First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma

Gastric Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01697072
• Other study ID #: 20070622
• Secondary ID: 2011-004923-11
• Status: Terminated
• Phase: Phase 3
• First received: September 26, 2012
• Last updated: January 18, 2016
• Start date: October 2012
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 609
• Est. completion date: August 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Stomach Neoplasms

Intervention

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:
• Placebo
Placebo

Drug:
• Epirubicin
Epirubicin is an anthracycline cytotoxic agent.
• Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
• Capecitabine
Capecitabine is an oral fluoropyrimidine.

Locations

Country	Name	City	State
Australia	Research Site	Douglas	Queensland
Australia	Research Site	Elizabeth Vale	South Australia
Australia	Research Site	Heidelberg	Victoria
Australia	Research Site	Kurralta Park	South Australia
Australia	Research Site	Randwick	New South Wales
Australia	Research Site	Ringwood East	Victoria
Australia	Research Site	St Leonards	New South Wales
Australia	Research Site	Tweed Heads	New South Wales
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	Wien
Belgium	Research Site	Bruxelles
Belgium	Research Site	Bruxelles
Belgium	Research Site	Charleroi
Belgium	Research Site	Edegem
Belgium	Research Site	Liege
Belgium	Research Site	Roeselare
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Pelotas	Rio Grande do Sul
Brazil	Research Site	Santo Andre	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	São Paulo
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Shumen
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Laval	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Czech Republic	Research Site	Horovice
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Usti nad Labem
Denmark	Research Site	Aalborg
Denmark	Research Site	Århus C
Denmark	Research Site	Copenhagen
Denmark	Research Site	Odense
France	Research Site	Bayonne
France	Research Site	Bordeaux
France	Research Site	Clermont Ferrand Cedex 1
France	Research Site	Dijon cedex
France	Research Site	Le Mans
France	Research Site	Limoges Cedex
France	Research Site	Lyon Cedex 03
France	Research Site	Lyon Cedex 08
France	Research Site	Marseille cedex 5
France	Research Site	Montpellier Cedex 5
France	Research Site	Nice cedex 2
France	Research Site	Périgueux cedex
France	Research Site	Saint Priest en Jarez
France	Research Site	Saint Priest en Jarez Cedex
France	Research Site	Strasbourg
Germany	Research Site	Berlin
Germany	Research Site	Bielefeld
Germany	Research Site	Dresden
Germany	Research Site	Essen
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Leipzig
Germany	Research Site	Magdeburg
Germany	Research Site	Mainz
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	Oldenburg
Germany	Research Site	Schweinfurt
Greece	Research Site	Athens
Greece	Research Site	Heraklion - Crete
Greece	Research Site	Larissa
Greece	Research Site	Nea Kifissia, Athens
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szeged
Hungary	Research Site	Szolnok
Italy	Research Site	Aviano PN
Italy	Research Site	Brescia
Italy	Research Site	Catania
Italy	Research Site	Firenze
Italy	Research Site	Napoli
Italy	Research Site	Pisa
Italy	Research Site	Roma
Mexico	Research Site	Cuernavaca	Morelos
Mexico	Research Site	Distrito Federal
Mexico	Research Site	Mexico	Distrito Federal
Mexico	Research Site	Toluca
Poland	Research Site	Bialystok
Poland	Research Site	Elblag
Poland	Research Site	Gdansk
Poland	Research Site	Konin
Poland	Research Site	Lodz
Poland	Research Site	Warszawa
Portugal	Research Site	Aveiro
Portugal	Research Site	Guimaraes
Portugal	Research Site	Lisboa
Portugal	Research Site	Porto
Portugal	Research Site	Santa Maria da Feira
Portugal	Research Site	Vila Real
Romania	Research Site	Alba Iulia
Romania	Research Site	Baia Mare
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Cluj Napoca
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Lasi
Romania	Research Site	Timisoara
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ivanovo
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Vladimir
Slovakia	Research Site	Bardejov
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Poprad
Slovakia	Research Site	Trencin
South Africa	Research Site	Cape Town
South Africa	Research Site	Groenkloof	Gauteng
South Africa	Research Site	Johannesburg
South Africa	Research Site	Kraaifontein
South Africa	Research Site	Pretoria
Spain	Research Site	A Coruña	Galicia
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	L'Hospitalet de Llobregat	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Pamplona	Navarra
Spain	Research Site	Terrassa	Cataluña
Sweden	Research Site	Eskilstuna
Sweden	Research Site	Stockholm
Switzerland	Research Site	Bellinzona
Switzerland	Research Site	Bern
Switzerland	Research Site	Chur
Turkey	Research Site	Ankara
Turkey	Research Site	Gaziantep
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kherson
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lutsk
Ukraine	Research Site	Lviv
Ukraine	Research Site	Mariupol
Ukraine	Research Site	Sumy
Ukraine	Research Site	Uzhgorod
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Guildford
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Newcastle Upon Tyne
United Kingdom	Research Site	Northwood
United Kingdom	Research Site	Salisbury
United Kingdom	Research Site	Sutton
United States	Research Site	Aurora	Colorado
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bedford	Texas
United States	Research Site	Chicago	Illinois
United States	Research Site	Dallas	Texas
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Henderson	Nevada
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pueblo	Colorado
United States	Research Site	Rochester	New York
United States	Research Site	Seattle	Washington
United States	Research Site	Tucson	Arizona
United States	Research Site	Winston Salem	North Carolina
United States	Research Site	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Mexico,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	PFS	Progression Free Survival (PFS)	3 years	Yes
Secondary	TTP	Time to Progression (TTP)	3 years	Yes
Secondary	ORR	Objective Response Rate (ORR)	3 years	Yes
Secondary	DCR	Disease Control Rate (DCR)	3 years	Yes
Secondary	TTR	Time to Response (TTR)	3 years	Yes
Secondary	Safety		3 years	Yes
Secondary	Immunogenicity		3 years	Yes

External Links

•   AmgenTrials clinical trials website