<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/NCT04482309</url>
  </required_header>
  <id_info>
    <org_study_id>D967VC00001</org_study_id>
    <secondary_id>2020-001574-29</secondary_id>
    <nct_id>NCT04482309</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors</brief_title>
  <acronym>DPT02</acronym>
  <official_title>A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daiichi Sankyo Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</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 an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and&#xD;
      safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing&#xD;
      tumors.&#xD;
&#xD;
      This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical&#xD;
      cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.&#xD;
&#xD;
      Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a&#xD;
      favorable risk benefit profile in selected HER2-expressing solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2027</completion_date>
  <primary_completion_date type="Actual">June 8, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study will consist of seven cohorts of urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, Pancreatic cancer, and rare tumors.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This study is Open-Label Study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>An average of approximately 41 months</time_frame>
    <description>Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DoR)</measure>
    <time_frame>An average of approximately 41 months</time_frame>
    <description>DOR is defined as the time from the date of first documented response until the date of documented progression or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>An average of approximately 41 months</time_frame>
    <description>DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>An average of approximately 41 months</time_frame>
    <description>PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients alive and progression-free at 6 months and 12 months</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>An average of approximately 41 months</time_frame>
    <description>OS is the time from date of first dose of study treatment until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients alive at 6 and 12 months</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse events (AEs) and serious adverse events (SAEs)</measure>
    <time_frame>An average of approximately 41 months</time_frame>
    <description>Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181</measure>
    <time_frame>An average of approximately 41 months</time_frame>
    <description>Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd, total anti-HER2 antibody and MAAA-1181a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd</measure>
    <time_frame>An average of approximately 41 months</time_frame>
    <description>Individual participant data and descriptive statistics will be provided for data at each time point.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">468</enrollment>
  <condition>Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 1: Biliary tract cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 2: Bladder cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 3: Cervical cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 4: Endometrial cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 5: Ovarian cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 6: Pancreatic cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 7: Rare tumors</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab deruxtecan</intervention_name>
    <description>Trastuzumab deruxtecan by intravenous infusion</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_label>Arm 5</arm_group_label>
    <arm_group_label>Arm 6</arm_group_label>
    <arm_group_label>Arm 7</arm_group_label>
    <other_name>DS-8201a</other_name>
    <other_name>T-DXd</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Locally advanced, unresectable, or metastatic disease based on most recent imaging.&#xD;
&#xD;
          -  The respective cohorts for patient inclusion are:&#xD;
&#xD;
               -  Cohort 1: Biliary tract cancer&#xD;
&#xD;
               -  Cohort 2: Bladder cancer&#xD;
&#xD;
               -  Cohort 3: Cervical cancer&#xD;
&#xD;
               -  Cohort 4: Endometrial cancer&#xD;
&#xD;
               -  Cohort 5: Epithelial ovarian cancer&#xD;
&#xD;
               -  Cohort 6: Pancreatic cancer&#xD;
&#xD;
               -  Cohort 7: Rare tumors: This cohort will consist of patients with tumors that&#xD;
                  express HER2, excluding the tumors mentioned above, and breast, non-small cell&#xD;
                  lung cancer, gastric cancer, and colorectal cancer.&#xD;
&#xD;
          -  Progressed following prior treatment or who have no satisfactory alternative treatment&#xD;
             option.&#xD;
&#xD;
          -  Prior HER2 targeting therapy is permitted.&#xD;
&#xD;
          -  HER2 expression for eligibility may be based on local or central assessment.&#xD;
&#xD;
          -  Has measurable target disease assessed by the Investigator based on RECIST version&#xD;
             1.1.&#xD;
&#xD;
          -  Has protocol- defined adequate organ function including cardiac, renal and hepatic&#xD;
             function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of non-infectious pneumonitis/ILD that required steroids, current ILD, or&#xD;
             where suspected ILD that cannot be ruled out by imaging at screening&#xD;
&#xD;
          -  Lung-specific intercurrent clinically significant severe illnesses&#xD;
&#xD;
          -  Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or&#xD;
             antifungals&#xD;
&#xD;
          -  Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal&#xD;
             shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART&#xD;
&#xD;
          -  Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.&#xD;
&#xD;
          -  Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or&#xD;
             rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small&#xD;
             cell lung cancer.&#xD;
&#xD;
          -  Medical conditions that may interfere with the subject's participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Auchenflower</city>
        <zip>4066</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Camperdown</city>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quebec</city>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brno</city>
        <zip>656 53</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Olomouc</city>
        <zip>775 20</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Praha 8</city>
        <zip>180 81</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Delhi</city>
        <zip>110085</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gurgaon</city>
        <zip>122001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kolkata</city>
        <zip>700160</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mumbai</city>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milan</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milan</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rome</city>
        <zip>168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>5505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>6351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Delft</city>
        <zip>2625 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Groningen</city>
        <zip>9700</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kraków</city>
        <zip>30-688</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-780</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kaluga</city>
        <zip>248007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>115419</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>121205</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>143423</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>143442</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>195271</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
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      <name>Research Site</name>
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        <zip>8035</zip>
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        <zip>28027</zip>
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  <location>
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        <zip>SW2 6JJ</zip>
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      <name>Research Site</name>
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        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
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      <name>Research Site</name>
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        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
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  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>India</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
  </removed_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T-DXd, DS-8201a, Trastuzumab Deruxtecan, HER2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Trastuzumab deruxtecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.&#xD;
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.&#xD;
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool .&#xD;
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.&#xD;
For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </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/NCT04482309
org study id: D967VC00001
secondary id: 2020-001574-29
nct id: NCT04482309
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and
      safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing
      tumors.

      This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical
      cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.

      Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a
      favorable risk benefit profile in selected HER2-expressing solid tumors.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This study will consist of seven cohorts of urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, Pancreatic cancer, and rare tumors.
primary purpose: Treatment
masking: None (Open Label)
masking description: This study is Open-Label Study.
measure: Objective Response Rate (ORR)
time frame: An average of approximately 41 months
description: Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
measure: Duration of response (DoR)
time frame: An average of approximately 41 months
description: DOR is defined as the time from the date of first documented response until the date of documented progression or death.
measure: Disease control rate (DCR)
time frame: An average of approximately 41 months
description: DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).
measure: Progression free survival (PFS)
time frame: An average of approximately 41 months
description: PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.
measure: Proportion of patients alive and progression-free at 6 months and 12 months
time frame: Up to 12 months
description: The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates).
measure: Overall survival (OS)
time frame: An average of approximately 41 months
description: OS is the time from date of first dose of study treatment until death due to any cause.
measure: Proportion of patients alive at 6 and 12 months
time frame: Up to 12 months
description: The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates).
measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs)
time frame: An average of approximately 41 months
description: Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
measure: Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
time frame: An average of approximately 41 months
description: Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd, total anti-HER2 antibody and MAAA-1181a
measure: The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd
time frame: An average of approximately 41 months
description: Individual participant data and descriptive statistics will be provided for data at each time point.
arm group label: Arm 1
arm group type: Experimental
description: Cohort 1: Biliary tract cancer
arm group label: Arm 2
arm group type: Experimental
description: Cohort 2: Bladder cancer
arm group label: Arm 3
arm group type: Experimental
description: Cohort 3: Cervical cancer
arm group label: Arm 4
arm group type: Experimental
description: Cohort 4: Endometrial cancer
arm group label: Arm 5
arm group type: Experimental
description: Cohort 5: Ovarian cancer
arm group label: Arm 6
arm group type: Experimental
description: Cohort 6: Pancreatic cancer
arm group label: Arm 7
arm group type: Experimental
description: Cohort 7: Rare tumors
intervention type: Drug
intervention name: Trastuzumab deruxtecan
description: Trastuzumab deruxtecan by intravenous infusion
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
arm group label: Arm 5
arm group label: Arm 6
arm group label: Arm 7
other name: DS-8201a
other name: T-DXd
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
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country: Australia
country: Belgium
country: Canada
country: Czechia
country: India
country: Italy
country: Korea, Republic of
country: Netherlands
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: Thailand
country: United Kingdom
country: United States
country: Brazil
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Biliary Tract Neoplasms
mesh term: Trastuzumab
mesh term: Trastuzumab deruxtecan
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home