xml: <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/NCT06011954</url>
    </required_header>
    <id_info>
      <org_study_id>7465-PV-0001</org_study_id>
      <nct_id>NCT06011954</nct_id>
    </id_info>
    <brief_title>A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection</brief_title>
    <official_title>Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Astellas Pharma Korea, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Seagen Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Astellas Pharma Inc</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining&#xD;
        (urothelial cancer). PADCEV Injection is now available to treat this cancer.&#xD;
  &#xD;
        People in this study will be adults in South Korea with locally advanced or metastatic&#xD;
        urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During&#xD;
        their care, the person's doctor will have prescribed PADCEV Injection and other medicines to&#xD;
        treat their cancer. People in the study will be treated according to their clinic's standard&#xD;
        practice. This study is about collecting information only.&#xD;
  &#xD;
        This study will survey people who know they are receiving PADCEV Injection. The aims of the&#xD;
        study are to check outcomes of treatment with PADCEV and record any medical problems during&#xD;
        the study.&#xD;
  &#xD;
        Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up&#xD;
        to 48 weeks (about 1 year) after their first dose. During this time, a person's medical&#xD;
        records will be reviewed to check for any medical problems and to follow the condition of&#xD;
        their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks,&#xD;
        records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV&#xD;
        Injection or until they start a different medicine for their cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2027</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 with an Adverse Event</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>Adverse events (AEs) will be summarized using MedDRA. An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with an adverse drug reaction (ADR)</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with a serious AE (SAE)</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>An AE is considered &quot;serious&quot; if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with a serious ADR (SADR)</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>An ADR is considered &quot;serious&quot; if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with an unexpected AE (UAE)</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with an unexpected ADR (UADR)</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>An UADR is defined as an unexpected adverse drug reaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with an important risk</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>An important risk is classified as an important identified risk and an important potential risk.&#xD;
  An identified risk is defined as the risk that correspond to undesirable clinical outcomes, with sufficient scientific evidence that the undesirable clinical outcome is caused by the drug.&quot;Important Identified Risks&quot; are identified risks that have the potential to affect the risk-benefit balance of a product.&#xD;
  An potential risk is defined as the risk that correspond to undesirable clinical outcomes, with some, but not sufficient, evidence to estimate that the undesirable clinical outcome is caused by the drug.&quot;Important Potential Risks&quot; are potential risks that have the potential to affect the risk-benefit balance of a product.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>Overall survival (OS) is defined as time from start of PADCEV to death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival</measure>
      <time_frame>Up to 48 weeks after the first administration of PADCEV</time_frame>
      <description>Progression free survival (PFS) is defined as time from start of PADCEV to progressive disease (PD) or death from any cause, whichever occurs first.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">235</enrollment>
    <condition>Urothelial Cancer</condition>
    <arm_group>
      <arm_group_label>PADCEV</arm_group_label>
      <description>Patients who receive PADCEV Injection 20 mg and 30 mg (enfortumab vedotin) in routine clinical practice according to the drug label approved at the time of marketing authorization.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Enfortumab Vedotin</intervention_name>
      <description>Intravenous</description>
      <arm_group_label>PADCEV</arm_group_label>
      <other_name>PADCEV</other_name>
      <other_name>ASG-22CE</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with locally advanced or metastatic urothelial cancer who are prescribed PADCEV&#xD;
          Injection and have previously received a Programmed death receptor-1 or Programmed&#xD;
          death-ligand 1 inhibitor, and have received a platinum containing chemotherapy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who receive treatment with PADCEV Injection, according to the approved local&#xD;
               label.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with any contraindication for PADCEV Injection, according to the approved&#xD;
               local label.&#xD;
  &#xD;
            -  Patients who receive or are going to receive any investigational medicine during the&#xD;
               observation period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Central Contact</last_name>
      <role>Study Director</role>
      <affiliation>Astellas Pharma Korea, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Astellas Pharma Global Development, Inc.</last_name>
      <phone>800-888-7704</phone>
      <email>astellas.registration@astellas.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>KR82004</name>
        <address>
          <city>Seoul</city>
          <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>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Urothelial Cancer</keyword>
    <keyword>Bladder Cancer</keyword>
    <keyword>enfortumab vedotin</keyword>
    <keyword>PADCEV</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011954
  org study id: 7465-PV-0001
  nct id: NCT06011954
  lead sponsor: 
  collaborator: 
  has dmc: No
  Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining
        (urothelial cancer). PADCEV Injection is now available to treat this cancer.
  
        People in this study will be adults in South Korea with locally advanced or metastatic
        urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During
        their care, the person's doctor will have prescribed PADCEV Injection and other medicines to
        treat their cancer. People in the study will be treated according to their clinic's standard
        practice. This study is about collecting information only.
  
        This study will survey people who know they are receiving PADCEV Injection. The aims of the
        study are to check outcomes of treatment with PADCEV and record any medical problems during
        the study.
  
        Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up
        to 48 weeks (about 1 year) after their first dose. During this time, a person's medical
        records will be reviewed to check for any medical problems and to follow the condition of
        their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks,
        records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV
        Injection or until they start a different medicine for their cancer.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of patients with an Adverse Event
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: Adverse events (AEs) will be summarized using MedDRA. An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
  measure: Number of patients with an adverse drug reaction (ADR)
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility.
  measure: Number of patients with a serious AE (SAE)
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: An AE is considered "serious" if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.
  measure: Number of patients with a serious ADR (SADR)
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: An ADR is considered "serious" if it results in death or is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction.
  measure: Number of patients with an unexpected AE (UAE)
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: An UAE is an AE that the nature or severity of which is not consistent with the information in the approved Korean label.
  measure: Number of patients with an unexpected ADR (UADR)
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: An UADR is defined as an unexpected adverse drug reaction.
  measure: Number of patients with an important risk
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: An important risk is classified as an important identified risk and an important potential risk.
  An identified risk is defined as the risk that correspond to undesirable clinical outcomes, with sufficient scientific evidence that the undesirable clinical outcome is caused by the drug."Important Identified Risks" are identified risks that have the potential to affect the risk-benefit balance of a product.
  An potential risk is defined as the risk that correspond to undesirable clinical outcomes, with some, but not sufficient, evidence to estimate that the undesirable clinical outcome is caused by the drug."Important Potential Risks" are potential risks that have the potential to affect the risk-benefit balance of a product.
  measure: Overall survival
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: Overall survival (OS) is defined as time from start of PADCEV to death.
  measure: Progression free survival
  time frame: Up to 48 weeks after the first administration of PADCEV
  description: Progression free survival (PFS) is defined as time from start of PADCEV to progressive disease (PD) or death from any cause, whichever occurs first.
  arm group label: PADCEV
  description: Patients who receive PADCEV Injection 20 mg and 30 mg (enfortumab vedotin) in routine clinical practice according to the drug label approved at the time of marketing authorization.
  intervention type: Drug
  intervention name: Enfortumab Vedotin
  description: Intravenous
  arm group label: PADCEV
  other name: PADCEV
  other name: ASG-22CE
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Central Contact
  role: Study Director
  affiliation: Astellas Pharma Korea, Inc.
  last name: Astellas Pharma Global Development, Inc.
  phone: 800-888-7704
  email: astellas.registration@astellas.com
  facility: 
  status: Recruiting
  country: Korea, Republic of
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas.