<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/NCT01662869</url>
  </required_header>
  <id_info>
    <org_study_id>YO28322</org_study_id>
    <secondary_id>2012-001402-23</secondary_id>
    <nct_id>NCT01662869</nct_id>
  </id_info>
  <brief_title>A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer</brief_title>
  <official_title>A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With 5-Fluorouracil, Folinic Acid, and Oxaliplatin (mFOLFOX6) in Patients With Metastatic HER2-Negative, MET-Positive Gastroesophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This randomized, multicenter, double-blind, placebo-controlled study will evaluate the&#xD;
      efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid,&#xD;
      and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor&#xD;
      (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction.&#xD;
      Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in&#xD;
      combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until&#xD;
      disease progression, unacceptable toxicity, participant or physician decision to discontinue&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup</measure>
    <time_frame>Baseline until death (up to approximately 38 months overall)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>OS in the Intent-To-Treat (ITT) Population</measure>
    <time_frame>Baseline until death (up to approximately 38 months overall)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response, as Assessed by Investigator Using RECIST v1.1</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Tumor Response of CR or PR or Stable Disease (SD, Maintained for At Least 6 Months) as Determined by the Investigator Using RECIST v1.1</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events</measure>
    <time_frame>Baseline up to approximately 38 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) of Onartuzumab</measure>
    <time_frame>Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1 and 4, (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in ATAs Level of Onartuzumab</measure>
    <time_frame>Baseline (pre-dose [within 1 hour before infusion start] on Cycle 1 Day 1), pre-dose on Cycle 4 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Serum Concentration of Onartuzumab (Cmin)</measure>
    <time_frame>Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1, 2 and 4, 30 minutes after end of infusion (duration of infusion = 60 minutes) on Cycle 1 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of Onartuzumab</measure>
    <time_frame>Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1, 2 and 4, 30 minutes after end of infusion (duration of infusion = 60 minutes) on Cycle 1 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in MET IHC 2+/3+ Participant Subgroup</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 38 months overall)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS, as Assessed by Investigator Using RECIST v1.1 in ITT Population</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Tumor Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator Using RECIST v1.1 in MET IHC 2+/3+ Participant Subgroup</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Tumor Response of CR or PR as Determined by the Investigator Using RECIST v1.1 in ITT Population</measure>
    <time_frame>Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organization for Research and Treatment Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (EORTC QLQ-C30) Score</measure>
    <time_frame>Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-Gastric cancer Specific Quality of Life Questionnaire (EORTC QLQ-STOC22) Score</measure>
    <time_frame>Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Score</measure>
    <time_frame>Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">564</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Onartuzumab+mFOLFOX6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive onartuzumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion + mFOLFOX6 (oxaliplatin, folinic acid, and 5-fluoruracil) regimen. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with onartuzumab. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with onartuzumab will continue treatment with onartuzumab until disease progression, unacceptable toxicity, or death.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo+mFOLFOX6</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive onartuzumab matching placebo + mFOLFOX6. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with placebo. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with placebo will continue treatment with placebo until disease progression, unacceptable toxicity, or death.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-Fluoruracil</intervention_name>
    <description>Participants will receive 5-fluorouracil 400 milligrams per square meter (mg/m^2) IV bolus and then 2400 mg/m^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.</description>
    <arm_group_label>Onartuzumab+mFOLFOX6</arm_group_label>
    <arm_group_label>Placebo+mFOLFOX6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folinic acid</intervention_name>
    <description>Participants will receive folinic acid 400 mg/m^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.</description>
    <arm_group_label>Onartuzumab+mFOLFOX6</arm_group_label>
    <arm_group_label>Placebo+mFOLFOX6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Onartuzumab</intervention_name>
    <description>Participants will receive onartuzumab 10 mg/kg IV infusion on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.</description>
    <arm_group_label>Onartuzumab+mFOLFOX6</arm_group_label>
    <other_name>MetMAb, RO5490258, PRO143966</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Participants will receive oxaliplatin 85 mg/m^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.</description>
    <arm_group_label>Onartuzumab+mFOLFOX6</arm_group_label>
    <arm_group_label>Placebo+mFOLFOX6</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive onartuzumab matching placebo on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.</description>
    <arm_group_label>Placebo+mFOLFOX6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic&#xD;
             disease, not amenable to curative therapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1&#xD;
&#xD;
          -  Life expectancy greater than (&gt;) 3 months&#xD;
&#xD;
          -  Presence of tissue sample for IHC assay of MET receptor and HER2 status&#xD;
&#xD;
          -  Tumor (primary or metastatic lesion) defined as MET-positive by IHC&#xD;
&#xD;
          -  Measurable disease or non-measurable but evaluable disease, according to the RECIST&#xD;
             v1.1; Participants with peritoneal disease would generally be regarded as having&#xD;
             evaluable disease and allowed to enter the trial&#xD;
&#xD;
          -  For women who are not postmenopausal or surgically sterile; agreement to use an&#xD;
             adequate method of contraception (hormonal implant) during the treatment period and&#xD;
             for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the&#xD;
             last dose of oxaliplatin&#xD;
&#xD;
          -  For men: agreement to use a barrier method of contraception during the treatment&#xD;
             period and for 90 days after the last dose of onartuzumab/placebo and 6 months after&#xD;
             the last dose of oxaliplatin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HER2-positive tumor (primary tumor or metastasis)&#xD;
&#xD;
          -  Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant&#xD;
             or neoadjuvant chemotherapy must be completed at least 6 months prior to&#xD;
             randomization)&#xD;
&#xD;
          -  Prior treatment with investigational drugs that target the human growth factor (HGF)&#xD;
             or MET pathway&#xD;
&#xD;
          -  History of another malignancy within the previous 5 years, except for appropriately&#xD;
             treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin&#xD;
             carcinoma, Stage 1 uterine cancer, and localized prostate cancer&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Receipt of an investigational drug within 28 days prior to study start&#xD;
&#xD;
          -  Clinically significant gastrointestinal abnormalities, apart from gastric cancer,&#xD;
             including uncontrolled inflammatory gastrointestinal diseases&#xD;
&#xD;
          -  Significant history of cardiac disease&#xD;
&#xD;
          -  Significant vascular disease&#xD;
&#xD;
          -  Serious active infection at the time of randomization, or other serious underlying&#xD;
             medical conditions that would impair the ability of the participant to receive&#xD;
             protocol treatment&#xD;
&#xD;
          -  Infection with human immunodeficiency virus, hepatitis B, or hepatitis C&#xD;
&#xD;
          -  Radiotherapy within 4 weeks before start of study treatment&#xD;
&#xD;
          -  Major surgery within 4 weeks before start of study treatment, without complete&#xD;
             recovery&#xD;
&#xD;
          -  Any condition (psychological, geographical) that does not permit compliance with study&#xD;
             and follow-up procedures&#xD;
&#xD;
          -  Peripheral neuropathy&#xD;
&#xD;
          -  Prior unanticipated severe reaction to fluoropyrimidine therapy&#xD;
&#xD;
          -  Known sensitivity or contraindication to any component of study treatment&#xD;
&#xD;
          -  Active gastrointestinal bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Port Macquarie</city>
        <state>New South Wales</state>
        <zip>2444</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>East Bentleigh</city>
        <state>Victoria</state>
        <zip>VIC 3165</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1N9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brno</city>
        <zip>656 53</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olomouc</city>
        <zip>775 20</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Angers</city>
        <zip>49055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Avignon</city>
        <zip>84918</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Besancon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clichy</city>
        <zip>92118</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bochum</city>
        <zip>44892</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <zip>22767</zip>
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    <facility>
      <address>
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    <facility>
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    <facility>
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    <facility>
      <address>
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        <zip>81675</zip>
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    <facility>
      <address>
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        <zip>01010</zip>
        <country>Guatemala</country>
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    <facility>
      <address>
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        <zip>852</zip>
        <country>Hong Kong</country>
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    <facility>
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    <facility>
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    <facility>
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    <facility>
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    <facility>
      <address>
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    <facility>
      <address>
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    <facility>
      <address>
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        <zip>135-720</zip>
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    <facility>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
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    <facility>
      <address>
        <city>Sabah</city>
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      <address>
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    <facility>
      <address>
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        <zip>64020</zip>
        <country>Mexico</country>
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    <facility>
      <address>
        <city>Oaxaca</city>
        <zip>68000</zip>
        <country>Mexico</country>
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    <facility>
      <address>
        <city>Panama</city>
        <zip>0834-02723</zip>
        <country>Panama</country>
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    <facility>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
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    <facility>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
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    <facility>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
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  </location>
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    <facility>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
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  </location>
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    <facility>
      <address>
        <city>Rybnik</city>
        <zip>44-200</zip>
        <country>Poland</country>
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    <facility>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
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    <facility>
      <address>
        <city>Ivanovo</city>
        <zip>153040</zip>
        <country>Russian Federation</country>
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    <facility>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
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    <facility>
      <address>
        <city>Ryazan</city>
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        <country>Russian Federation</country>
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    <facility>
      <address>
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    <facility>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
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    <facility>
      <address>
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        <country>Singapore</country>
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    <facility>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
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    <facility>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
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    <facility>
      <address>
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      <address>
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        <country>Spain</country>
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    <facility>
      <address>
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        <country>Spain</country>
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    <facility>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
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    </facility>
  </location>
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    <facility>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
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    </facility>
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    <facility>
      <address>
        <city>Luzern</city>
        <zip>6004</zip>
        <country>Switzerland</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Zürich</city>
        <zip>8063</zip>
        <country>Switzerland</country>
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    <facility>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
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    <facility>
      <address>
        <city>Kaohisung</city>
        <country>Taiwan</country>
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    <facility>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
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    <facility>
      <address>
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        <zip>407</zip>
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    <facility>
      <address>
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    <facility>
      <address>
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    <facility>
      <address>
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        <zip>112</zip>
        <country>Taiwan</country>
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    <facility>
      <address>
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    <facility>
      <address>
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    <facility>
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      <address>
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        <zip>57000</zip>
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    <facility>
      <address>
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        <country>Thailand</country>
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      <address>
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    <facility>
      <address>
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        <zip>07070</zip>
        <country>Turkey</country>
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    <facility>
      <address>
        <city>Edirne</city>
        <zip>22770</zip>
        <country>Turkey</country>
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    <facility>
      <address>
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        <zip>25240</zip>
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      <address>
        <city>Malatya</city>
        <zip>44280</zip>
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        <zip>55139</zip>
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    <facility>
      <address>
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    <facility>
      <address>
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  </location>
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    <facility>
      <address>
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        <zip>SM2 5PT</zip>
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      </address>
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  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czech Republic</country>
    <country>France</country>
    <country>Germany</country>
    <country>Guatemala</country>
    <country>Hong Kong</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Panama</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>China</country>
    <country>Ukraine</country>
  </removed_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Levoleucovorin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01662869
org study id: YO28322
secondary id: 2012-001402-23
nct id: NCT01662869
lead sponsor: 
collaborator: 
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the
      efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid,
      and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor
      (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction.
      Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in
      combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until
      disease progression, unacceptable toxicity, participant or physician decision to discontinue
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Overall survival (OS) in the MET Immunohistochemistry (IHC) 2+/3+ Participant Subgroup
time frame: Baseline until death (up to approximately 38 months overall)
measure: OS in the Intent-To-Treat (ITT) Population
time frame: Baseline until death (up to approximately 38 months overall)
measure: Duration of Response, as Assessed by Investigator Using RECIST v1.1
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
measure: Percentage of Participants with a Tumor Response of CR or PR or Stable Disease (SD, Maintained for At Least 6 Months) as Determined by the Investigator Using RECIST v1.1
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
measure: Percentage of Participants with Adverse Events
time frame: Baseline up to approximately 38 months
measure: Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) of Onartuzumab
time frame: Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1 and 4, (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)
measure: Change from Baseline in ATAs Level of Onartuzumab
time frame: Baseline (pre-dose [within 1 hour before infusion start] on Cycle 1 Day 1), pre-dose on Cycle 4 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)
measure: Minimum Serum Concentration of Onartuzumab (Cmin)
time frame: Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1, 2 and 4, 30 minutes after end of infusion (duration of infusion = 60 minutes) on Cycle 1 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)
measure: Maximum Serum Concentration (Cmax) of Onartuzumab
time frame: Pre-dose (within 1 hour before infusion start) on Day 1 of Cycles 1, 2 and 4, 30 minutes after end of infusion (duration of infusion = 60 minutes) on Cycle 1 Day 1 (cycle length = 14 days), at study drug discontinuation visit (up to 38 months)
measure: Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in MET IHC 2+/3+ Participant Subgroup
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 38 months overall)
measure: PFS, as Assessed by Investigator Using RECIST v1.1 in ITT Population
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
measure: Percentage of Participants with a Tumor Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator Using RECIST v1.1 in MET IHC 2+/3+ Participant Subgroup
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
measure: Percentage of Participants with a Tumor Response of CR or PR as Determined by the Investigator Using RECIST v1.1 in ITT Population
time frame: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 6 weeks for 12 months and thereafter every 12 weeks up to approximately 38 months overall)
measure: European Organization for Research and Treatment Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (EORTC QLQ-C30) Score
time frame: Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months
measure: EORTC QLQ-Gastric cancer Specific Quality of Life Questionnaire (EORTC QLQ-STOC22) Score
time frame: Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months
measure: European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Score
time frame: Day 1 of each treatment cycle (cycle length = 14 days) up to approximately 38 months
arm group label: Onartuzumab+mFOLFOX6
arm group type: Experimental
description: Participants will receive onartuzumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion + mFOLFOX6 (oxaliplatin, folinic acid, and 5-fluoruracil) regimen. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with onartuzumab. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with onartuzumab will continue treatment with onartuzumab until disease progression, unacceptable toxicity, or death.
arm group label: Placebo+mFOLFOX6
arm group type: Placebo Comparator
description: Participants will receive onartuzumab matching placebo + mFOLFOX6. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with placebo. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with placebo will continue treatment with placebo until disease progression, unacceptable toxicity, or death.
intervention type: Drug
intervention name: 5-Fluoruracil
description: Participants will receive 5-fluorouracil 400 milligrams per square meter (mg/m^2) IV bolus and then 2400 mg/m^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
arm group label: Onartuzumab+mFOLFOX6
arm group label: Placebo+mFOLFOX6
intervention type: Drug
intervention name: Folinic acid
description: Participants will receive folinic acid 400 mg/m^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
arm group label: Onartuzumab+mFOLFOX6
arm group label: Placebo+mFOLFOX6
intervention type: Drug
intervention name: Onartuzumab
description: Participants will receive onartuzumab 10 mg/kg IV infusion on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.
arm group label: Onartuzumab+mFOLFOX6
other name: MetMAb, RO5490258, PRO143966
intervention type: Drug
intervention name: Oxaliplatin
description: Participants will receive oxaliplatin 85 mg/m^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
arm group label: Onartuzumab+mFOLFOX6
arm group label: Placebo+mFOLFOX6
intervention type: Drug
intervention name: Placebo
description: Participants will receive onartuzumab matching placebo on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.
arm group label: Placebo+mFOLFOX6
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Australia
country: Belgium
country: Canada
country: Czech Republic
country: France
country: Germany
country: Guatemala
country: Hong Kong
country: Israel
country: Italy
country: Korea, Republic of
country: Malaysia
country: Mexico
country: Panama
country: Poland
country: Russian Federation
country: Singapore
country: Spain
country: Switzerland
country: Taiwan
country: Thailand
country: Turkey
country: United Kingdom
country: United States
country: Brazil
country: China
country: Ukraine
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Leucovorin
mesh term: Folic Acid
mesh term: Oxaliplatin
mesh term: Fluorouracil
mesh term: Levoleucovorin