 189 | Research Site | Northwood | United Kingdom | HA6 2RN | |
| 190 | Research Site | Salisbury | United Kingdom | SP2 8BJ | |
| 191 | Research Site | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT01697072
Other Study ID Numbers:
- 20070622
- 2011-004923-11
First Posted:
Oct 2, 2012
Last Update Posted:
Feb 9, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Amgen
Additional relevant MeSH terms: