<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/NCT03030066</url>
  </required_header>
  <id_info>
    <org_study_id>DS1001-A-J101</org_study_id>
    <secondary_id>163479</secondary_id>
    <nct_id>NCT03030066</nct_id>
  </id_info>
  <brief_title>Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas</brief_title>
  <official_title>A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics&#xD;
      (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132&#xD;
      mutations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Anticipated">March 2026</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants with dose limiting toxicities</measure>
    <time_frame>21 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants experiencing an adverse event (AE)</measure>
    <time_frame>up to 36 months</time_frame>
    <description>AEs temporally associated with DS-1001b treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration curve (AUC) for DS-1001b</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax) for DS-1001b</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration (Tmax) for DS-1001b</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b</measure>
    <time_frame>Baseline, up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)</measure>
    <time_frame>up to 36 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Glioma</condition>
  <arm_group>
    <arm_group_label>Experimental Drug DS-1001b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS-1001b</intervention_name>
    <description>Generic not assigned</description>
    <arm_group_label>Experimental Drug DS-1001b</arm_group_label>
    <other_name>Investigational</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has histologically confirmed glioma with an IDH1-R132 mutation&#xD;
&#xD;
          2. Has disease that has recurred or progressed following standard treatment including&#xD;
             radiotherapy&#xD;
&#xD;
          3. Has measurable lesion(s) as per RANO criteria&#xD;
&#xD;
          4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has significant symptoms of increased intracranial pressure&#xD;
&#xD;
          2. Has another active neoplasm&#xD;
&#xD;
          3. Has active infection requiring systemic treatment&#xD;
&#xD;
          4. Has a history of severe cardiac disease&#xD;
&#xD;
          5. Has had prior treatment with any inhibitor targeting mutant IDH1&#xD;
&#xD;
          6. Has had investigational drug treatment within 4 weeks prior to the first dose of study&#xD;
             treatment&#xD;
&#xD;
          7. Is a pregnant or lactating female&#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>Global Clinical Leader</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DS-1001b</keyword>
  <keyword>IDH1 mutation</keyword>
  <keyword>Developmental Phase I</keyword>
  <keyword>Glioma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/daiichi-sankyo/</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/NCT03030066
org study id: DS1001-A-J101
secondary id: 163479
nct id: NCT03030066
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics
      (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132
      mutations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Percentage of participants with dose limiting toxicities
time frame: 21 days
measure: Percentage of participants experiencing an adverse event (AE)
time frame: up to 36 months
description: AEs temporally associated with DS-1001b treatment
measure: Area under the concentration curve (AUC) for DS-1001b
time frame: up to 36 months
measure: Maximum plasma concentration (Cmax) for DS-1001b
time frame: up to 36 months
measure: Time to maximum plasma concentration (Tmax) for DS-1001b
time frame: up to 36 months
measure: Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
time frame: Baseline, up to 36 months
measure: Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)
time frame: up to 36 months
arm group label: Experimental Drug DS-1001b
arm group type: Experimental
description: Oral administration
intervention type: Drug
intervention name: DS-1001b
description: Generic not assigned
arm group label: Experimental Drug DS-1001b
other name: Investigational
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Leader
role: Study Director
affiliation: Daiichi Sankyo, Inc.
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Glioma
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
ipd access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
ipd url: https://vivli.org/ourmember/daiichi-sankyo/