<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/NCT04446117</url>
  </required_header>
  <id_info>
    <org_study_id>XL184-315</org_study_id>
    <nct_id>NCT04446117</nct_id>
  </id_info>
  <brief_title>Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC</brief_title>
  <acronym>CONTACT-02</acronym>
  <official_title>A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exelixis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche-Genentech</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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 is a Phase 3, multi-center, randomized, open-label, controlled study designed to&#xD;
      evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab&#xD;
      versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant&#xD;
      prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for&#xD;
      their prostate cancer disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to evaluate the efficacy of cabozantinib (XL184) in&#xD;
      combination with atezolizumab versus a second NHT (abiraterone or enzalutamide) in subjects&#xD;
      with mCRPC who have previously been treated with one, and only one, NHT (e.g. abiraterone,&#xD;
      apalutamide, darolutamide, or enzalutamide) to treat metastatic castration-sensitive prostate&#xD;
      cancer (mCSPC), non-metastatic CRPC (M0 CRPC), or mCRPC, and who have measurable extrapelvic&#xD;
      disease. The multiple primary efficacy endpoints comparing the experimental arm and control&#xD;
      arm are Duration of Progression Free Survival (PFS) per RECIST 1.1 by Blinded Independent&#xD;
      Radiology Committee (BIRC) and Duration of Overall Survival (OS). The secondary efficacy&#xD;
      endpoint is Objective Response Rate (ORR) per RECIST 1.1 per BIRC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Actual">June 30, 2023</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 580 eligible subjects will be randomized in a 1:1 fashion to the experimental arm receiving cabozantinib and atezolizumab in combination (290) or to the control arm receiving a second NHT (290).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Progression Free Survival per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)</measure>
    <time_frame>Approximately 21 months after the first subject is randomized.</time_frame>
    <description>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>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Overall Survival (OS)</measure>
    <time_frame>Approximately 37 months after the first subject is randomized</time_frame>
    <description>Defined as time from randomization to date of death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Approximately 37 months after the first subject is randomized</time_frame>
    <description>ORR per RECIST 1.1 by BIRC</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">575</enrollment>
  <condition>Metastatic Prostate Cancer</condition>
  <condition>Prostate Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg 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 mCRPC will receive active comparator of EITHER abiraterone 1000mg oral, qd + prednisone 5 mg oral, bid; OR enzalutamide 160mg oral, qd as designated by the Investigator prior to randomization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabozantinib</intervention_name>
    <description>Supplied as 20-mg tablets; administered orally daily at 40mg</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>Atezolizumab</intervention_name>
    <description>Supplied as 1200 mg/20 mL 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>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone Acetate</intervention_name>
    <description>Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid</description>
    <arm_group_label>Control Arm</arm_group_label>
    <other_name>Abiraterone</other_name>
    <other_name>Zytiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>Supplied as 40 mg capsules; administered orally daily at 160mg</description>
    <arm_group_label>Control Arm</arm_group_label>
    <other_name>Xtandi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men with histologically or cytologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide,&#xD;
             darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or&#xD;
             mCSPC, M0 CRPC, or mCRPC&#xD;
&#xD;
          -  Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at&#xD;
             screening&#xD;
&#xD;
          -  Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment&#xD;
             defined by at least one of the following: measurable visceral disease (eg, adrenal,&#xD;
             kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic&#xD;
             adenopathy (ie, adenopathy above the aortic bifurcation)&#xD;
&#xD;
          -  Progressive disease at study entry as defined by specific criteria for prostate&#xD;
             specific antigen (PSA) progression OR soft tissue disease progression in the opinion&#xD;
             of the Investigator (Note: subjects with bone disease progression alone are not&#xD;
             eligible)&#xD;
&#xD;
          -  Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the&#xD;
             day of consent&#xD;
&#xD;
          -  ECOG performance status of 0 or 1&#xD;
&#xD;
          -  Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events&#xD;
             (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are&#xD;
             clinically nonsignificant and/or stable on supportive therapy in the opinion of the&#xD;
             Investigator&#xD;
&#xD;
          -  Adequate organ and marrow function based upon specific laboratory assessments obtained&#xD;
             within 21 days prior to randomization&#xD;
&#xD;
          -  Understanding and ability to comply with protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any prior nonhormonal therapy initiated for the treatment of mCRPC&#xD;
&#xD;
          -  Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide,&#xD;
             nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2&#xD;
             weeks before randomization&#xD;
&#xD;
          -  Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization&#xD;
             (subjects with clinically relevant ongoing complications from prior radiation therapy&#xD;
             are not eligible)&#xD;
&#xD;
          -  Known brain metastases or cranial epidural disease unless adequately treated and&#xD;
             clinically stable at least 4 weeks prior to randomization&#xD;
&#xD;
          -  Symptomatic or impending spinal cord compression or cauda equina syndrome&#xD;
&#xD;
          -  Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)&#xD;
&#xD;
          -  Administration of a live, attenuated vaccine within 30 days prior to randomization&#xD;
&#xD;
          -  Systematic treatment with, or any condition requiring, either corticosteroids (&gt;10 mg&#xD;
             daily prednisone equivalent) or other immunosuppressive medications within 14 days&#xD;
             prior to randomization&#xD;
&#xD;
          -  Uncontrolled, significant intercurrent or recent illness&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to randomization&#xD;
&#xD;
          -  Corrected QT interval calculated by the Fridericia formula (QTcF) &gt; 480 ms per ECG&#xD;
             within 21 days before randomization&#xD;
&#xD;
          -  Inability or unwillingness to swallow pills or receive IV administration&#xD;
&#xD;
          -  Previously identified allergy or hypersensitivity to components of the study treatment&#xD;
             formulations or history of severe infusion-related reactions to monoclonal antibodies&#xD;
&#xD;
          -  Any other active malignancy at time of randomization or diagnosis of another&#xD;
             malignancy within 2 years prior to randomization that requires active treatment (some&#xD;
             exceptions apply such as locally curable cancers that have apparently been cured).&#xD;
      </textblock>
    </criteria>
    <gender>Male</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 #4</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #42</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #2</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #224</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0698</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #114</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #125</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #245</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #91</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #14</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #108</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #215</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #242</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #6</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #203</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #19</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #144</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 #123</name>
      <address>
        <city>East Brunswick</city>
        <state>New Jersey</state>
        <zip>08816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #198</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #159</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #221</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #18</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #201</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #1</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #5</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #177</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #259</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #41</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #67</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #143</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #122</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <state>Buenos Aires</state>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #120</name>
      <address>
        <city>Mar Del Plata</city>
        <state>Buenos Aires</state>
        <zip>B7600FZO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #170</name>
      <address>
        <city>Pergamino</city>
        <state>Buenos Aires</state>
        <zip>B2700CPM</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #210</name>
      <address>
        <city>Córdoba</city>
        <state>Cordoba</state>
        <zip>X5004FHP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #152</name>
      <address>
        <city>Viedma</city>
        <state>Rio Negro</state>
        <zip>R8500ACE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #183</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000CVB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #261</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000KZE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #200</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1426ANZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #256</name>
      <address>
        <city>Caba</city>
        <zip>C1120AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #44</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <zip>C1012AAR</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #105</name>
      <address>
        <city>La Rioja</city>
        <zip>F5300</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #124</name>
      <address>
        <city>San Juan</city>
        <zip>5400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #101</name>
      <address>
        <city>San Salvador De Jujuy</city>
        <zip>Y4600EHA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #151</name>
      <address>
        <city>Garran</city>
        <state>Australian Capital Territory</state>
        <zip>2605</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #252</name>
      <address>
        <city>Port Macquarie</city>
        <state>New South Wales</state>
        <zip>2444</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #175</name>
      <address>
        <city>Saint Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site # 189</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #162</name>
      <address>
        <city>Wollongong</city>
        <state>New South Wales</state>
        <zip>2500</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #253</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #103</name>
      <address>
        <city>Launceston</city>
        <state>Tasmania</state>
        <zip>7250</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #79</name>
      <address>
        <city>Ballarat</city>
        <state>Victoria</state>
        <zip>3350</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #95</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #262</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #53</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Stie #260</name>
      <address>
        <city>Saint Albans</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #115</name>
      <address>
        <city>Adelaide</city>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #149</name>
      <address>
        <city>Box Hill</city>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #158</name>
      <address>
        <city>Linz</city>
        <state>Oberösterreich</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odensklinikum Linz GmbH Elisabethinen #156</name>
      <address>
        <city>Linz</city>
        <state>Oberösterreich</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #218</name>
      <address>
        <city>Wien</city>
        <zip>1080</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #126</name>
      <address>
        <city>Bonheiden</city>
        <state>Antwerpen</state>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #39</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #141</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #165</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #204</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>80520-174</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #163</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <zip>80510-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #157</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-00</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #171</name>
      <address>
        <city>Rio De Janeiro</city>
        <state>RJ</state>
        <zip>22793-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #132</name>
      <address>
        <city>Blumenau</city>
        <state>Santa Catarina</state>
        <zip>89010-340</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #191</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13083-970</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #161</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04538-132</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #128</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14048-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #106</name>
      <address>
        <city>São José Do Rio Preto</city>
        <state>São Paulo</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #154</name>
      <address>
        <city>Barretos</city>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #140</name>
      <address>
        <city>Fortaleza</city>
        <zip>60336-232</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #153</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90110-270</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #145</name>
      <address>
        <city>Ribeirão Preto</city>
        <zip>14015-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #116</name>
      <address>
        <city>Santa Cruz Do Sul</city>
        <zip>96810-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #69</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #112</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 5L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #147</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1C 6Z8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #83</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #127</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #7</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6H 3PI</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #178</name>
      <address>
        <city>Granby</city>
        <state>Quebec</state>
        <zip>J2GIT7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #160</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #247</name>
      <address>
        <city>Viña del Mar</city>
        <state>Región De Valparaíso</state>
        <zip>2520598</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #139</name>
      <address>
        <city>Santiago de Chile</city>
        <state>Región Metropolitana De Santiago</state>
        <zip>7500921</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #263</name>
      <address>
        <city>Santiago</city>
        <state>Región Metropolitana</state>
        <zip>7500787</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #142</name>
      <address>
        <city>Providencia</city>
        <zip>7500713</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #148</name>
      <address>
        <city>Recoleta</city>
        <zip>8420383</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #90</name>
      <address>
        <city>Santiago</city>
        <zip>7500653</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #113</name>
      <address>
        <city>Temuco</city>
        <zip>4810469</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #119</name>
      <address>
        <city>Valparaíso</city>
        <zip>2540333</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #63</name>
      <address>
        <city>Praha 2</city>
        <state>Praha</state>
        <zip>120 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #129</name>
      <address>
        <city>Brno</city>
        <zip>656 91</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #130</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #80</name>
      <address>
        <city>Praha 2</city>
        <zip>128 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #47</name>
      <address>
        <city>Praha 8</city>
        <zip>180 81</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #31</name>
      <address>
        <city>Praha</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #134</name>
      <address>
        <city>Brest</city>
        <zip>29229</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #77</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #155</name>
      <address>
        <city>Dijon cedex</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #74</name>
      <address>
        <city>Hyères</city>
        <zip>83400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #222</name>
      <address>
        <city>La Roche-sur-Yon Cedex 9</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #146</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #38</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #66</name>
      <address>
        <city>Quimper</city>
        <zip>29107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #214</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #135</name>
      <address>
        <city>Saint-Grégoire</city>
        <zip>35760</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #213</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #36</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #73</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #85</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #230</name>
      <address>
        <city>Vandoeuvre les nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #16</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #9</name>
      <address>
        <city>Tbilisi</city>
        <zip>0141</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #10</name>
      <address>
        <city>Tbilisi</city>
        <zip>0144</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #11</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #15</name>
      <address>
        <city>Tbilisi</city>
        <zip>0167</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #8</name>
      <address>
        <city>Tbilisi</city>
        <zip>0186</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #176</name>
      <address>
        <city>Nürtingen</city>
        <state>Baden-Wuerttemberg</state>
        <zip>72622</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #98</name>
      <address>
        <city>Gutersloh</city>
        <state>Nordrhein-Westfalen</state>
        <zip>33332</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #180</name>
      <address>
        <city>Duisburg</city>
        <state>North Rhine-Westphalia</state>
        <zip>47179</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #179</name>
      <address>
        <city>Münster</city>
        <state>North Rhine-Westphalia</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #185</name>
      <address>
        <city>Lübeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #227</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #239</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #273</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #136</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #238</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #93</name>
      <address>
        <city>Cholargós</city>
        <state>Attica</state>
        <zip>15562</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #202</name>
      <address>
        <city>Maroussi</city>
        <state>Attica</state>
        <zip>15123</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #92</name>
      <address>
        <city>Maroúsi</city>
        <state>Attica</state>
        <zip>15125</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #244</name>
      <address>
        <city>Nea Kifisia</city>
        <state>Attica</state>
        <zip>14564</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #99</name>
      <address>
        <city>Néo Fáliro</city>
        <state>Attica</state>
        <zip>18547</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #45</name>
      <address>
        <city>Heraklion</city>
        <state>Crete</state>
        <zip>71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #64</name>
      <address>
        <city>Thessaloníki</city>
        <state>Macedonia</state>
        <zip>54007</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #97</name>
      <address>
        <city>Larissa</city>
        <state>Thessaly</state>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #118</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #207</name>
      <address>
        <city>Budapest</city>
        <zip>1082</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #57</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #109</name>
      <address>
        <city>Budapest</city>
        <zip>1145</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #240</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis site #167</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #55</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #27</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #150</name>
      <address>
        <city>Petah tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #117</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #30</name>
      <address>
        <city>Safed</city>
        <zip>1311001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #35</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #168</name>
      <address>
        <city>Meldola</city>
        <state>FC</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #246</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Site #156</name>
      <address>
        <city>Sondrio</city>
        <state>SO</state>
        <zip>23100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #199</name>
      <address>
        <city>Trento</city>
        <state>Trentino</state>
        <zip>38122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #217</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #121</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #258</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #192</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #267</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #237</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #107</name>
      <address>
        <city>Perugia</city>
        <zip>06132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #269</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #62</name>
      <address>
        <city>Roma</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #234</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #96</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #232</name>
      <address>
        <city>Toyota-shi</city>
        <state>Aichi</state>
        <zip>471-8513</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #100</name>
      <address>
        <city>Akita-Shi</city>
        <state>Akita</state>
        <zip>010-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #104</name>
      <address>
        <city>Hirosaki</city>
        <state>Aomori</state>
        <zip>036-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #43</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #54</name>
      <address>
        <city>Sakura-shi</city>
        <state>Chiba</state>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #72</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #37</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #70</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #52</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #84</name>
      <address>
        <city>Kita-gun</city>
        <state>Kagawa</state>
        <zip>761-0793</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #68</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #22</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #211</name>
      <address>
        <city>Natori-shi</city>
        <state>Miyagi</state>
        <zip>981-1293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #88</name>
      <address>
        <city>Chuo-Ku</city>
        <state>Osaka-shi</state>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #51</name>
      <address>
        <city>Hidaka</city>
        <state>Saitama</state>
        <zip>350-1298</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #216</name>
      <address>
        <city>Shizuoka City</city>
        <state>Shizuoka</state>
        <zip>420-8527</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #65</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #61</name>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <zip>755-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #78</name>
      <address>
        <city>Chiba</city>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #209</name>
      <address>
        <city>Fukuoka</city>
        <zip>815-8588</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #26</name>
      <address>
        <city>Nagano</city>
        <zip>381-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #75</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #32</name>
      <address>
        <city>Wakayama</city>
        <zip>641-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #81</name>
      <address>
        <city>Ōsaka-sayama</city>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #20</name>
      <address>
        <city>Junggu</city>
        <state>Daejeon</state>
        <zip>35015</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #49</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 #60</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-Do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #34</name>
      <address>
        <city>Hwasun</city>
        <state>Jeollanam-do</state>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #58</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #24</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #94</name>
      <address>
        <city>Daegu</city>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #21</name>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #40</name>
      <address>
        <city>Gwangju</city>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #59</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #46</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #25</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #48</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #206</name>
      <address>
        <city>Tuxtla Gutiérrez</city>
        <state>Chiapas</state>
        <zip>29038</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #187</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>06760</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #254</name>
      <address>
        <city>Leon</city>
        <state>Guanajuato</state>
        <zip>37178</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #212</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44500</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #173</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #219</name>
      <address>
        <city>Zapopan</city>
        <state>Jalisco</state>
        <zip>45040</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #257</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #172</name>
      <address>
        <city>Querétaro</city>
        <state>Queretaro</state>
        <zip>76070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #182</name>
      <address>
        <city>Querétaro</city>
        <state>Queretaro</state>
        <zip>76230</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #250</name>
      <address>
        <city>San Luis Potosí</city>
        <state>San Luis Potosi</state>
        <zip>78200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #184</name>
      <address>
        <city>San Luis Potosí</city>
        <state>San Luis Potosi</state>
        <zip>78209</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #208</name>
      <address>
        <city>Culiacán</city>
        <state>Sinaloa</state>
        <zip>C.P. 80020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #174</name>
      <address>
        <city>Mexico City</city>
        <zip>01120</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #272</name>
      <address>
        <city>Puebla</city>
        <zip>72530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #243</name>
      <address>
        <city>Otwock</city>
        <state>Mazowieckie</state>
        <zip>05-400</zip>
        <country>Poland</country>
      </address>
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    <facility>
      <name>Exelixis Clinical Site #82</name>
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        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
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    <facility>
      <name>Exelixis Clinical Site #89</name>
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        <city>Poznań</city>
        <zip>60-569</zip>
        <country>Poland</country>
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    <facility>
      <name>Exelixis Clinical #268</name>
      <address>
        <city>Łódź</city>
        <zip>93-513</zip>
        <country>Poland</country>
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    <facility>
      <name>Exelixis Clinical Site #110</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
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    <facility>
      <name>Exelixis Clinical Site #188</name>
      <address>
        <city>Guimarães</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
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    <facility>
      <name>Exelixis Site #164</name>
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        <city>Lisboa</city>
        <zip>1400-038</zip>
        <country>Portugal</country>
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      <name>Exelixis Clinical Site #197</name>
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        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
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      <name>Exelixis Clinical Site #196</name>
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        <city>Loures</city>
        <zip>2674-514</zip>
        <country>Portugal</country>
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    <facility>
      <name>Exelixis Clinical Site #56</name>
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        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
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    <facility>
      <name>Exelixis Clinical Site #223</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
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    <facility>
      <name>Exelixis Clinical Site #193</name>
      <address>
        <city>Vila Real</city>
        <zip>5000-508</zip>
        <country>Portugal</country>
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    <facility>
      <name>Exelixis Site #166</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
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    <facility>
      <name>Exelixis Clinical Site #137</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
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    <facility>
      <name>Exelixis Clinical Site #195</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
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    <facility>
      <name>Exelixis Clinical Site #50</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
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    <facility>
      <name>Exelixis Clinical Site #87</name>
      <address>
        <city>Singapore</city>
        <zip>258499</zip>
        <country>Singapore</country>
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    </facility>
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    <facility>
      <name>Exelixis Clinical Site #181</name>
      <address>
        <city>Singapore</city>
        <zip>329563</zip>
        <country>Singapore</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #229</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #225</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #12</name>
      <address>
        <city>Manresa</city>
        <state>Barcelona</state>
        <zip>08243</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #220</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Islas Baleares</state>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #233</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>La Coruna</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #17</name>
      <address>
        <city>Alcorcón</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #274</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #228</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #23</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #255</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #190</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #226</name>
      <address>
        <city>Cadiz</city>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #33</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #28</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #131</name>
      <address>
        <city>Madrid</city>
        <zip>28033</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #248</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #236</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #251</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #13</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #270</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #29</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #266</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #138</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #86</name>
      <address>
        <city>Taichung City</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #133</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #271</name>
      <address>
        <city>Tainan City</city>
        <zip>710</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #111</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #264</name>
      <address>
        <city>Taipei city</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical #265</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #102</name>
      <address>
        <city>Dnipro</city>
        <zip>49005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #186</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #76</name>
      <address>
        <city>Kyiv</city>
        <zip>02125</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #71</name>
      <address>
        <city>Luts'k</city>
        <zip>43018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #205</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #241</name>
      <address>
        <city>Somerset</city>
        <state>England</state>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #235</name>
      <address>
        <city>Surrey Quays</city>
        <state>England</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #249</name>
      <address>
        <city>Blackburn</city>
        <state>Lancashire</state>
        <zip>BB2 3HH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #231</name>
      <address>
        <city>Northwood</city>
        <state>Middlesex</state>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exelixis Clinical Site #194</name>
      <address>
        <city>Swansea</city>
        <state>Wales</state>
        <zip>SA2 Q8A</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>Chile</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>castration-resistant prostate cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Atezolizumab</mesh_term>
    <mesh_term>Abiraterone Acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04446117
org study id: XL184-315
nct id: NCT04446117
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 3, multi-center, randomized, open-label, controlled study designed to
      evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab
      versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant
      prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for
      their prostate cancer disease.
The primary objective of this study is to evaluate the efficacy of cabozantinib (XL184) in
      combination with atezolizumab versus a second NHT (abiraterone or enzalutamide) in subjects
      with mCRPC who have previously been treated with one, and only one, NHT (e.g. abiraterone,
      apalutamide, darolutamide, or enzalutamide) to treat metastatic castration-sensitive prostate
      cancer (mCSPC), non-metastatic CRPC (M0 CRPC), or mCRPC, and who have measurable extrapelvic
      disease. The multiple primary efficacy endpoints comparing the experimental arm and control
      arm are Duration of Progression Free Survival (PFS) per RECIST 1.1 by Blinded Independent
      Radiology Committee (BIRC) and Duration of Overall Survival (OS). The secondary efficacy
      endpoint is Objective Response Rate (ORR) per RECIST 1.1 per BIRC.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Approximately 580 eligible subjects will be randomized in a 1:1 fashion to the experimental arm receiving cabozantinib and atezolizumab in combination (290) or to the control arm receiving a second NHT (290).
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of Progression Free Survival per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)
time frame: Approximately 21 months after the first subject is randomized.
description: 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
measure: Duration of Overall Survival (OS)
time frame: Approximately 37 months after the first subject is randomized
description: Defined as time from randomization to date of death from any cause
measure: Objective response rate (ORR)
time frame: Approximately 37 months after the first subject is randomized
description: ORR per RECIST 1.1 by BIRC
arm group label: Experimental Arm
arm group type: Experimental
description: Subjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg infusion, q3w
arm group label: Control Arm
arm group type: Active Comparator
description: Subjects with mCRPC will receive active comparator of EITHER abiraterone 1000mg oral, qd + prednisone 5 mg oral, bid; OR enzalutamide 160mg oral, qd as designated by the Investigator prior to randomization
intervention type: Drug
intervention name: Cabozantinib
description: Supplied as 20-mg tablets; administered orally daily at 40mg
arm group label: Experimental Arm
other name: XL184
other name: Cabometyx®
intervention type: Drug
intervention name: Atezolizumab
description: Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)
arm group label: Experimental Arm
other name: Tecentriq®
intervention type: Drug
intervention name: Abiraterone Acetate
description: Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid
arm group label: Control Arm
other name: Abiraterone
other name: Zytiga
intervention type: Drug
intervention name: Enzalutamide
description: Supplied as 40 mg capsules; administered orally daily at 160mg
arm group label: Control Arm
other name: Xtandi
intervention type: Drug
intervention name: Prednisone
description: Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily
arm group label: Control Arm
criteria: 
gender: Male
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: Chile
country: Czechia
country: France
country: Georgia
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Poland
country: Portugal
country: Russian Federation
country: Singapore
country: Spain
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Atezolizumab
mesh term: Abiraterone Acetate
sharing ipd: No