<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/NCT03755791</url>
  </required_header>
  <id_info>
    <org_study_id>XL184-312</org_study_id>
    <nct_id>NCT03755791</nct_id>
  </id_info>
  <brief_title>Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy</brief_title>
  <acronym>COSMIC-312</acronym>
  <official_title>A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exelixis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Exelixis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with&#xD;
      atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular&#xD;
      carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent&#xD;
      cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in&#xD;
      order to determine its contribution to the overall safety and efficacy of the combination&#xD;
      with atezolizumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, open-label, controlled Phase 3 trial of cabozantinib in&#xD;
      combination with atezolizumab versus sorafenib in adults with advanced HCC who have not&#xD;
      received previous systemic anticancer therapy in the advanced HCC setting. The primary&#xD;
      objective of this study is to evaluate the effect of cabozantinib in combination with&#xD;
      atezolizumab on the duration of progression-free survival (PFS) and duration of overall&#xD;
      survival (OS) versus sorafenib. The secondary objective is to evaluate the activity of&#xD;
      single-agent cabozantinib compared with sorafenib in this patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 10, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Actual">March 8, 2021</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>
    <intervention_model_description>Approximately 740 eligible subjects with advanced HCC will be randomized in a 2:1:1 ratio. Experimental arm (approximately 370 subjects) will receive cabozantinib plus atezolizumab. Control arm (approximately 185 subjects) will receive sorafenib. Single-agent cabozantinib arm (approximately 185 subjects) will receive single-agent cabozantinib</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Progression Free Survival (PFS) for the experimental arm vs. the control arm</measure>
    <time_frame>Up to 25 months after the first subject is randomized. Defined as time from randomization to the earlier of progressive disease (PD) per RECIST 1.1 as determined by the Blinded Independent Radiology Committee (BIRC) or death from any cause.</time_frame>
    <description>Duration of PFS per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Overall Survival (OS) for the experimental arm vs. the control arm</measure>
    <time_frame>Up to 38 months after the first subject is randomized. Defined as time from randomization to date of death from any cause.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Progression Free Survival (PFS) for the single-agent arm vs. the control arm</measure>
    <time_frame>Up to 20 months after the first subject is randomized.</time_frame>
    <description>Duration of PFS per RECIST 1.1 by BIRC</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">837</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with advanced HCC will receive cabozantinib 40 mg oral, qd + atezolizumab 1200 mg infusion, q3w</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects with advanced HCC will receive sorafenib 400 mg bid (twice a day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single-Agent Cabozantinib arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects with advanced HCC will receive cabozantinib 60 mg qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabozantinib</intervention_name>
    <description>Supplied as 20-mg tablets; administered orally daily at 40 mg</description>
    <arm_group_label>Experimental arm</arm_group_label>
    <other_name>XL184</other_name>
    <other_name>Cabometyx®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabozantinib</intervention_name>
    <description>Supplied as 60-mg tablets; administered orally once daily at 60 mg</description>
    <arm_group_label>Single-Agent Cabozantinib arm</arm_group_label>
    <other_name>XL184</other_name>
    <other_name>Cabometyx®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sorafenib</intervention_name>
    <description>Supplied as 200-mg tablets; administered orally twice daily at 400 mg</description>
    <arm_group_label>Control arm</arm_group_label>
    <other_name>Nexavar®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).</description>
    <arm_group_label>Experimental arm</arm_group_label>
    <other_name>Tecentriq®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic&#xD;
             patients by CT or MRI per the AASLD 2018 or EASL 2018 guidelines.&#xD;
&#xD;
          -  The subject has disease that is not amenable to a curative treatment approach (eg,&#xD;
             transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).&#xD;
&#xD;
          -  Measurable disease per RECIST 1.1 as determined by the Investigator.&#xD;
&#xD;
          -  Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.&#xD;
&#xD;
          -  Child-Pugh Score of A.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular&#xD;
             cholangiocarcinoma.&#xD;
&#xD;
          -  Prior systemic anticancer therapy for advanced HCC including but not limited to&#xD;
             chemotherapy, small molecule kinase inhibitors, and immune checkpoint inhibitors&#xD;
             (ICIs). Subjects who have received local intratumoral or arterial chemotherapy are&#xD;
             eligible; local anticancer therapy must be completed ≥ 28 days before randomization&#xD;
&#xD;
          -  Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy&#xD;
             within 8 weeks prior to randomization.&#xD;
&#xD;
          -  Known brain metastases or cranial epidural disease unless adequately treated with&#xD;
             radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks&#xD;
             prior to randomization.&#xD;
&#xD;
          -  Concomitant anticoagulation with oral anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Exelixis Clinical Site #208</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #159</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #44</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #112</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #200</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868-3201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #2</name>
      <address>
        <city>Rialto</city>
        <state>California</state>
        <zip>92377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #207</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #109</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #54</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #58</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #191</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #4</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #195</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #120</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #6</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #7</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #11</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #5</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #8</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #1</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #14</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #76</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #12</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7600</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #39</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #176</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #88</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #144</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #199</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #154</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #19</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #13</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #46</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #3</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #217</name>
      <address>
        <city>City of Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #213</name>
      <address>
        <city>City of Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1199ABB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #216</name>
      <address>
        <city>City of Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1264AAA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #219</name>
      <address>
        <city>Pilar</city>
        <state>Buenos Aires</state>
        <zip>B1629ODT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #220</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #201</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000CVB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #78</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #165</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #171</name>
      <address>
        <city>Kingswood</city>
        <state>New South Wales</state>
        <zip>2747</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #126</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #155</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #142</name>
      <address>
        <city>Greenslopes</city>
        <state>Queensland</state>
        <zip>4120</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #17</name>
      <address>
        <city>Kurralta Park</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #107</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #166</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #72</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #190</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #150</name>
      <address>
        <city>Klagenfurt</city>
        <state>Kärnten</state>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #137</name>
      <address>
        <city>St. Pölten</city>
        <state>Lower Austria</state>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #64</name>
      <address>
        <city>Linz</city>
        <state>Oberosterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #198</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #174</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #50</name>
      <address>
        <city>Brussels</city>
        <state>California</state>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #65</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #169</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #148</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #57</name>
      <address>
        <city>Haine-Saint-Paul</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #188</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #102</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #184</name>
      <address>
        <city>Salvador</city>
        <state>BA</state>
        <zip>40110-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #89</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30110-022</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #98</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30130-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #113</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #203</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90050-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #175</name>
      <address>
        <city>Barretos</city>
        <state>SP</state>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #121</name>
      <address>
        <city>Jaú</city>
        <state>SP</state>
        <zip>17210-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #186</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01246-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #156</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01321-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #187</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01509-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #181</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04538-132</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #91</name>
      <address>
        <city>São Paulo</city>
        <zip>04543-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #71</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #205</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #34</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #222</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #194</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #212</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #85</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #233</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230036</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #228</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #225</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #242</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510280</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #227</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #230</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #231</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #224</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #241</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #185</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #221</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #238</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #234</name>
      <address>
        <city>Jiangyin</city>
        <state>Jiansu</state>
        <zip>214400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #246</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #229</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #236</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #226</name>
      <address>
        <city>Linyi</city>
        <state>Shandong</state>
        <zip>276000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #235</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #218</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #223</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #239</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #237</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #240</name>
      <address>
        <city>Shanghai</city>
        <zip>200001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #232</name>
      <address>
        <city>Shanghai</city>
        <zip>201305</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #130</name>
      <address>
        <city>Montería</city>
        <state>Cordoba</state>
        <zip>230002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #18</name>
      <address>
        <city>Hradec Králové</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #37</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #10</name>
      <address>
        <city>Praha 4</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #38</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #43</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #27</name>
      <address>
        <city>Besancon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #56</name>
      <address>
        <city>Bondy Cedex</city>
        <zip>93140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #29</name>
      <address>
        <city>Caen Cedex 09</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #48</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #23</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #55</name>
      <address>
        <city>Lille Cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #16</name>
      <address>
        <city>Lyon Cedex 4</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #31</name>
      <address>
        <city>Montbeliard</city>
        <zip>25250</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #49</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #47</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #51</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #20</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #32</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #69</name>
      <address>
        <city>Batumi</city>
        <zip>6000</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #66</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #68</name>
      <address>
        <city>Tbilisi</city>
        <zip>0114</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #67</name>
      <address>
        <city>Tbilisi</city>
        <zip>0144</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #70</name>
      <address>
        <city>Tbilisi</city>
        <zip>0186</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #244</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #210</name>
      <address>
        <city>Kassel</city>
        <state>Hessen</state>
        <zip>34125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #214</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #215</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #146</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #42</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #9</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #140</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #25</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #26</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #170</name>
      <address>
        <city>Dublin</city>
        <zip>8</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #30</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #33</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #40</name>
      <address>
        <city>Ramat-Gan</city>
        <zip>5262101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #35</name>
      <address>
        <city>Rehovot</city>
        <zip>7661041</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #163</name>
      <address>
        <city>Tricase</city>
        <state>Lecce</state>
        <zip>73039</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #53</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #158</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #152</name>
      <address>
        <city>Brescia</city>
        <zip>25124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #147</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #149</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #131</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #167</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #177</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #182</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #243</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #157</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #127</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #77</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #86</name>
      <address>
        <city>Busan</city>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #114</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #75</name>
      <address>
        <city>Incheon</city>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #104</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #105</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #99</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #79</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #93</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #141</name>
      <address>
        <city>Tuxtla Gutiérrez</city>
        <state>Chiapas</state>
        <zip>29038</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #135</name>
      <address>
        <city>León</city>
        <state>Guanajuato</state>
        <zip>37000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #132</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #133</name>
      <address>
        <city>Ciudad De México</city>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #160</name>
      <address>
        <city>Mexico City</city>
        <zip>06760</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #134</name>
      <address>
        <city>San Luis Potosí</city>
        <zip>78250</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #153</name>
      <address>
        <city>Veracruz</city>
        <zip>94300</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #92</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #52</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #84</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #36</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #60</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #62</name>
      <address>
        <city>Newton</city>
        <state>Wellington</state>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #118</name>
      <address>
        <city>Cebu City</city>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #117</name>
      <address>
        <city>Pasig City</city>
        <zip>1605</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #136</name>
      <address>
        <city>Quezon City</city>
        <zip>1102</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #41</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #24</name>
      <address>
        <city>Gdansk</city>
        <state>Pomorskie</state>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #15</name>
      <address>
        <city>Mysłowice</city>
        <state>Slaskie</state>
        <zip>41-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #204</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #211</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #202</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400641</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #206</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #209</name>
      <address>
        <city>Iaşi</city>
        <zip>700483</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #74</name>
      <address>
        <city>Kislino</city>
        <state>Kursk Region</state>
        <zip>305524</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #81</name>
      <address>
        <city>Kaluga</city>
        <zip>248007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #95</name>
      <address>
        <city>Krasnodar</city>
        <zip>350040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #108</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #101</name>
      <address>
        <city>Murmansk</city>
        <zip>183047</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #80</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603137</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #111</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #90</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #73</name>
      <address>
        <city>Sochi</city>
        <zip>354057</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #106</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #97</name>
      <address>
        <city>Singapore</city>
        <zip>217562</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #116</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #28</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #21</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #22</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #59</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #103</name>
      <address>
        <city>Barcelona</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #164</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #63</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #168</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #45</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #115</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #172</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #110</name>
      <address>
        <city>Saint Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #61</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #119</name>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #162</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #161</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #197</name>
      <address>
        <city>Tainan City</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #145</name>
      <address>
        <city>Tainan</city>
        <zip>736</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #82</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #128</name>
      <address>
        <city>Taipei</city>
        <zip>10491</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixisi Clinical Site #100</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #94</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #96</name>
      <address>
        <city>Pathum Wan</city>
        <state>Bangkok</state>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #183</name>
      <address>
        <city>Muang</city>
        <state>Khon Kaen</state>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #139</name>
      <address>
        <city>Hat Yai</city>
        <state>Songkla</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #143</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #189</name>
      <address>
        <city>Istanbul</city>
        <state>Instanbul</state>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #193</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #178</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #173</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #179</name>
      <address>
        <city>Istanbul</city>
        <zip>34214</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #180</name>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #125</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58013</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #122</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #123</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #124</name>
      <address>
        <city>Odesa</city>
        <zip>65055</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #138</name>
      <address>
        <city>Uzhhorod</city>
        <zip>88000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #83</name>
      <address>
        <city>Bristol</city>
        <state>England</state>
        <zip>BS2 8ED</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #87</name>
      <address>
        <city>Cambridge</city>
        <state>England</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #151</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #129</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #192</name>
      <address>
        <city>Manchester</city>
        <state>England</state>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #196</name>
      <address>
        <city>Belfast</city>
        <state>Northern Ireland</state>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <disposition_first_submitted>March 8, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>March 14, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 16, 2022</disposition_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>liver</keyword>
  <keyword>cancer</keyword>
  <keyword>hepatocellular</keyword>
  <keyword>carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sorafenib</mesh_term>
    <mesh_term>Atezolizumab</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/NCT03755791
org study id: XL184-312
nct id: NCT03755791
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with
      atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular
      carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent
      cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in
      order to determine its contribution to the overall safety and efficacy of the combination
      with atezolizumab.
This is a multicenter, randomized, open-label, controlled Phase 3 trial of cabozantinib in
      combination with atezolizumab versus sorafenib in adults with advanced HCC who have not
      received previous systemic anticancer therapy in the advanced HCC setting. The primary
      objective of this study is to evaluate the effect of cabozantinib in combination with
      atezolizumab on the duration of progression-free survival (PFS) and duration of overall
      survival (OS) versus sorafenib. The secondary objective is to evaluate the activity of
      single-agent cabozantinib compared with sorafenib in this patient population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Approximately 740 eligible subjects with advanced HCC will be randomized in a 2:1:1 ratio. Experimental arm (approximately 370 subjects) will receive cabozantinib plus atezolizumab. Control arm (approximately 185 subjects) will receive sorafenib. Single-agent cabozantinib arm (approximately 185 subjects) will receive single-agent cabozantinib
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of Progression Free Survival (PFS) for the experimental arm vs. the control arm
time frame: Up to 25 months after the first subject is randomized. Defined as time from randomization to the earlier of progressive disease (PD) per RECIST 1.1 as determined by the Blinded Independent Radiology Committee (BIRC) or death from any cause.
description: Duration of PFS per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)
measure: Duration of Overall Survival (OS) for the experimental arm vs. the control arm
time frame: Up to 38 months after the first subject is randomized. Defined as time from randomization to date of death from any cause.
measure: Duration of Progression Free Survival (PFS) for the single-agent arm vs. the control arm
time frame: Up to 20 months after the first subject is randomized.
description: Duration of PFS per RECIST 1.1 by BIRC
arm group label: Experimental arm
arm group type: Experimental
description: Subjects with advanced HCC will receive cabozantinib 40 mg oral, qd + atezolizumab 1200 mg infusion, q3w
arm group label: Control arm
arm group type: Active Comparator
description: Subjects with advanced HCC will receive sorafenib 400 mg bid (twice a day)
arm group label: Single-Agent Cabozantinib arm
arm group type: Other
description: Subjects with advanced HCC will receive cabozantinib 60 mg qd
intervention type: Drug
intervention name: Cabozantinib
description: Supplied as 20-mg tablets; administered orally daily at 40 mg
arm group label: Experimental arm
other name: XL184
other name: Cabometyx®
intervention type: Drug
intervention name: Cabozantinib
description: Supplied as 60-mg tablets; administered orally once daily at 60 mg
arm group label: Single-Agent Cabozantinib arm
other name: XL184
other name: Cabometyx®
intervention type: Drug
intervention name: Sorafenib
description: Supplied as 200-mg tablets; administered orally twice daily at 400 mg
arm group label: Control arm
other name: Nexavar®
intervention type: Drug
intervention name: Atezolizumab
description: Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
arm group label: Experimental arm
other name: Tecentriq®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Canada
country: China
country: Colombia
country: Czechia
country: France
country: Georgia
country: Germany
country: Hong Kong
country: Hungary
country: Ireland
country: Israel
country: Italy
country: Korea, Republic of
country: Mexico
country: Netherlands
country: New Zealand
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: Singapore
country: Spain
country: Switzerland
country: Taiwan
country: Thailand
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Sorafenib
mesh term: Atezolizumab