<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/NCT03017521</url>
  </required_header>
  <id_info>
    <org_study_id>4-2016-0743</org_study_id>
    <nct_id>NCT03017521</nct_id>
  </id_info>
  <brief_title>K-BASKET, TAS-117, PI3K/AKT Gene Aberration</brief_title>
  <official_title>A Phase II Study of TAS-117 in Advanced Solid Tumors With PI3K/AKT Gene Aberration (Part of K-BASKET Trial; Korea-Biomarker-driven Multi-arm Drug-screening, Knowledge and Evidence-generating Targeted Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog&#xD;
      (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently&#xD;
      aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral&#xD;
      allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent&#xD;
      anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose&#xD;
      to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with&#xD;
      advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of&#xD;
      K-BASKET trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Solid Tumor, Adult</condition>
  <arm_group>
    <arm_group_label>TAS-117</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAS-117, 16mg, orally, daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAS-117</intervention_name>
    <description>TAS-117 16mg, daily</description>
    <arm_group_label>TAS-117</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed recurrent or advanced solid cancers with&#xD;
             PI3K/ATK aberration&#xD;
&#xD;
          2. Progressive disease who failed to previous standard treatment.&#xD;
&#xD;
          3. At least one measurable lesion according to Response Evaluation Criteria in Solid&#xD;
             Tumors version 1.1 criteria&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group performance status 0 or 1&#xD;
&#xD;
          5. Able to take medications orally&#xD;
&#xD;
          6. Adequate organ function&#xD;
&#xD;
          7. A life expectancy of at least 60 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous treatment with anti-PI3K or AKT directed therapies&#xD;
&#xD;
          2. Known hypersensitivity to any drugs similar to TAS-117 in structure or class.&#xD;
&#xD;
          3. History or current evidence of type 1 or type 2 diabetes mellitus that requires&#xD;
             insulin and/or oral antidiabetic therapy.&#xD;
&#xD;
          4. Current evidence of retinopathy that requires ophthalmological therapy.&#xD;
&#xD;
          5. History or current evidence of cardiac arrhythmia and/or conduction abnormality.&#xD;
&#xD;
          6. Treatment with any of the following within the specified time frame prior to study&#xD;
             drug administration:&#xD;
&#xD;
               -  Major surgery within prior 4 weeks&#xD;
&#xD;
               -  Radiation therapy for extended field within 4 weeks prior to study drug&#xD;
                  administration or limited field radiation therapy within 2 weeks prior to study&#xD;
                  drug administration.&#xD;
&#xD;
               -  Any anticancer treatment within 3 weeks prior to study drug administration&#xD;
                  (mitomycin within prior 5 weeks).&#xD;
&#xD;
          7. A serious illness or medical condition(s)&#xD;
&#xD;
          8. Unresolved toxicity of Grade &gt;1 attributed to any prior therapies (excluding alopecia,&#xD;
             skin pigmentation and anemia).&#xD;
&#xD;
          9. Patients with the risk of hypokalemia&#xD;
&#xD;
         10. Receiving oral steroid medication.&#xD;
&#xD;
         11. Pregnant or lactating female&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yonsei University</investigator_affiliation>
    <investigator_full_name>Minkyu Jung</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Refractory solid tumors</keyword>
  <keyword>AKT inhibitor</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03017521
org study id: 4-2016-0743
nct id: NCT03017521
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog
      (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently
      aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral
      allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent
      anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose
      to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with
      advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of
      K-BASKET trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: overall response rate
time frame: 2 months
arm group label: TAS-117
arm group type: Experimental
description: TAS-117, 16mg, orally, daily
intervention type: Drug
intervention name: TAS-117
description: TAS-117 16mg, daily
arm group label: TAS-117
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yonsei University
investigator full name: Minkyu Jung
investigator title: Assistant Professor
sharing ipd: Undecided