A Phase 3 Study of Rilotumumab (AMG 102) With Cisplatin and Capecitabine (CX) as First-line Therapy in Gastric Cancer

Phase 3TerminatedNCT02137343

Amgen34 enrolled

Overview

This is a Phase 3, multicenter, randomized, double-blind, placebo controlled study of Rilotumumab (AMG 102) with Cisplatin and Capecitabine (CX) for untreated advanced mesenchymal epithelial transition factor (MET)-positive gastric or gastroesophageal junction adenocarcinoma (GEJ).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gastric Cancer

Interventions

RilotumumabDRUG

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/SF/MET-driven activities in cells.

PlaceboDRUG

Placebo

CisplatinDRUG

A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 Years

Medical Language ↔ Plain English

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). * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. * Male or female subject greater than or equal to 20 years of age at the time of informed consent. 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 or lower esophageal adenocarcinoma. * Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization. * Squamous cell histology.

Locations (25)

Research Site

Nagoya, Aichi-ken, Japan

Research Site

Chiba, Chiba, Japan

Outcomes

Primary Outcomes

Progression-free survival

To determine if the treatment of rilotumumab in combination with CX significantly improves progression-free survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression.

Time frame: 4 years

Overall Survival

To determine if the treatment of rilotumumab in combination with CX significantly improves overall survival as compared with rilotumumab-placebo in combination with CX in subjects with unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma with MET-positive expression.

Time frame: 4 years

Secondary Outcomes

TTP

Time to Progression (TTP)

Time frame: 4 years

ORR

Objective Response Rate

Time frame: 4 years

DCR

Disease Control Rate

Time frame: 4 years

TTR

Time to Response

Time frame: 4 years

Incidence of subject adverse events, laboratory abnormalities and immunogenicity

Adverse events and laboratory abnormalities are reported by Common Terminology Criteria for Adverse Events (CTCAE) (v3.0)

Time frame: 4 years

Data from ClinicalTrials.gov

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