Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01697072




Registration number
NCT01697072
Ethics application status
Date submitted
26/09/2012
Date registered
2/10/2012
Date last updated
9/02/2016

Titles & IDs
Public title
First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma
Scientific 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
Secondary ID [1] 0 0
2011-004923-11
Secondary ID [2] 0 0
20070622
Universal Trial Number (UTN)
Trial acronym
RILOMET-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rilotumumab
Other interventions - Placebo
Treatment: Drugs - Epirubicin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Capecitabine

Experimental: Rilotumumab - Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)

Placebo Comparator: Placebo - Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)


Treatment: Drugs: 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 interventions: Placebo
Placebo

Treatment: Drugs: Epirubicin
Epirubicin is an anthracycline cytotoxic agent.

Treatment: Drugs: Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.

Treatment: Drugs: Capecitabine
Capecitabine is an oral fluoropyrimidine.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
PFS
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
TTP
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
ORR
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
DCR
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
TTR
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Safety
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Immunogenicity
Timepoint [7] 0 0
3 years

Eligibility
Key inclusion criteria
Key

- 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%
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
609
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Randwick
Recruitment hospital [2] 0 0
Research Site - St Leonards
Recruitment hospital [3] 0 0
Research Site - Tweed Heads
Recruitment hospital [4] 0 0
Research Site - Douglas
Recruitment hospital [5] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [6] 0 0
Research Site - Kurralta Park
Recruitment hospital [7] 0 0
Research Site - Heidelberg
Recruitment hospital [8] 0 0
Research Site - Ringwood East
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3135 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Austria
State/province [13] 0 0
Graz
Country [14] 0 0
Austria
State/province [14] 0 0
Innsbruck
Country [15] 0 0
Austria
State/province [15] 0 0
Linz
Country [16] 0 0
Austria
State/province [16] 0 0
Salzburg
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Belgium
State/province [18] 0 0
Bruxelles
Country [19] 0 0
Belgium
State/province [19] 0 0
Charleroi
Country [20] 0 0
Belgium
State/province [20] 0 0
Edegem
Country [21] 0 0
Belgium
State/province [21] 0 0
Liege
Country [22] 0 0
Belgium
State/province [22] 0 0
Roeselare
Country [23] 0 0
Brazil
State/province [23] 0 0
Minas Gerais
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande do Sul
Country [25] 0 0
Brazil
State/province [25] 0 0
São Paulo
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Plovdiv
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Shumen
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Varna
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Horovice
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Hradec Kralove
Country [35] 0 0
Czech Republic
State/province [35] 0 0
Olomouc
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Praha 2
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Usti nad Labem
Country [38] 0 0
Denmark
State/province [38] 0 0
Aalborg
Country [39] 0 0
Denmark
State/province [39] 0 0
Copenhagen
Country [40] 0 0
Denmark
State/province [40] 0 0
Odense
Country [41] 0 0
Denmark
State/province [41] 0 0
Århus C
Country [42] 0 0
France
State/province [42] 0 0
Bayonne
Country [43] 0 0
France
State/province [43] 0 0
Bordeaux
Country [44] 0 0
France
State/province [44] 0 0
Clermont Ferrand Cedex 1
Country [45] 0 0
France
State/province [45] 0 0
Dijon cedex
Country [46] 0 0
France
State/province [46] 0 0
Le Mans
Country [47] 0 0
France
State/province [47] 0 0
Limoges Cedex
Country [48] 0 0
France
State/province [48] 0 0
Lyon Cedex 03
Country [49] 0 0
France
State/province [49] 0 0
Lyon Cedex 08
Country [50] 0 0
France
State/province [50] 0 0
Marseille cedex 5
Country [51] 0 0
France
State/province [51] 0 0
Montpellier Cedex 5
Country [52] 0 0
France
State/province [52] 0 0
Nice cedex 2
Country [53] 0 0
France
State/province [53] 0 0
Périgueux cedex
Country [54] 0 0
France
State/province [54] 0 0
Saint Priest en Jarez Cedex
Country [55] 0 0
France
State/province [55] 0 0
Saint Priest en Jarez
Country [56] 0 0
France
State/province [56] 0 0
Strasbourg
Country [57] 0 0
Germany
State/province [57] 0 0
Berlin
Country [58] 0 0
Germany
State/province [58] 0 0
Bielefeld
Country [59] 0 0
Germany
State/province [59] 0 0
Dresden
Country [60] 0 0
Germany
State/province [60] 0 0
Essen
Country [61] 0 0
Germany
State/province [61] 0 0
Frankfurt am Main
Country [62] 0 0
Germany
State/province [62] 0 0
Leipzig
Country [63] 0 0
Germany
State/province [63] 0 0
Magdeburg
Country [64] 0 0
Germany
State/province [64] 0 0
Mainz
Country [65] 0 0
Germany
State/province [65] 0 0
München
Country [66] 0 0
Germany
State/province [66] 0 0
Oldenburg
Country [67] 0 0
Germany
State/province [67] 0 0
Schweinfurt
Country [68] 0 0
Greece
State/province [68] 0 0
Athens
Country [69] 0 0
Greece
State/province [69] 0 0
Heraklion - Crete
Country [70] 0 0
Greece
State/province [70] 0 0
Larissa
Country [71] 0 0
Greece
State/province [71] 0 0
Nea Kifissia, Athens
Country [72] 0 0
Greece
State/province [72] 0 0
Patra
Country [73] 0 0
Greece
State/province [73] 0 0
Thessaloniki
Country [74] 0 0
Hungary
State/province [74] 0 0
Budapest
Country [75] 0 0
Hungary
State/province [75] 0 0
Gyor
Country [76] 0 0
Hungary
State/province [76] 0 0
Nyiregyhaza
Country [77] 0 0
Hungary
State/province [77] 0 0
Szeged
Country [78] 0 0
Hungary
State/province [78] 0 0
Szolnok
Country [79] 0 0
Italy
State/province [79] 0 0
Aviano PN
Country [80] 0 0
Italy
State/province [80] 0 0
Brescia
Country [81] 0 0
Italy
State/province [81] 0 0
Catania
Country [82] 0 0
Italy
State/province [82] 0 0
Firenze
Country [83] 0 0
Italy
State/province [83] 0 0
Napoli
Country [84] 0 0
Italy
State/province [84] 0 0
Pisa
Country [85] 0 0
Italy
State/province [85] 0 0
Roma
Country [86] 0 0
Mexico
State/province [86] 0 0
Distrito Federal
Country [87] 0 0
Mexico
State/province [87] 0 0
Morelos
Country [88] 0 0
Mexico
State/province [88] 0 0
Toluca
Country [89] 0 0
Poland
State/province [89] 0 0
Bialystok
Country [90] 0 0
Poland
State/province [90] 0 0
Elblag
Country [91] 0 0
Poland
State/province [91] 0 0
Gdansk
Country [92] 0 0
Poland
State/province [92] 0 0
Konin
Country [93] 0 0
Poland
State/province [93] 0 0
Lodz
Country [94] 0 0
Poland
State/province [94] 0 0
Warszawa
Country [95] 0 0
Portugal
State/province [95] 0 0
Aveiro
Country [96] 0 0
Portugal
State/province [96] 0 0
Guimaraes
Country [97] 0 0
Portugal
State/province [97] 0 0
Lisboa
Country [98] 0 0
Portugal
State/province [98] 0 0
Porto
Country [99] 0 0
Portugal
State/province [99] 0 0
Santa Maria da Feira
Country [100] 0 0
Portugal
State/province [100] 0 0
Vila Real
Country [101] 0 0
Romania
State/province [101] 0 0
Alba Iulia
Country [102] 0 0
Romania
State/province [102] 0 0
Baia Mare
Country [103] 0 0
Romania
State/province [103] 0 0
Brasov
Country [104] 0 0
Romania
State/province [104] 0 0
Bucharest
Country [105] 0 0
Romania
State/province [105] 0 0
Cluj Napoca
Country [106] 0 0
Romania
State/province [106] 0 0
Cluj-Napoca
Country [107] 0 0
Romania
State/province [107] 0 0
Lasi
Country [108] 0 0
Romania
State/province [108] 0 0
Timisoara
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Chelyabinsk
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Ivanovo
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Kazan
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Krasnodar
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Moscow
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Saint-Petersburg
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Samara
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Vladimir
Country [117] 0 0
Slovakia
State/province [117] 0 0
Bardejov
Country [118] 0 0
Slovakia
State/province [118] 0 0
Bratislava
Country [119] 0 0
Slovakia
State/province [119] 0 0
Poprad
Country [120] 0 0
Slovakia
State/province [120] 0 0
Trencin
Country [121] 0 0
South Africa
State/province [121] 0 0
Gauteng
Country [122] 0 0
South Africa
State/province [122] 0 0
Cape Town
Country [123] 0 0
South Africa
State/province [123] 0 0
Johannesburg
Country [124] 0 0
South Africa
State/province [124] 0 0
Kraaifontein
Country [125] 0 0
South Africa
State/province [125] 0 0
Pretoria
Country [126] 0 0
Spain
State/province [126] 0 0
Asturias
Country [127] 0 0
Spain
State/province [127] 0 0
Cataluña
Country [128] 0 0
Spain
State/province [128] 0 0
Galicia
Country [129] 0 0
Spain
State/province [129] 0 0
Navarra
Country [130] 0 0
Spain
State/province [130] 0 0
Madrid
Country [131] 0 0
Sweden
State/province [131] 0 0
Eskilstuna
Country [132] 0 0
Sweden
State/province [132] 0 0
Stockholm
Country [133] 0 0
Switzerland
State/province [133] 0 0
Bellinzona
Country [134] 0 0
Switzerland
State/province [134] 0 0
Bern
Country [135] 0 0
Switzerland
State/province [135] 0 0
Chur
Country [136] 0 0
Turkey
State/province [136] 0 0
Ankara
Country [137] 0 0
Turkey
State/province [137] 0 0
Gaziantep
Country [138] 0 0
Turkey
State/province [138] 0 0
Istanbul
Country [139] 0 0
Turkey
State/province [139] 0 0
Izmir
Country [140] 0 0
Ukraine
State/province [140] 0 0
Dnipropetrovsk
Country [141] 0 0
Ukraine
State/province [141] 0 0
Kharkiv
Country [142] 0 0
Ukraine
State/province [142] 0 0
Kherson
Country [143] 0 0
Ukraine
State/province [143] 0 0
Kyiv
Country [144] 0 0
Ukraine
State/province [144] 0 0
Lutsk
Country [145] 0 0
Ukraine
State/province [145] 0 0
Lviv
Country [146] 0 0
Ukraine
State/province [146] 0 0
Mariupol
Country [147] 0 0
Ukraine
State/province [147] 0 0
Sumy
Country [148] 0 0
Ukraine
State/province [148] 0 0
Uzhgorod
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Belfast
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Edinburgh
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Guildford
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Leicester
Country [153] 0 0
United Kingdom
State/province [153] 0 0
London
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Manchester
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Newcastle Upon Tyne
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Northwood
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Salisbury
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01697072
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01697072