<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/NCT02261298</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-4538-14</org_study_id>
    <nct_id>NCT02261298</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 Multiple Dose 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 this study is to investigate the safety, pharmacokinetics, pharmacology and&#xD;
      efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors&#xD;
      who are refractory or intolerant to standard therapy or for whom no appropriate treatment is&#xD;
      available.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">April 2020</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Safety outcome: The number of subjects with overall adverse events</measure>
    <time_frame>Approximately 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety outcome: The number of deaths</measure>
    <time_frame>Approximately 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK outcome: Cmax of ONO-4538</measure>
    <time_frame>Approximately 10 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy outcome: Response rate</measure>
    <time_frame>Approximately 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy outcome: Progression free survival</measure>
    <time_frame>Approximately 6 months</time_frame>
  </primary_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, 3 times once every 2 weeks in each 6-week cycle</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, 3 times once every 2 weeks in each 6-week cycle</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, 3 times once every 2 weeks in each 6-week cycle</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;
          -  The treatment phase has been completed in the ONO-4538-13 study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The development of PD is identified by the principal or sub investigator according to&#xD;
             the RECIST guideline (version 1.1) only in case in which the unplanned tumor&#xD;
             assessment with diagnostic image is performed in the treatment phase of ONO-4538-13&#xD;
             study.&#xD;
&#xD;
          -  It is determined that continuing the treatment is not appropriate because the&#xD;
             worsening of clinical symptoms attributed to disease progression occurs.&#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 2020</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>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 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>
  <!-- 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/NCT02261298
org study id: ONO-4538-14
nct id: NCT02261298
lead sponsor: 
has dmc: No
The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and
      efficacy 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: Safety outcome: The number of subjects with overall adverse events
time frame: Approximately 6 months
measure: Safety outcome: The number of deaths
time frame: Approximately 6 months
measure: PK outcome: Cmax of ONO-4538
time frame: Approximately 10 months
measure: Efficacy outcome: Response rate
time frame: Approximately 6 months
measure: Efficacy outcome: Progression free survival
time frame: Approximately 6 months
arm group label: ONO-4538 1mg/kg
arm group type: Experimental
description: ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle
arm group label: ONO-4538 3mg/kg
arm group type: Experimental
description: ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle
arm group label: ONO-4538 10mg/kg
arm group type: Experimental
description: ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle
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