<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/NCT02228811</url>
  </required_header>
  <id_info>
    <org_study_id>DCC-2701-01-001</org_study_id>
    <nct_id>NCT02228811</nct_id>
  </id_info>
  <brief_title>A Study of DCC-2701 in Participants With Advanced Solid Tumors</brief_title>
  <official_title>A Multicenter Phase 1 Ascending Dose Study of DCC-2701 To Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Deciphera Pharmaceuticals LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Deciphera Pharmaceuticals LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to investigate the safety of the investigational drug&#xD;
      DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer&#xD;
      that has spread to other parts of the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine&#xD;
      what dose of DCC-2701, can be given safely to patients with advanced solid tumors.&#xD;
&#xD;
      The study will have two phases. The first phase will assess escalating doses of DCC-2701 in&#xD;
      order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of&#xD;
      DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate&#xD;
      the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Maximum Tolerated Dose (MTD) of DCC-2701</measure>
    <time_frame>28 days (1 cycle)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701</measure>
    <time_frame>Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701</measure>
    <time_frame>Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701</measure>
    <time_frame>Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Tumor Response according to Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1</measure>
    <time_frame>Baseline through study completion (estimated as 18 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Locally Advanced Tumors</condition>
  <condition>Metastatic Solid Tumors</condition>
  <condition>Cancers With MET Genomic Alterations</condition>
  <condition>Cancers With TRK Genomic Alterations</condition>
  <arm_group>
    <arm_group_label>DCC-2701 tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DCC-2701 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DCC-2701 tablet</intervention_name>
    <arm_group_label>DCC-2701 tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced or metastatic solid tumor that has progressed or was not responsive to&#xD;
             standard therapy&#xD;
&#xD;
          -  The cancer has no proven effective therapy&#xD;
&#xD;
          -  The cancer can be biopsied (depending on the tumor type and/or the dose of drug&#xD;
             received, tumor biopsies may be required)&#xD;
&#xD;
          -  Able to swallow tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have active central nervous system (CNS) metastasis&#xD;
&#xD;
          -  Have an active infection of any kind (fungal, viral, or bacterial)&#xD;
&#xD;
          -  Are pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oliver Rosen, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Deciphera Pharmaceuticals LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</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/NCT02228811
org study id: DCC-2701-01-001
nct id: NCT02228811
lead sponsor: 
has dmc: No
The main purpose of this study is to investigate the safety of the investigational drug
      DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer
      that has spread to other parts of the body.
This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine
      what dose of DCC-2701, can be given safely to patients with advanced solid tumors.

      The study will have two phases. The first phase will assess escalating doses of DCC-2701 in
      order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of
      DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate
      the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose (MTD) of DCC-2701
time frame: 28 days (1 cycle)
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of DCC-2701
time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
measure: Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of DCC-2701
time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of DCC-2701
time frame: Cycle 1: Predose and up to 24 hours postdose (Cycle = 28 Days)
measure: Number of Participants with Tumor Response according to Response Evaluations Criteria in Solid Tumors (RECIST) version 1.1
time frame: Baseline through study completion (estimated as 18 months)
arm group label: DCC-2701 tablet
arm group type: Experimental
description: DCC-2701 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
intervention type: Drug
intervention name: DCC-2701 tablet
arm group label: DCC-2701 tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oliver Rosen, M.D.
role: Study Director
affiliation: Deciphera Pharmaceuticals LLC
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms