<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/NCT03776123</url>
  </required_header>
  <id_info>
    <org_study_id>A-KR-60000-021</org_study_id>
    <nct_id>NCT03776123</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance to Observe Safety and Effectiveness of CABOMETYX™ in Korea.</brief_title>
  <official_title>Prospective, Post Marketing Surveillance to Observe Safety and Effectiveness of CABOMETYX™ Under the Real Practice Setting in Patients With Renal Cell Carcinoma and Patients With Hepatocellular Carcinoma in Korea.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ipsen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and&#xD;
      effectiveness profile of Cabometyx™ in real clinical practice setting, according to the&#xD;
      approved labelling after the approval of marketing authorization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration</measure>
    <time_frame>From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients who had AEs/SAE after Cabometyx™ administration</measure>
    <time_frame>From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of AEs/SAEs after Cabometyx™ administration</measure>
    <time_frame>From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">333</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients administrated Cabometyx™ at the site (Institutions)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who meet 'Indications' of label for Cabometyx™ as monotherapy&#xD;
&#xD;
          -  Patients who are treated with Cabometyx™ for the first time according to label for&#xD;
             Cabometyx™ as monotherapy&#xD;
&#xD;
          -  Patients who are aged 18 years or older&#xD;
&#xD;
          -  Patients who are willing to provide written consent after being informed of this&#xD;
             surveillance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ipsen Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ipsen Recruitment Enquiries</last_name>
    <phone>see email</phone>
    <email>clinical.trials@ipsen.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan</city>
        <zip>15355</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Anyang</city>
        <zip>14068</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DONG-A University Hospital (Site A)</name>
      <address>
        <city>Busan</city>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>DONG-A University Hospital (Site B)</name>
      <address>
        <city>Busan</city>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Chungbuk</city>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Chilgok Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>42472</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Hospital (Site A)</name>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Hospital (Site B)</name>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Daejeon ST.Mary's Hospital</name>
      <address>
        <city>Daejeon</city>
        <zip>34943</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <zip>35015</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Daejeon Eulji Medical center, Eulji University</name>
      <address>
        <city>Daejeon</city>
        <zip>35233</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Konyang University Hospital</name>
      <address>
        <city>Daejeon</city>
        <zip>35365</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uijeongbu Eulji Medical Center, Eulji University</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>11749</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (site A)</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>11765</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Uijeongbu ST. Mary's Hospital (Site B)</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>11765</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wonkwang University Hospital</name>
      <address>
        <city>Iksan</city>
        <zip>54538</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Mary's Hospital</name>
      <address>
        <city>Incheon</city>
        <zip>21431</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital</name>
      <address>
        <city>Pusan</city>
        <zip>04551</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Pusan</city>
        <zip>48108</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital (Site A)</name>
      <address>
        <city>Pusan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital (Site B)</name>
      <address>
        <city>Pusan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kosin University Gospel Hospital (Site A)</name>
      <address>
        <city>Pusan</city>
        <zip>49267</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kosin University Gospel Hospital (Site B)</name>
      <address>
        <city>Pusan</city>
        <zip>49267</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University</name>
      <address>
        <city>Seongnam</city>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inje University Sanggye Paik Hospital (Site A)</name>
      <address>
        <city>Seoul</city>
        <zip>01757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Inje University Sanggye Paik Hospital (Site B)</name>
      <address>
        <city>Seoul</city>
        <zip>01757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital (Site A)</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital (Site B)</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University (Site A)</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University (Site B)</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hanyang University Seoul Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>04763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gangdong Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>05278</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center (Site A)</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center (Site B)</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samsung medical center (Site B)</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center (Site C)</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center (Site D)</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Centre (Site A)</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chung-Ang University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06973</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Yeouido St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>07345</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Vincent's Hospital</name>
      <address>
        <city>Suwon</city>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03776123
org study id: A-KR-60000-021
nct id: NCT03776123
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and
      effectiveness profile of Cabometyx™ in real clinical practice setting, according to the
      approved labelling after the approval of marketing authorization.
observational model: Cohort
time perspective: Prospective
measure: Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration
time frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
measure: Proportion of patients who had AEs/SAE after Cabometyx™ administration
time frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
measure: Number of AEs/SAEs after Cabometyx™ administration
time frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
measure: Objective response rate
time frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
measure: Progression Free Survival
time frame: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ipsen Medical Director
role: Study Director
affiliation: Ipsen
last name: Ipsen Recruitment Enquiries
phone: see email
email: clinical.trials@ipsen.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Carcinoma, Renal Cell