First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Rilotumumab
* Other: Placebo
* Drug: Epirubicin
* Drug: Cisplatin
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rilotumumab<br>Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX) | Drug: Rilotumumab<br>* 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.<br>* Other names: AMG102;Drug: Epirubicin<br>* Epirubicin is an anthracycline cytotoxic agent.<br>* Other names: Pharmorubicin RDF;Drug: Cisplatin<br>* Cisplatin is a non-cell cycle specific chemotherapeutic agent.<br>* Other names: Platinol-AQ;Drug: Capecitabine<br>* Capecitabine is an oral fluoropyrimidine.<br>* Other names: Xeloda;|
| Placebo Comparator: Placebo<br>Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX) | Other: Placebo<br>* Placebo<br>* Other names: sterile protein-free solution;Drug: Epirubicin<br>* Epirubicin is an anthracycline cytotoxic agent.<br>* Other names: Pharmorubicin RDF;Drug: Cisplatin<br>* Cisplatin is a non-cell cycle specific chemotherapeutic agent.<br>* Other names: Platinol-AQ;Drug: Capecitabine<br>* Capecitabine is an oral fluoropyrimidine.<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival (PFS) | 3 years | 
| TTP | Time to Progression (TTP) | 3 years | 
| ORR | Objective Response Rate (ORR) | 3 years | 
| DCR | Disease Control Rate (DCR) | 3 years | 
| TTR | Time to Response (TTR) | 3 years | 
| Safety |  | 3 years | 
| Immunogenicity |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Cancer, First Line Treatment Gastroesophageal Junction (GEJ), Gastroesophageal Junction Cancer (GEJ), GEJ Cancer