Gastric Cancer
Conditions
Keywords
Gastric Cancer, First Line Treatment Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer (GEJ), GEJ Cancer
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
Interventions
DRUGRilotumumab
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.
OTHERPlacebo
Placebo
DRUGEpirubicin
Epirubicin is an anthracycline cytotoxic agent.
DRUGCisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
DRUGCapecitabine
Capecitabine is an oral fluoropyrimidine.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TTP | 3 years | Time to Progression (TTP) |
| ORR | 3 years | Objective Response Rate (ORR) |
| DCR | 3 years | Disease Control Rate (DCR) |
| PFS | 3 years | Progression Free Survival (PFS) |
| Safety | 3 years | — |
| Immunogenicity | 3 years | — |
| TTR | 3 years | Time to Response (TTR) |
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Mexico, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Outcome results
None listed