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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)

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ClinicalTrials.gov Identifier: NCT01697072
Recruitment Status : Terminated (All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data Monitoring Committee safety review of study 20070622.)
First Posted : October 2, 2012
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Rilotumumab Other: Placebo Drug: Epirubicin Drug: Cisplatin Drug: Capecitabine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 609 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : August 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 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 :
  1. PFS [ Time Frame: 3 years ]
    Progression Free Survival (PFS)

  2. TTP [ Time Frame: 3 years ]
    Time to Progression (TTP)

  3. ORR [ Time Frame: 3 years ]
    Objective Response Rate (ORR)

  4. DCR [ Time Frame: 3 years ]
    Disease Control Rate (DCR)

  5. TTR [ Time Frame: 3 years ]
    Time to Response (TTR)

  6. Safety [ Time Frame: 3 years ]
  7. Immunogenicity [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697072


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01697072    
Other Study ID Numbers: 20070622
2011-004923-11 ( EudraCT Number )
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: January 2016
Keywords provided by Amgen:
Gastric Cancer
First Line Treatment Gastroesophageal Junction (GEJ)
Gastroesophageal Junction Cancer (GEJ)
GEJ Cancer
Additional relevant MeSH terms:
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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
Rilotumumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological