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.)
Information provided by (Responsible Party):
Amgen Identifier:
First received: September 26, 2012
Last updated: August 11, 2015
Last verified: August 2015

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
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: 610
Study Start Date: October 2012
Estimated Study Completion Date: September 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
Placebo Comparator: Placebo
Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
Other: Placebo
Other Name: sterile protein-free solution


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01697072

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Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amgen Identifier: NCT01697072     History of Changes
Other Study ID Numbers: 20070622, 2011-004923-11
Study First Received: September 26, 2012
Last Updated: August 11, 2015
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:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on October 06, 2015