<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/NCT01682473</url>
  </required_header>
  <id_info>
    <org_study_id>ZSTK474-201</org_study_id>
    <nct_id>NCT01682473</nct_id>
  </id_info>
  <brief_title>A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies</brief_title>
  <official_title>A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zenyaku Kogyo Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zenyaku Kogyo Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of&#xD;
      ZSTK474 in patients with advanced solid malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different&#xD;
      dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21&#xD;
      days on drug and 7 days off drug).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2012</start_date>
  <completion_date type="Actual">April 20, 2015</completion_date>
  <primary_completion_date type="Actual">April 2, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with dose-limiting toxicities</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (Cmax, tmax, t½, AUC)</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Arm 1: 5/2 Dosing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: 21/7 Dosing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZSTK474</intervention_name>
    <description>Two arms, each with serial cohorts receiving escalating doses.</description>
    <arm_group_label>Arm 1: 5/2 Dosing</arm_group_label>
    <arm_group_label>Arm 2: 21/7 Dosing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese males or females &gt;= 20 years old&#xD;
&#xD;
          -  Advanced (metastatic or unresectable) solid tumor&#xD;
&#xD;
          -  ECOG performance status score of 0 or 1 and expected survival &gt;12 weeks&#xD;
&#xD;
          -  Recovered from hematological toxicities of prior cancer therapies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with PI3K inhibitor&#xD;
&#xD;
          -  Serious/significant illnesses or underlying conditions, including diabetes or hepatic&#xD;
             renal or CV disease.&#xD;
&#xD;
          -  Other investigational agent within previous 4 weeks&#xD;
&#xD;
          -  Participating in another clinical study&#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>Toshihiko Doi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center Hospital East</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shunji Takahashi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cancer Institute Hospital of JFCR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa-city</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>July 3, 2017</last_update_submitted>
  <last_update_submitted_qc>July 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PI3K inhibitor</keyword>
  <keyword>clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01682473
org study id: ZSTK474-201
nct id: NCT01682473
lead sponsor: 
has dmc: Yes
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of
      ZSTK474 in patients with advanced solid malignancies.
Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different
      dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21
      days on drug and 7 days off drug).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with dose-limiting toxicities
time frame: 28 days
measure: Pharmacokinetics (Cmax, tmax, t½, AUC)
time frame: 28 days
arm group label: Arm 1: 5/2 Dosing
arm group type: Experimental
description: Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug.
arm group label: Arm 2: 21/7 Dosing
arm group type: Experimental
description: Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug.
intervention type: Drug
intervention name: ZSTK474
description: Two arms, each with serial cohorts receiving escalating doses.
arm group label: Arm 1: 5/2 Dosing
arm group label: Arm 2: 21/7 Dosing
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Toshihiko Doi, MD, PhD
role: Principal Investigator
affiliation: National Cancer Center Hospital East
last name: Shunji Takahashi, MD
role: Principal Investigator
affiliation: The Cancer Institute Hospital of JFCR
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Neoplasms