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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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0
2011-004923-11
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Secondary ID [2]
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0
20070622
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Universal Trial Number (UTN)
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Trial acronym
RILOMET-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Stomach
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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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
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Timepoint [1]
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3 years
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Secondary outcome [1]
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PFS
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Assessment method [1]
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Progression Free Survival (PFS)
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Timepoint [1]
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3 years
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Secondary outcome [2]
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TTP
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Assessment method [2]
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Time to Progression (TTP)
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Timepoint [2]
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3 years
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Secondary outcome [3]
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ORR
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Assessment method [3]
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Objective Response Rate (ORR)
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Timepoint [3]
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3 years
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Secondary outcome [4]
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DCR
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Assessment method [4]
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Disease Control Rate (DCR)
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Timepoint [4]
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3 years
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Secondary outcome [5]
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TTR
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Assessment method [5]
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Time to Response (TTR)
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Timepoint [5]
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3 years
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Secondary outcome [6]
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Safety
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Assessment method [6]
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0
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Timepoint [6]
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3 years
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Secondary outcome [7]
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Immunogenicity
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Assessment method [7]
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0
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Timepoint [7]
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3 years
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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%
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2015
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Sample size
Target
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Accrual to date
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Final
609
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Randwick
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Research Site - St Leonards
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Research Site - Douglas
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Research Site - Elizabeth Vale
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Research Site - Kurralta Park
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Research Site - Heidelberg
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Recruitment hospital [8]
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Research Site - Ringwood East
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2485 - Tweed Heads
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Recruitment postcode(s) [4]
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4814 - Douglas
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Recruitment postcode(s) [5]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [6]
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5037 - Kurralta Park
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Recruitment postcode(s) [7]
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3084 - Heidelberg
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Recruitment postcode(s) [8]
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3135 - Ringwood East
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Recruitment outside Australia
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United States of America
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Arizona
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Colorado
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Kraaifontein
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Pretoria
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Asturias
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Cataluña
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Spain
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Galicia
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Madrid
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Bern
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Chur
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Turkey
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Ankara
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Turkey
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Gaziantep
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Istanbul
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Turkey
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Izmir
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Mariupol
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Ukraine
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Sumy
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Ukraine
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Uzhgorod
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United Kingdom
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Belfast
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United Kingdom
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Edinburgh
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United Kingdom
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Guildford
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Northwood
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United Kingdom
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Salisbury
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Ethics approval
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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
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Trial website
https://clinicaltrials.gov/study/NCT01697072
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Trial related presentations / 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. 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.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01697072
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