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Gastric CancerPhase 3RILOMET-1NCT01697072

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

A Phase 3 study testing Rilotumumab, Epirubicin and Cisplatin in people with Gastric Cancer, run by Amgen at 189 sites in 27 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Gastric Cancer
What is being tested?
Rilotumumab, Epirubicin and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
609 participants
Where
189 sitesin 27 countries
Study dates
Oct 2012to Aug 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%

Trial locations and contacts

189 sites in 27 countries.

189 sites in 27 countries

United States16 sites

  • Research Site

    Aurora, Colorado, 80045

  • Research Site

    Baltimore, Maryland, 21231

  • Research Site

    Bedford, Texas, 76022

  • Research Site

    Chicago, Illinois, 60637

  • Research Site

    Dallas, Texas, 75246

  • Research Site

    Greensboro, North Carolina, 27403

  • Research Site

    Henderson, Nevada, 89052

  • Research Site

    Nashville, Tennessee, 37232

  • Research Site

    New York, New York, 10065

  • Research Site

    Pittsburgh, Pennsylvania, 15232

  • Research Site

    Pueblo, Colorado, 81008

  • Research Site

    Rochester, New York, 14642

  • Research Site

    Seattle, Washington, 98109

  • Research Site

    Tucson, Arizona, 85724

  • Research Site

    Winston-Salem, North Carolina, 27103

  • Research Site

    Woodbury, Minnesota, 55125

Other trials in United States

France14 sites

  • Research Site

    Bayonne, 64109

  • Research Site

    Bordeaux, 33075

  • Research Site

    Clermont-Ferrand, 63003

  • Research Site

    Dijon, 21079

  • Research Site

    Le Mans, 72000

  • Research Site

    Limoges, 87042

  • Research Site

    Lyon, 69373

  • Research Site

    Lyon, 69437

  • Research Site

    Marseille, 13385

  • Research Site

    Montpellier, 34298

  • Research Site

    Nice, 06189

  • Research Site

    Périgueux, 24004

  • Research Site

    Saint-Priest-en-Jarez, 42270

  • Research Site

    Strasbourg, 67000

Other trials in France

Germany12 sites

  • Research Site

    Berlin, 13125

  • Research Site

    Bielefeld, 33611

  • Research Site

    Dresden, 01307

  • Research Site

    Essen, 45276

  • Research Site

    Frankfurt am Main, 60488

  • Research Site

    Leipzig, 04103

  • Research Site

    Magdeburg, 39104

  • Research Site

    Mainz, 55131

  • Research Site

    München, 81377

  • Research Site

    München, 81737

  • Research Site

    Oldenburg, 26133

  • Research Site

    Schweinfurt, 97422

Other trials in Germany

United Kingdom12 sites

  • Research Site

    Belfast, BT9 7AB

  • Research Site

    Edinburgh, EH4 2XU

  • Research Site

    Guildford, GU2 7XX

  • Research Site

    Leicester, LE1 5WW

  • Research Site

    London, NW1 2PQ

  • Research Site

    London, SE1 9RT

  • Research Site

    London, SW3 6JJ

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Newcastle upon Tyne, NE7 7DN

  • Research Site

    Northwood, HA6 2RN

  • Research Site

    Salisbury, SP2 8BJ

  • Research Site

    Sutton, SM2 5PT

Other trials in United Kingdom

Romania10 sites

  • Research Site

    Alba Iulia, 510077

  • Research Site

    Baia Mare, 430241

  • Research Site

    Brasov, 500091

  • Research Site

    Bucharest, 010719

  • Research Site

    Bucharest, 011461

  • Research Site

    Bucharest, 022328

  • Research Site

    Cluj-Napoca, 400015

  • Research Site

    Cluj-Napoca, 400058

  • Research Site

    Lasi, 700106

  • Research Site

    Timișoara, 300167

Other trials in Romania

Ukraine9 sites

  • Research Site

    Dnipropetrovsk, 49102

  • Research Site

    Kharkiv, 61070

  • Research Site

    Kherson, 73035

  • Research Site

    Kyiv, 03115

  • Research Site

    Lutsk, 43018

  • Research Site

    Lviv, 79031

  • Research Site

    Mariupol, 87500

  • Research Site

    Sumy, 40022

  • Research Site

    Uzhhorod, 88000

Other trials in Ukraine

Australia8 sites

  • Research Site

    Douglas, Queensland, 4814

  • Research Site

    Elizabeth Vale, South Australia, 5112

  • Research Site

    Heidelberg, Victoria, 3084

  • Research Site

    Kurralta Park, South Australia, 5037

  • Research Site

    Randwick, New South Wales, 2031

  • Research Site

    Ringwood East, Victoria, 3135

  • Research Site

    St Leonards, New South Wales, 2065

  • Research Site

    Tweed Heads, New South Wales, 2485

Other trials in Australia

Russia8 sites

  • Research Site

    Chelyabinsk, 454087

  • Research Site

    Ivanovo, 153013

  • Research Site

    Kazan', 420029

  • Research Site

    Krasnodar, 350040

  • Research Site

    Moscow, 115478

  • Research Site

    Saint Petersburg, 197758

  • Research Site

    Samara, 443031

  • Research Site

    Vladimir, 600020

Other trials in Russia

Bulgaria7 sites

  • Research Site

    Plovdiv, 4000

  • Research Site

    Shumen, 9700

  • Research Site

    Sofia, 1233

  • Research Site

    Sofia, 1527

  • Research Site

    Sofia, 1606

  • Research Site

    Sofia, 1756

  • Research Site

    Varna, 9010

Other trials in Bulgaria

Greece7 sites

  • Research Site

    Athens, 18547

  • Research Site

    Heraklion - Crete, 71110

  • Research Site

    Larissa, 41110

  • Research Site

    Nea Kifissia, Athens, 14564

  • Research Site

    Pátrai, 26500

  • Research Site

    Thessaloniki, 54645

  • Research Site

    Thessaloniki, 56429

Other trials in Greece

Italy7 sites

  • Research Site

    Aviano PN, 33081

  • Research Site

    Brescia, 25124

  • Research Site

    Catania, 95122

  • Research Site

    Florence, 50134

  • Research Site

    Naples, 80131

  • Research Site

    Pisa, 56126

  • Research Site

    Roma, 00168

Other trials in Italy

Spain7 sites

  • Research Site

    A Coruña, Galicia, 15006

  • Research Site

    Barcelona, Catalonia, 08035

  • Research Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Research Site

    Madrid, Madrid, 28050

  • Research Site

    Oviedo, Principality of Asturias, 33011

  • Research Site

    Pamplona, Navarre, 31008

  • Research Site

    Terrassa, Catalonia, 08221

Other trials in Spain

Belgium6 sites

  • Research Site

    Brussels, 1180

  • Research Site

    Brussels, 1200

  • Research Site

    Charleroi, 6000

  • Research Site

    Edegem, 2650

  • Research Site

    Liège, 4000

  • Research Site

    Roeselare, 8800

Other trials in Belgium

Brazil6 sites

  • Research Site

    Belo Horizonte, Minas Gerais, 30150-321

  • Research Site

    Pelotas, Rio Grande do Sul, 96015-280

  • Research Site

    Santo André, São Paulo, 09060-650

  • Research Site

    São Paulo, São Paulo, 01209-000

  • Research Site

    São Paulo, São Paulo, 01246-000

  • Research Site

    São Paulo, São Paulo, 01509-900

Other trials in Brazil

Canada6 sites

  • Research Site

    Greenfield Park, Quebec, J4V 2H1

  • Research Site

    Laval, Quebec, H7M 3L9

  • Research Site

    London, Ontario, N6A 4L6

  • Research Site

    Montreal, Quebec, H2L 4M1

  • Research Site

    Toronto, Ontario, M4C 3E7

  • Research Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Hungary6 sites

  • Research Site

    Budapest, 1097

  • Research Site

    Budapest, 1106

  • Research Site

    Győr, 9023

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Szeged, 6725

  • Research Site

    Szolnok, 5000

Other trials in Hungary

Poland6 sites

  • Research Site

    Bialystok, 15-027

  • Research Site

    Elblag, 82-300

  • Research Site

    Gdansk, 80-219

  • Research Site

    Konin, 62-500

  • Research Site

    Lodz, 93-513

  • Research Site

    Warsaw, 02-781

Other trials in Poland

Portugal6 sites

  • Research Site

    Aveiro, 3814-501

  • Research Site

    Guimarães, 4835-044

  • Research Site

    Lisbon, 1649-035

  • Research Site

    Porto, 4200-072

  • Research Site

    Santa Maria da Feira, 4520-211

  • Research Site

    Vila Real, 5000-508

Other trials in Portugal

Austria5 sites

  • Research Site

    Graz, 8036

  • Research Site

    Innsbruck, 6020

  • Research Site

    Linz, 4010

  • Research Site

    Salzburg, 5020

  • Research Site

    Vienna, 1090

Other trials in Austria

Czechia5 sites

  • Research Site

    Hořovice, 268 31

  • Research Site

    Hradec Králové, 500 05

  • Research Site

    Olomouc, 775 20

  • Research Site

    Prague, 120 00

  • Research Site

    Ústí nad Labem, 401 13

Other trials in Czechia

South Africa5 sites

  • Research Site

    Cape Town, 7925

  • Research Site

    Groenkloof, Gauteng, 0181

  • Research Site

    Johannesburg, 2193

  • Research Site

    Kraaifontein, 7570

  • Research Site

    Pretoria, 0002

Other trials in South Africa

Denmark4 sites

  • Research Site

    Aalborg, 9000

  • Research Site

    Århus C, 8000

  • Research Site

    Copenhagen, 2100

  • Research Site

    Odense, 5000

Other trials in Denmark

Mexico4 sites

  • Research Site

    Cuernavaca, Morelos, 62290

  • Research Site

    Distrito Federal, Mexico City, 04380

  • Research Site

    Mexico City, Mexico City, 14000

  • Research Site

    Toluca, State of Mexico, 50080

Other trials in Mexico

Slovakia4 sites

  • Research Site

    Bardejov, 085 01

  • Research Site

    Bratislava, 833 10

  • Research Site

    Poprad, 058 01

  • Research Site

    Trenčín, 911 71

Other trials in Slovakia

Turkey (Türkiye)4 sites

  • Research Site

    Ankara, 06100

  • Research Site

    Gaziantep, 27100

  • Research Site

    Istanbul, 34390

  • Research Site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Switzerland3 sites

  • Research Site

    Bellinzona, 6500

  • Research Site

    Bern, 3010

  • Research Site

    Chur, 7000

Other trials in Switzerland

Sweden2 sites

  • Research Site

    Eskilstuna, 631 88

  • Research Site

    Stockholm, 171 76

Other trials in Sweden

About this study

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

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

Conditions
Gastric Cancer
Being tested
Rilotumumab, Placebo, Epirubicin, Cisplatin, Capecitabine
Keywords
Gastric Cancer, First Line Treatment Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer (GEJ), GEJ Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RilotumumabDrug

    Also called AMG102

    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.

  • PlaceboOther

    Also called sterile protein-free solution

    Placebo

  • EpirubicinDrug

    Also called Ellence, Pharmorubicin PFS, Pharmorubicin RDF

    Epirubicin is an anthracycline cytotoxic agent.

  • CisplatinDrug

    Also called Platinol, Platinol-AQ

    Cisplatin is a non-cell cycle specific chemotherapeutic agent.

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine is an oral fluoropyrimidine.

Study groups in NCT01697072
Study groupRoleWhat they receive
RilotumumabExperimentalRilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Receives: Drug: Rilotumumab; Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine
PlaceboPlacebo comparatorRilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Receives: Other: Placebo; Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 years

Secondary outcomes (7)

  1. PFS

    Progression Free Survival (PFS)

    Measured: 3 years

  2. TTP

    Time to Progression (TTP)

    Measured: 3 years

  3. ORR

    Objective Response Rate (ORR)

    Measured: 3 years

  4. DCR

    Disease Control Rate (DCR)

    Measured: 3 years

  5. TTR

    Time to Response (TTR)

    Measured: 3 years

  6. Safety

    Measured: 3 years

  7. Immunogenicity

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionNov 2014
  4. Study completionAug 2015

Why it stopped: All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
609 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01697072
Sponsor's protocol ID
20070622
Other IDs
2011-004923-11
Acronym
RILOMET-1
Status last verified
Jan 2016
First submitted
26 Sep 2012
Last updated
9 Feb 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 28958504

  • 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.

    PubMed 25712685

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rilotumumab, Epirubicin and Cisplatin in people with Gastric Cancer, run by Amgen at 189 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, France, Germany, United Kingdom, Romania and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01697072, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.

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