<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/NCT02261285</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-4538-13</org_study_id>
    <nct_id>NCT02261285</nct_id>
  </id_info>
  <brief_title>ONO-4538 Phase I Study in Patients With Solid Tumor</brief_title>
  <official_title>ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Study in Solid Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ono Pharmaceutical Co. Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to&#xD;
      Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to&#xD;
      standard therapy or for whom no appropriate treatment is available.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PK outcome: Cmax of ONO-4538</measure>
    <time_frame>Approximately 3 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK outcome: Tmax of ONO-4538</measure>
    <time_frame>Approximately 3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety outcome: The number of subjects with overall adverse events</measure>
    <time_frame>Approximately 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety outcome: The number of deaths</measure>
    <time_frame>Approximately 3 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <condition>Recurrent Solid Tumors</condition>
  <arm_group>
    <arm_group_label>ONO-4538 1mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ONO-4538 3mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ONO-4538 10mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ONO-4538</intervention_name>
    <arm_group_label>ONO-4538 10mg/kg</arm_group_label>
    <arm_group_label>ONO-4538 1mg/kg</arm_group_label>
    <arm_group_label>ONO-4538 3mg/kg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥ 20 years of age&#xD;
&#xD;
          -  Histologically or cytologically confirmed solid tumor&#xD;
&#xD;
          -  Patients with advanced or recurrent solid tumors who are refractory or intolerant to&#xD;
             standard therapy or for whom no appropriate treatment is available&#xD;
&#xD;
          -  ECOG Performance Status is 0 to 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior severe hypersensitivity to another antibody product&#xD;
&#xD;
          -  Multiple primary cancers&#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>Mitsunobu Tanimoto</last_name>
    <role>Study Director</role>
    <affiliation>Ono Pharmaceutical Co. Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seongnam-si Clinical Site 105</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site 101</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site 102</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site 103</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Clinical Site 104</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>November 16, 2021</last_update_submitted>
  <last_update_submitted_qc>November 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2021</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>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_url>https://www.ono.co.jp/eng/rd/policy.html</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>September 1, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02261285
org study id: ONO-4538-13
nct id: NCT02261285
lead sponsor: 
has dmc: No
The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to
      Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to
      standard therapy or for whom no appropriate treatment is available.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PK outcome: Cmax of ONO-4538
time frame: Approximately 3 weeks
measure: PK outcome: Tmax of ONO-4538
time frame: Approximately 3 weeks
measure: Safety outcome: The number of subjects with overall adverse events
time frame: Approximately 3 weeks
measure: Safety outcome: The number of deaths
time frame: Approximately 3 weeks
arm group label: ONO-4538 1mg/kg
arm group type: Experimental
description: ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose
arm group label: ONO-4538 3mg/kg
arm group type: Experimental
description: ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose
arm group label: ONO-4538 10mg/kg
arm group type: Experimental
description: ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose
intervention type: Drug
intervention name: ONO-4538
arm group label: ONO-4538 10mg/kg
arm group label: ONO-4538 1mg/kg
arm group label: ONO-4538 3mg/kg
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Mitsunobu Tanimoto
role: Study Director
affiliation: Ono Pharmaceutical Co. Ltd
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Nivolumab
sharing ipd: Yes
ipd url: https://www.ono.co.jp/eng/rd/policy.html
submitted: September 1, 2023