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

Phase 3

Terminated

• Conditions: Gastric Cancer
• Interventions: Other: Placebo; Drug: Rilotumumab; Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine

• Registration Number: NCT01697072
• Lead Sponsor: Amgen

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-09-28
• Study Start: 2012-10
• Study First Posted: 2012-10-02
• Primary Completion: 2014-11
• Study Completion: 2015-08
• Disposition First Submitted: 2015-10-22
• Disposition First Submitted QC: 2015-10-22
• Disposition First Posted: 2015-11-13
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 609

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%

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Rilotumumab	Epirubicin	Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Rilotumumab	Cisplatin	Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Rilotumumab	Capecitabine	Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Placebo	Epirubicin	Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Placebo	Cisplatin	Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Placebo	Capecitabine	Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Rilotumumab	Rilotumumab	Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety	3 years
Immunogenicity	3 years
TTR	3 years	Time to Response (TTR)
DCR	3 years	Disease Control Rate (DCR)
PFS	3 years	Progression Free Survival (PFS)
TTP	3 years	Time to Progression (TTP)
ORR	3 years	Objective Response Rate (ORR)

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, United Kingdom