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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
609
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.
Placebo
Epirubicin is an anthracycline cytotoxic agent.
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
Time frame: 3 years
PFS
Progression Free Survival (PFS)
Time frame: 3 years
TTP
Time to Progression (TTP)
Time frame: 3 years
ORR
Objective Response Rate (ORR)
Time frame: 3 years
DCR
Disease Control Rate (DCR)
Time frame: 3 years
TTR
Time to Response (TTR)
Time frame: 3 years
Safety
Time frame: 3 years
Immunogenicity
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Capecitabine is an oral fluoropyrimidine.
Research Site
Tucson, Arizona, United States
Research Site
Aurora, Colorado, United States
Research Site
Pueblo, Colorado, United States
Research Site
Chicago, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Woodbury, Minnesota, United States
Research Site
Henderson, Nevada, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Greensboro, North Carolina, United States
...and 179 more locations