Back to resultsFirst-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma (RILOMET-1)
Primary Purpose
Gastric Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rilotumumab
Placebo
Epirubicin
Cisplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, First Line Treatment Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer (GEJ), GEJ Cancer
Eligibility 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%
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rilotumumab
Placebo
Arm Description
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
PFS
Progression Free Survival (PFS)
TTP
Time to Progression (TTP)
ORR
Objective Response Rate (ORR)
DCR
Disease Control Rate (DCR)
TTR
Time to Response (TTR)
Safety
Immunogenicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01697072
Brief Title
First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma
Acronym
RILOMET-1
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, First Line Treatment Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer (GEJ), GEJ Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
609 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rilotumumab
Arm Type
Experimental
Arm Description
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Intervention Type
Drug
Intervention Name(s)
Rilotumumab
Other Intervention Name(s)
AMG102
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
sterile protein-free solution
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
Ellence, Pharmorubicin PFS, Pharmorubicin RDF
Intervention Description
Epirubicin is an anthracycline cytotoxic agent.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol, Platinol-AQ
Intervention Description
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine is an oral fluoropyrimidine.
Primary Outcome Measure Information:
Title
Overall Survival
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival (PFS)
Time Frame
3 years
Title
TTP
Description
Time to Progression (TTP)
Time Frame
3 years
Title
ORR
Description
Objective Response Rate (ORR)
Time Frame
3 years
Title
DCR
Description
Disease Control Rate (DCR)
Time Frame
3 years
Title
TTR
Description
Time to Response (TTR)
Time Frame
3 years
Title
Safety
Time Frame
3 years
Title
Immunogenicity
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
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Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
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Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Research Site
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Research Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
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Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
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Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
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Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
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Research Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
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Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
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Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
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Research Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
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Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
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Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
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Research Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
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Australia
Facility Name
Research Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
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Australia
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Research Site
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
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Australia
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City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
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Australia
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Research Site
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
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Research Site
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Research Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Research Site
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
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City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
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City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
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City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
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City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
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City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Research Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-321
Country
Brazil
Facility Name
Research Site
City
Pelotas
State/Province
Rio Grande do Sul
ZIP/Postal Code
96015-280
Country
Brazil
Facility Name
Research Site
City
Santo Andre
State/Province
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01209-000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Research Site
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
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Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
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Research Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Research Site
City
Horovice
ZIP/Postal Code
268 31
Country
Czech Republic
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
Research Site
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Research Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Research Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Research Site
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Research Site
City
Clermont Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Research Site
City
Dijon cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Research Site
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Research Site
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Research Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Research Site
City
Marseille cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Research Site
City
Nice cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Research Site
City
Périgueux cedex
ZIP/Postal Code
24004
Country
France
Facility Name
Research Site
City
Saint Priest en Jarez Cedex
ZIP/Postal Code
42270
Country
France
Facility Name
Research Site
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Research Site
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45276
Country
Germany
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81737
Country
Germany
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Research Site
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
Research Site
City
Heraklion - Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Nea Kifissia, Athens
ZIP/Postal Code
14564
Country
Greece
Facility Name
Research Site
City
Patra
ZIP/Postal Code
26500
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Research Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Research Site
City
Aviano PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Research Site
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Research Site
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Research Site
City
Distrito Federal
ZIP/Postal Code
04380
Country
Mexico
Facility Name
Research Site
City
Toluca
ZIP/Postal Code
50080
Country
Mexico
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Research Site
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Research Site
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Research Site
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Research Site
City
Vila Real
ZIP/Postal Code
5000-508
Country
Portugal
Facility Name
Research Site
City
Alba Iulia
ZIP/Postal Code
510077
Country
Romania
Facility Name
Research Site
City
Baia Mare
ZIP/Postal Code
430241
Country
Romania
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
500091
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
010719
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Research Site
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Research Site
City
Lasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300167
Country
Romania
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Research Site
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Research Site
City
Vladimir
ZIP/Postal Code
600020
Country
Russian Federation
Facility Name
Research Site
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Research Site
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Research Site
City
Trencin
ZIP/Postal Code
911 71
Country
Slovakia
Facility Name
Research Site
City
Groenkloof
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Research Site
City
Kraaifontein
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Research Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Terrassa
State/Province
Cataluña
ZIP/Postal Code
08221
Country
Spain
Facility Name
Research Site
City
A Coruña
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Research Site
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Research Site
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Research Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Research Site
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Research Site
City
Gaziantep
ZIP/Postal Code
27100
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Research Site
City
Kherson
ZIP/Postal Code
73035
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Research Site
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Research Site
City
Mariupol
ZIP/Postal Code
87500
Country
Ukraine
Facility Name
Research Site
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Research Site
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Research Site
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW1 2PQ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Research Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Research Site
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28958504
Citation
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.
Results Reference
derived
PubMed Identifier
25712685
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma
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