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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

September 26, 2012
January 18, 2016
October 2012
November 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01697072 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma
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
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Gastric Cancer
  • 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
  • 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
  • Experimental: Rilotumumab
    Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
    Interventions:
    • Drug: Rilotumumab
    • Drug: Epirubicin
    • Drug: Cisplatin
    • Drug: Capecitabine
  • Placebo Comparator: Placebo
    Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
    Interventions:
    • Other: Placebo
    • Drug: Epirubicin
    • Drug: Cisplatin
    • Drug: Capecitabine
Doshi S, Gisleskog PO, Zhang Y, Zhu M, Oliner KS, Loh E, Perez Ruixo JJ. Rilotumumab exposure-response relationship in patients with advanced or metastatic gastric cancer. Clin Cancer Res. 2015 Jun 1;21(11):2453-61. doi: 10.1158/1078-0432.CCR-14-1661.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
609
August 2015
November 2014   (final data collection date for primary outcome measure)

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%
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Mexico,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom
 
NCT01697072
20070622, 2011-004923-11
Yes
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP