<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/NCT02257619</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 39110-203</org_study_id>
    <nct_id>NCT02257619</nct_id>
  </id_info>
  <brief_title>Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Randomized, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study is to evaluate the safety and tolerability of itacitinib&#xD;
      in combination with docetaxel and to select doses for further evaluation (Part 1, safety&#xD;
      run-in portion).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sponsor decision to not initiate part 2 of the trial and Part 2 of the study was not&#xD;
      conducted.&#xD;
&#xD;
      In Part 2, the randomized portion, the objective is to evaluate and compare the overall&#xD;
      survival of subjects with previously treated advanced or metastatic non-small cell lung&#xD;
      cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel&#xD;
      alone.&#xD;
&#xD;
      The secondary objectives of this study (Part 2) are to evaluate and compare the efficacy of&#xD;
      the 2 treatment groups with respect to progression-free survival, overall tumor response, and&#xD;
      duration of response, and to evaluate and compare disease control, safety, and tolerability&#xD;
      of itacitinib in combination with docetaxel versus docetaxel alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision to not initiate part 2 due to slow enrollment and competing trials.&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Number of Participants With Dose Limiting Toxicities (DLTs)</measure>
    <time_frame>Baseline through 21 days; the end of cycle 1.</time_frame>
    <description>Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>NSCLC (Non-small Cell Lung Carcinoma)</condition>
  <arm_group>
    <arm_group_label>Itacitinib plus docetaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itacitinib</intervention_name>
    <description>Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.</description>
    <arm_group_label>Itacitinib plus docetaxel</arm_group_label>
    <other_name>INCB039110</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>docetaxel</intervention_name>
    <description>Administered as an intravenous infusion in the clinic at 75 mg/m^2 Q3W for Part 1 of the study.</description>
    <arm_group_label>Itacitinib plus docetaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV,&#xD;
             or recurrent.&#xD;
&#xD;
          2. Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent&#xD;
             disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be&#xD;
             allowed based on prior treatment regimens and tumor types in agreement with protocol&#xD;
             requirements.)&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.&#xD;
&#xD;
          4. Life expectancy of ≥12 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received prior treatment with docetaxel.&#xD;
&#xD;
          2. Known active central nervous system (CNS) metastases. Subjects with CNS metastases who&#xD;
             have completed a course of therapy would be eligible for the study provided they are&#xD;
             clinically stable for at least 1 month prior to study entry, defined as:&#xD;
&#xD;
               1. No evidence of new or enlarging CNS metastasis or new neurological symptoms&#xD;
                  attributable to CNS metastases.&#xD;
&#xD;
               2. Subjects who are receiving concomitant corticosteroids must be on a stable or&#xD;
                  decreasing dose for at least 4 weeks prior to first dose of study treatment and&#xD;
                  off all anticonvulsants for at least 4 weeks prior to study entry.&#xD;
&#xD;
          3. Peripheral neuropathy ≥ Grade 3.&#xD;
&#xD;
          4. Current or previous other malignancy within 2 years of study entry, except cured basal&#xD;
             or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial&#xD;
             neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.&#xD;
&#xD;
          5. Significant, concurrent, uncontrolled medical condition including but not limited to,&#xD;
             renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,&#xD;
             neurological, cerebral, or psychiatric disease.&#xD;
&#xD;
          6. Unwilling to be transfused with blood components.&#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>Amit Pande, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Hot Springs</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pascagoula</city>
        <state>Mississippi</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gettysburg</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pawtucket</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <disposition_first_submitted>December 5, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>December 5, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 6, 2016</disposition_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02257619
org study id: INCB 39110-203
nct id: NCT02257619
lead sponsor: 
has dmc: No
The primary objectives of this study is to evaluate the safety and tolerability of itacitinib
      in combination with docetaxel and to select doses for further evaluation (Part 1, safety
      run-in portion).
Sponsor decision to not initiate part 2 of the trial and Part 2 of the study was not
      conducted.

      In Part 2, the randomized portion, the objective is to evaluate and compare the overall
      survival of subjects with previously treated advanced or metastatic non-small cell lung
      cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel
      alone.

      The secondary objectives of this study (Part 2) are to evaluate and compare the efficacy of
      the 2 treatment groups with respect to progression-free survival, overall tumor response, and
      duration of response, and to evaluate and compare disease control, safety, and tolerability
      of itacitinib in combination with docetaxel versus docetaxel alone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
time frame: Baseline through 21 days; the end of cycle 1.
description: Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).
arm group label: Itacitinib plus docetaxel
arm group type: Experimental
intervention type: Drug
intervention name: Itacitinib
description: Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
arm group label: Itacitinib plus docetaxel
other name: INCB039110
intervention type: Drug
intervention name: docetaxel
description: Administered as an intravenous infusion in the clinic at 75 mg/m^2 Q3W for Part 1 of the study.
arm group label: Itacitinib plus docetaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amit Pande, M.D.
role: Study Director
affiliation: Incyte Corporation
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country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel