<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/NCT02192567</url>
  </required_header>
  <id_info>
    <org_study_id>DS5573-A-J101</org_study_id>
    <nct_id>NCT02192567</nct_id>
  </id_info>
  <brief_title>Open Label Study of DS-5573a</brief_title>
  <official_title>Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients With Advanced Solid Malignant Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, sequential dose escalation and expansion study to evaluate the safety,&#xD;
      and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business decision&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects experiencing dose limiting toxicities</measure>
    <time_frame>Day 1 through Day 28</time_frame>
    <description>Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects experiencing adverse events</measure>
    <time_frame>Day 1 through 45 days after last dose</time_frame>
    <description>Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic profile of DS-5573a</measure>
    <time_frame>Cycle 1 - Day 1 through Cycle 8 - Day 1</time_frame>
    <description>Pharmacokinetic profile of DS-5573a. [Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of human anti-human antibodies (HAHA) against DS-5573a</measure>
    <time_frame>Cycle 1 - Day 1 through Cycle 1 - Day 15.</time_frame>
    <description>Incidence of human anti-human antibodies (HAHA) against DS-5573a.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tumor response to DS-5573a using RECIST ver1.1.</measure>
    <time_frame>week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90</time_frame>
    <description>Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of DS-5573a-related biomarkers in blood and tumor</measure>
    <time_frame>Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2</time_frame>
    <description>Assessment of DS-5573a-related biomarkers in blood and tumor.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Advanced Solid Malignant Tumors</condition>
  <arm_group>
    <arm_group_label>DS-5573a does escalation (step 1) and expansion (step 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Step 1 of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg.&#xD;
Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg Step 2: 30 subjects will be enrolled and treated at the dose determined in Step 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS-5573a</intervention_name>
    <description>Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg.&#xD;
Step 2: 30 subjects will use the dose determined in Step 1.</description>
    <arm_group_label>DS-5573a does escalation (step 1) and expansion (step 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced solid tumor that is refractory to standard treatment, or for which no&#xD;
             standard treatment is available.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status(PS) of 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any of the following concomitant disease or had the history of having following&#xD;
             disease within 6 months before enrollment:&#xD;
&#xD;
        Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable&#xD;
        angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery,&#xD;
        cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or&#xD;
        clinically severe thromboembolic event, or autoimmune disorders requiring treatment.&#xD;
&#xD;
          -  Severe or uncontrolled concomitant disease.&#xD;
&#xD;
          -  Clinically active brain metastases defined as symptomatic or requiring treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenji Tamura, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced solid malignant tumor</keyword>
  <keyword>phase 1</keyword>
  <keyword>oncology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT02192567
org study id: DS5573-A-J101
nct id: NCT02192567
lead sponsor: 
has dmc: Yes
This is an open-label, sequential dose escalation and expansion study to evaluate the safety,
      and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects experiencing dose limiting toxicities
time frame: Day 1 through Day 28
description: Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.
measure: Number of subjects experiencing adverse events
time frame: Day 1 through 45 days after last dose
description: Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.
measure: Pharmacokinetic profile of DS-5573a
time frame: Cycle 1 - Day 1 through Cycle 8 - Day 1
description: Pharmacokinetic profile of DS-5573a. [Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors.
measure: Incidence of human anti-human antibodies (HAHA) against DS-5573a
time frame: Cycle 1 - Day 1 through Cycle 1 - Day 15.
description: Incidence of human anti-human antibodies (HAHA) against DS-5573a.
measure: Assessment of tumor response to DS-5573a using RECIST ver1.1.
time frame: week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90
description: Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation.
measure: Assessment of DS-5573a-related biomarkers in blood and tumor
time frame: Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2
description: Assessment of DS-5573a-related biomarkers in blood and tumor.
arm group label: DS-5573a does escalation (step 1) and expansion (step 2)
arm group type: Experimental
description: Step 1 of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg.
Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg Step 2: 30 subjects will be enrolled and treated at the dose determined in Step 1.
intervention type: Drug
intervention name: DS-5573a
description: Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg.
Step 2: 30 subjects will use the dose determined in Step 1.
arm group label: DS-5573a does escalation (step 1) and expansion (step 2)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Kenji Tamura, MD
role: Principal Investigator
affiliation: National Cancer Center Hospital
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Neoplasms