<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/NCT02990481</url>
  </required_header>
  <id_info>
    <org_study_id>950P1V01</org_study_id>
    <nct_id>NCT02990481</nct_id>
  </id_info>
  <brief_title>A Study of TRK-950 in Patients With Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toray Industries, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toray Industries, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of&#xD;
           TRK-950 as single agent&#xD;
&#xD;
        2. To establish the dose of TRK-950 recommended for future phase 2 studies&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is&#xD;
      primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose&#xD;
      (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28&#xD;
      days in Arm 1.&#xD;
&#xD;
      Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to&#xD;
      determine the dosing schedule. Up to six (6) patients will be enrolled respectively.&#xD;
&#xD;
      In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in&#xD;
      Arm 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">September 16, 2019</completion_date>
  <primary_completion_date type="Actual">September 16, 2019</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse event</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CTCAE version 4.03</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure (mmHg)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate (bpm)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory rate (bpm)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature (°F or °C)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight (lbs/kg)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Height (inches/cm)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Karnofsky performance status</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrocardiogram</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical laboratory tests</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration curve(AUC)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration(Cmax)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration(Tmax)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half life(t1/2)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body clearance(CL)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution(Vd)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Locally Advanced or Metastatic Solid Carcinomas</condition>
  <condition>Colon Cancer</condition>
  <condition>Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>Arm 1 - TRK-950</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Solid tumor&#xD;
TRK-950 (Three dose levels will be explored during Arm 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 - TRK-950</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colon cancer&#xD;
TRK-950 (Low dose and High dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3 -TRK-950</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cholangiocarcinomas&#xD;
TRK-950 (Low dose)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TRK-950</intervention_name>
    <description>Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle</description>
    <arm_group_label>Arm 1 - TRK-950</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TRK-950</intervention_name>
    <description>Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle&#xD;
High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle</description>
    <arm_group_label>Arm 2 - TRK-950</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TRK-950</intervention_name>
    <description>Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle</description>
    <arm_group_label>Arm 3 -TRK-950</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed locally advanced or metastatic solid carcinomas&#xD;
             in Arm 1&#xD;
&#xD;
          -  Patients with histologically confirmed locally advanced or metastatic colon cancer in&#xD;
             Arm 2&#xD;
&#xD;
          -  Patients with histologically confirmed locally advanced or metastatic&#xD;
             cholangiocarcinomas in Arm 3&#xD;
&#xD;
          -  Tumor progression after receiving standard/approved chemotherapy or where there is no&#xD;
             approved therapy or not amendable to a curative treatment&#xD;
&#xD;
          -  Measurable disease per RECIST 1.1 (primary or metastases)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  New York Heart Association Class III or IV, cardiac disease, myocardial infarction&#xD;
             within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG&#xD;
&#xD;
          -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic&#xD;
             therapy&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Treatment with radiation therapy, surgery, chemotherapy, immunotherapy, or&#xD;
             investigational therapy within four weeks prior to study entry&#xD;
&#xD;
          -  Unwillingness or inability to comply with procedures required in this protocol&#xD;
&#xD;
          -  Known active infection with HIV, hepatitis B, hepatitis C&#xD;
&#xD;
          -  Symptomatic brain metastases&#xD;
&#xD;
          -  Serious nonmalignant disease that could compromise protocol objectives in the opinion&#xD;
             of the investigator and/or the sponsor&#xD;
&#xD;
          -  Patients who are currently receiving any other investigational agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HonorHealth Research Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>October 14, 2021</last_update_submitted>
  <last_update_submitted_qc>October 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</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>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02990481
org study id: 950P1V01
nct id: NCT02990481
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of
           TRK-950 as single agent

        2. To establish the dose of TRK-950 recommended for future phase 2 studies
This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is
      primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose
      (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28
      days in Arm 1.

      Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to
      determine the dosing schedule. Up to six (6) patients will be enrolled respectively.

      In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in
      Arm 3.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse event
time frame: through study completion, an average of 1 year
measure: CTCAE version 4.03
time frame: through study completion, an average of 1 year
measure: Blood pressure (mmHg)
time frame: through study completion, an average of 1 year
measure: Heart rate (bpm)
time frame: through study completion, an average of 1 year
measure: Respiratory rate (bpm)
time frame: through study completion, an average of 1 year
measure: Temperature (°F or °C)
time frame: through study completion, an average of 1 year
measure: Weight (lbs/kg)
time frame: through study completion, an average of 1 year
measure: Height (inches/cm)
time frame: through study completion, an average of 1 year
measure: Karnofsky performance status
time frame: through study completion, an average of 1 year
measure: Electrocardiogram
time frame: through study completion, an average of 1 year
measure: Clinical laboratory tests
time frame: through study completion, an average of 1 year
measure: Area under the concentration curve(AUC)
time frame: through study completion, an average of 1 year
measure: Maximum plasma concentration(Cmax)
time frame: through study completion, an average of 1 year
measure: Time to maximum plasma concentration(Tmax)
time frame: through study completion, an average of 1 year
measure: Terminal elimination half life(t1/2)
time frame: through study completion, an average of 1 year
measure: Total body clearance(CL)
time frame: through study completion, an average of 1 year
measure: Apparent volume of distribution(Vd)
time frame: through study completion, an average of 1 year
measure: Tumor response rate
time frame: through study completion, an average of 1 year
measure: Duration of response
time frame: through study completion, an average of 1 year
measure: Time to progression
time frame: through study completion, an average of 1 year
measure: Progression free survival
time frame: through study completion, an average of 1 year
arm group label: Arm 1 - TRK-950
arm group type: Experimental
description: Solid tumor
TRK-950 (Three dose levels will be explored during Arm 1)
arm group label: Arm 2 - TRK-950
arm group type: Experimental
description: Colon cancer
TRK-950 (Low dose and High dose)
arm group label: Arm 3 -TRK-950
arm group type: Experimental
description: Cholangiocarcinomas
TRK-950 (Low dose)
intervention type: Biological
intervention name: TRK-950
description: Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
arm group label: Arm 1 - TRK-950
intervention type: Biological
intervention name: TRK-950
description: Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle
arm group label: Arm 2 - TRK-950
intervention type: Biological
intervention name: TRK-950
description: Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
arm group label: Arm 3 -TRK-950
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
country: United States
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
sharing ipd: No