<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/NCT04458272</url>
  </required_header>
  <id_info>
    <org_study_id>DS1001-A-J201</org_study_id>
    <secondary_id>205339</secondary_id>
    <nct_id>NCT04458272</nct_id>
  </id_info>
  <brief_title>A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma</brief_title>
  <official_title>A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma</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>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 Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients&#xD;
      with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>Phase 2</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>Overall response rate (ORR) assessed by Independent Efficacy Review Committee</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with treatment-emergent adverse events (TEAEs) during the study</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical benefit rate</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change in tumor volume</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment failure</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Through the end of the study (up to approximately 6 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration curve (AUC) for DS-1001a</measure>
    <time_frame>Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax) for DS-1001a</measure>
    <time_frame>Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration (Tmax) for DS-1001a</measure>
    <time_frame>Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)</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>Through the end of the study (up to approximately 6 years)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>WHO Grade II Glioma</condition>
  <arm_group>
    <arm_group_label>DS-1001b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS-1001b</intervention_name>
    <description>250 mg, twice daily, continuous oral administration</description>
    <arm_group_label>DS-1001b</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the&#xD;
             2016 WHO classification.&#xD;
&#xD;
          -  Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory&#xD;
             conducted during the screening period.&#xD;
&#xD;
          -  Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma&#xD;
             except craniotomy or biopsy.&#xD;
&#xD;
          -  Has at least 1 measurable and non-enhancing lesion.&#xD;
&#xD;
          -  Has an interval of at least 90 days from the latest surgery.&#xD;
&#xD;
          -  Has no sign of malignant transformation including the appearance of enhancing lesions&#xD;
             and/or rapid growth of non-enhancing lesions.&#xD;
&#xD;
          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has had a histopathological diagnosis of WHO grade III or IV glioma.&#xD;
&#xD;
          -  Has had a contrast enhancing lesion on brain MRI.&#xD;
&#xD;
          -  Has received a prior treatment with any mutant IDH1 inhibitor.&#xD;
&#xD;
          -  Has received other investigational products within 28 days before the start of the&#xD;
             study drug treatment.&#xD;
&#xD;
          -  Has an active infection requiring systemic treatment.&#xD;
&#xD;
          -  Has multiple primary malignancies.&#xD;
&#xD;
          -  Has a history of clinically significant cardiac disease.&#xD;
&#xD;
          -  Is a pregnant or lactating woman.&#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>Clinical Study Leader</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitasato University Hospital</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Hidaka</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Osaka National Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DS-1001</keyword>
  <keyword>IDH1</keyword>
  <keyword>Glioma</keyword>
  <keyword>IDH-mutant glioma</keyword>
  <keyword>WHO grade II glioma</keyword>
  <keyword>Low-grade 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/NCT04458272
org study id: DS1001-A-J201
secondary id: 205339
nct id: NCT04458272
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients
      with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR) assessed by Independent Efficacy Review Committee
time frame: Through the end of the study (up to approximately 6 years)
measure: Number of participants with treatment-emergent adverse events (TEAEs) during the study
time frame: Through the end of the study (up to approximately 6 years)
measure: Clinical benefit rate
time frame: Through the end of the study (up to approximately 6 years)
measure: Percentage change in tumor volume
time frame: Through the end of the study (up to approximately 6 years)
measure: Time to response
time frame: Through the end of the study (up to approximately 6 years)
measure: Duration of response
time frame: Through the end of the study (up to approximately 6 years)
measure: Time to treatment failure
time frame: Through the end of the study (up to approximately 6 years)
measure: Progression-free survival
time frame: Through the end of the study (up to approximately 6 years)
measure: Overall survival
time frame: Through the end of the study (up to approximately 6 years)
measure: Area under the concentration curve (AUC) for DS-1001a
time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
measure: Maximum plasma concentration (Cmax) for DS-1001a
time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
measure: Time to maximum plasma concentration (Tmax) for DS-1001a
time frame: Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days)
measure: Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
time frame: Through the end of the study (up to approximately 6 years)
arm group label: DS-1001b
arm group type: Experimental
intervention type: Drug
intervention name: DS-1001b
description: 250 mg, twice daily, continuous oral administration
arm group label: DS-1001b
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Study Leader
role: Study Director
affiliation: Daiichi Sankyo, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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/