<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01697072</url>
  </required_header>
  <id_info>
    <org_study_id>20070622</org_study_id>
    <secondary_id>2011-004923-11</secondary_id>
    <nct_id>NCT01697072</nct_id>
  </id_info>
  <brief_title>First-Line Treatment for Locally Advanced or Metastatic Mesenchymal Epithelial Transition Factor (MET) - Positive Gastric, Lower Esophageal, or Gastroesophageal Junction (GEJ) Adenocarcinoma</brief_title>
  <acronym>RILOMET-1</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 3, multicenter, randomized, double-blind, placebo controlled study of&#xD;
      epirubicin, cisplatin &amp; capecitabine (ECX) with rilotumumab or placebo for untreated advanced&#xD;
      MET-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    All Amgen sponsored AMG102 clinical studies were terminated following a pre-planned Data&#xD;
    Monitoring Committee safety review of study 20070622.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>3 years</time_frame>
    <description>Progression Free Survival (PFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TTP</measure>
    <time_frame>3 years</time_frame>
    <description>Time to Progression (TTP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>3 years</time_frame>
    <description>Objective Response Rate (ORR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>3 years</time_frame>
    <description>Disease Control Rate (DCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TTR</measure>
    <time_frame>3 years</time_frame>
    <description>Time to Response (TTR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">609</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Rilotumumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rilotumumab</intervention_name>
    <description>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.</description>
    <arm_group_label>Rilotumumab</arm_group_label>
    <other_name>AMG102</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>sterile protein-free solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epirubicin</intervention_name>
    <description>Epirubicin is an anthracycline cytotoxic agent.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Rilotumumab</arm_group_label>
    <other_name>Ellence</other_name>
    <other_name>Pharmorubicin PFS</other_name>
    <other_name>Pharmorubicin RDF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin is a non-cell cycle specific chemotherapeutic agent.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Rilotumumab</arm_group_label>
    <other_name>Platinol</other_name>
    <other_name>Platinol-AQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Capecitabine is an oral fluoropyrimidine.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Rilotumumab</arm_group_label>
    <other_name>Xeloda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed unresectable locally advanced or metastatic gastric or GEJ&#xD;
             adenocarcinoma •Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1)&#xD;
&#xD;
          -  Tumor MET-positive by immunohistochemistry (IHC)&#xD;
&#xD;
          -  Evaluable (measurable or non-measurable) disease by Response Evaluation Criteria In&#xD;
             Solid Tumors (RECIST) 1.1 criteria&#xD;
&#xD;
        Key exclusion criteria:&#xD;
&#xD;
          -  Human Epidermal Growth Factor Receptor 2 (HER2) -overexpressing locally advanced or&#xD;
             metastatic gastric or GEJ adenocarcinoma •Previous systemic therapy for locally&#xD;
             advanced or metastatic gastric or GEJ adenocarcinoma&#xD;
&#xD;
          -  Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant&#xD;
             chemotherapy or chemoradiotherapy to randomization&#xD;
&#xD;
          -  Previous treatment with anthracyclines must not exceed total cumulative dose of&#xD;
             epirubicin of 400 mg/m2&#xD;
&#xD;
          -  Squamous cell histology&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt; 50%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
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      <name>Research Site</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81008</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
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  </location>
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        <state>Maryland</state>
        <zip>21231</zip>
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        <state>Cataluña</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>A Coruña</city>
        <state>Galicia</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Eskilstuna</city>
        <zip>631 88</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bellinzona</city>
        <zip>6500</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gaziantep</city>
        <zip>27100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34390</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49102</zip>
        <country>Ukraine</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kherson</city>
        <zip>73035</zip>
        <country>Ukraine</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lutsk</city>
        <zip>43018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lviv</city>
        <zip>79031</zip>
        <country>Ukraine</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mariupol</city>
        <zip>87500</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sumy</city>
        <zip>40022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Uzhgorod</city>
        <zip>88000</zip>
        <country>Ukraine</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
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      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
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    <facility>
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      <address>
        <city>Guildford</city>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>NW1 2PQ</zip>
        <country>United Kingdom</country>
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      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
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      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
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  </location>
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      <name>Research Site</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
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  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Northwood</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salisbury</city>
        <zip>SP2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czech Republic</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <disposition_first_submitted>October 22, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>October 22, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 13, 2015</disposition_first_posted>
  <last_update_submitted>January 18, 2016</last_update_submitted>
  <last_update_submitted_qc>January 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>First Line Treatment Gastroesophageal Junction (GEJ)</keyword>
  <keyword>Gastroesophageal Junction Cancer (GEJ)</keyword>
  <keyword>GEJ Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Epirubicin</mesh_term>
    <mesh_term>Rilotumumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01697072
org study id: 20070622
secondary id: 2011-004923-11
nct id: NCT01697072
lead sponsor: 
has dmc: Yes
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall Survival
time frame: 3 years
description: 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
measure: PFS
time frame: 3 years
description: Progression Free Survival (PFS)
measure: TTP
time frame: 3 years
description: Time to Progression (TTP)
measure: ORR
time frame: 3 years
description: Objective Response Rate (ORR)
measure: DCR
time frame: 3 years
description: Disease Control Rate (DCR)
measure: TTR
time frame: 3 years
description: Time to Response (TTR)
measure: Safety
time frame: 3 years
measure: Immunogenicity
time frame: 3 years
arm group label: Rilotumumab
arm group type: Experimental
description: Rilotumumab (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
arm group label: Placebo
arm group type: Placebo Comparator
description: Rilotumumab-placebo (15 mg/kg, IV every 21 days) plus Epirubicin, Cisplatin and Capecitabine (ECX)
intervention type: Drug
intervention name: Rilotumumab
description: 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.
arm group label: Rilotumumab
other name: AMG102
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
other name: sterile protein-free solution
intervention type: Drug
intervention name: Epirubicin
description: Epirubicin is an anthracycline cytotoxic agent.
arm group label: Placebo
arm group label: Rilotumumab
other name: Ellence
other name: Pharmorubicin PFS
other name: Pharmorubicin RDF
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin is a non-cell cycle specific chemotherapeutic agent.
arm group label: Placebo
arm group label: Rilotumumab
other name: Platinol
other name: Platinol-AQ
intervention type: Drug
intervention name: Capecitabine
description: Capecitabine is an oral fluoropyrimidine.
arm group label: Placebo
arm group label: Rilotumumab
other name: Xeloda
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Australia
country: Austria
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Czech Republic
country: Denmark
country: France
country: Germany
country: Greece
country: Hungary
country: Italy
country: Mexico
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Slovakia
country: South Africa
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Stomach Neoplasms
mesh term: Cisplatin
mesh term: Capecitabine
mesh term: Epirubicin
mesh term: Rilotumumab