<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/NCT02261532</url>
  </required_header>
  <id_info>
    <org_study_id>10040100</org_study_id>
    <nct_id>NCT02261532</nct_id>
  </id_info>
  <brief_title>A Phase I Study of TAS-102 in Solid Tumors</brief_title>
  <official_title>A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taiho Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taiho Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after&#xD;
      single and multiple dose in Chinese patients with solid tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the&#xD;
      pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the&#xD;
      first cycle (Day1 and Day 12) of therapy in all consenting patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 1</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>Cmax (maximum plasma concentration) of FTD and TPI</measure>
    <time_frame>Multiple time points on Day 1 and Day 12 of Cycle 1.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax (time to reach maximum drug concentration in blood) of FTD and TPI</measure>
    <time_frame>Multiple time points on Day 1 and Day 12 of Cycle 1.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-t (area under the plasma concentration versus time curve from time 0 to time (t) of the last quantifiable concentration ) of FTD and TPI</measure>
    <time_frame>Multiple time points on Day 1 and Day 12 of Cycle 1.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-10 (area under the plasma concentration versus time curve from time 0 to 10 hours post dose) of FTD and TPI</measure>
    <time_frame>Multiple time points on Day 1 and Day 12 of Cycle 1.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf (area under the plasma concentration versus time curve from time 0 to infinity) of FTD and TPI</measure>
    <time_frame>Multiple time points on Day 1 and Day 12 of Cycle 1.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>T½ (half-life) of FTD and TPI</measure>
    <time_frame>Multiple time points on Day 1 and Day 12 of Cycle 1.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F (oral clearance) of FTD and TPI</measure>
    <time_frame>Multiple time points on Day 1 and Day 12 of Cycle 1.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vd/F (apparent volume of distribution) of FTD and TPI</measure>
    <time_frame>Multiple time points on Day 1 and Day 12 of Cycle 1.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as a measure of safety</measure>
    <time_frame>Through 30 days following last administration of study medication.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antitumor Activity (Response Rate)</measure>
    <time_frame>Average 8 weeks from Cycle 1 Day 1.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Advanced or Metastatic Solid Tumors</condition>
  <arm_group>
    <arm_group_label>TAS-102</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAS-102</intervention_name>
    <description>TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.</description>
    <arm_group_label>TAS-102</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Has provided written informed consent prior to performance of any study procedure.&#xD;
&#xD;
          -  2. Has definitive histologically or cytologically confirmed advanced or metastatic&#xD;
             solid tumor.&#xD;
&#xD;
          -  3. Is able to take medications orally.&#xD;
&#xD;
          -  4. Has adequate organ function (bone marrow, kidney and liver).&#xD;
&#xD;
          -  5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Has received TAS-102.&#xD;
&#xD;
          -  2. Has suffered serious complications.&#xD;
&#xD;
          -  3. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any&#xD;
             prior therapies.&#xD;
&#xD;
          -  4. Has had prior gastrectomy.&#xD;
&#xD;
          -  5. Is a pregnant or lactating female or male who refused using birth control during&#xD;
             the clinical trial period and within 6 months after discontinuation of study&#xD;
             treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taiho Pharmaceutical Co., Ltd selected site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</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>
  <!-- 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/NCT02261532
org study id: 10040100
nct id: NCT02261532
lead sponsor: 
has dmc: No
The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after
      single and multiple dose in Chinese patients with solid tumor.
This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the
      pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the
      first cycle (Day1 and Day 12) of therapy in all consenting patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax (maximum plasma concentration) of FTD and TPI
time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: Tmax (time to reach maximum drug concentration in blood) of FTD and TPI
time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: AUC0-t (area under the plasma concentration versus time curve from time 0 to time (t) of the last quantifiable concentration ) of FTD and TPI
time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: AUC0-10 (area under the plasma concentration versus time curve from time 0 to 10 hours post dose) of FTD and TPI
time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: AUCinf (area under the plasma concentration versus time curve from time 0 to infinity) of FTD and TPI
time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: T½ (half-life) of FTD and TPI
time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: CL/F (oral clearance) of FTD and TPI
time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: Vd/F (apparent volume of distribution) of FTD and TPI
time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.
measure: Number of participants with adverse events as a measure of safety
time frame: Through 30 days following last administration of study medication.
measure: Antitumor Activity (Response Rate)
time frame: Average 8 weeks from Cycle 1 Day 1.
arm group label: TAS-102
arm group type: Experimental
intervention type: Drug
intervention name: TAS-102
description: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
arm group label: TAS-102
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms