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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - 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
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
PFS - Progression Free Survival (PFS)
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
TTP - Time to Progression (TTP)
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
ORR - Objective Response Rate (ORR)
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
DCR - Disease Control Rate (DCR)
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
TTR - Time to Response (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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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/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/show/NCT01697072