First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma (RILOMET-1)

This study has been terminated.
(All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01697072
First received: September 26, 2012
Last updated: January 18, 2016
Last verified: January 2016
  Purpose
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

Condition Intervention Phase
Gastric Cancer
Drug: Rilotumumab
Other: Placebo
Drug: Epirubicin
Drug: Cisplatin
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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:
  • PFS [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Progression Free Survival (PFS)

  • TTP [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Time to Progression (TTP)

  • ORR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Objective Response Rate (ORR)

  • DCR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Disease Control Rate (DCR)

  • TTR [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Time to Response (TTR)

  • Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Immunogenicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 609
Study Start Date: October 2012
Study Completion Date: August 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rilotumumab
Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Drug: Rilotumumab
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.
Other Name: AMG102
Drug: Epirubicin
Epirubicin is an anthracycline cytotoxic agent.
Other Names:
  • Ellence
  • Pharmorubicin PFS
  • Pharmorubicin RDF
Drug: Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Other Names:
  • Platinol
  • Platinol-AQ
Drug: Capecitabine
Capecitabine is an oral fluoropyrimidine.
Other Name: Xeloda
Placebo Comparator: Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Other: Placebo
Placebo
Other Name: sterile protein-free solution
Drug: Epirubicin
Epirubicin is an anthracycline cytotoxic agent.
Other Names:
  • Ellence
  • Pharmorubicin PFS
  • Pharmorubicin RDF
Drug: Cisplatin
Cisplatin is a non-cell cycle specific chemotherapeutic agent.
Other Names:
  • Platinol
  • Platinol-AQ
Drug: Capecitabine
Capecitabine is an oral fluoropyrimidine.
Other Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697072

  Show 191 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01697072     History of Changes
Other Study ID Numbers: 20070622  2011-004923-11 
Study First Received: September 26, 2012
Last Updated: January 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Gastric Cancer
First Line Treatment Gastroesophageal Junction (GEJ)
Gastroesophageal Junction Cancer (GEJ)
GEJ Cancer

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Capecitabine
Epirubicin
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2016