<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/NCT01685255</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 24360-210</org_study_id>
    <nct_id>NCT01685255</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study of the IDO Inhibitor Epacadostat Versus Tamoxifen for Subjects With Biochemical-recurrent-only EOC, PPC or FTC Following Complete Remission With First-line Chemotherapy</brief_title>
  <official_title>A Randomized, Open-Label, Phase 2 Study of the IDO Inhibitor Epacadostat Versus Tamoxifen for Subjects With Biochemical-Recurrent-Only Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, or Fallopian Tube Cancer Following Complete Remission With First-Line Chemotherapy</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360&#xD;
      (epacadostat) versus tamoxifen in biochemical recurrent only ovarian cancer patients&#xD;
      following complete remission with first-line chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated by the sponsor for lack of evidence of superiority and slow study accrual.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 23, 2014</completion_date>
  <primary_completion_date type="Actual">October 23, 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 definition of progression as determined by the investigator.</measure>
    <time_frame>PFS is defined as the number of days from randomization to the earlier of death or disease progression for up to 36 months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability of epacadostat by adverse event assessment.</measure>
    <time_frame>Adverse events assessed every 2 weeks during cycle 1, then every 28 days thereafter until each subject's death or disease progression or for up to 36 months, whichever is longest.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Antigen (CA) 125 response rate, using Gynaecologic Cancer Intergroup (GCIG) criteria.</measure>
    <time_frame>CA 125 response rate defined as at least 50% reduction on study as compared to pretreatment sample; pre-treatment sample must be at least 2x ULN and response must be sustained for at least 28 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of overall survival.</measure>
    <time_frame>Overall survival followed every 12 weeks until last date known to be alive, until subjects withdraw consent or up to 36 months, whichever is longest.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival using RECIST 1.1 definition of objective progression as determined by the central imaging laboratory.</measure>
    <time_frame>Progression free survival defined by central imaging lab using RECIST 1.1 assessed at 8 week intervals, retrospectively, until disease progression, death, subject withdraw of consent or up to 36 months, whichever is longest.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Genitourinary (GU) Tumors</condition>
  <arm_group>
    <arm_group_label>Epacadostat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to Arm A (epacadostat) will take epacadostat tablets at a dose of 600 mg BID, beginning on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tamoxifen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epacadostat</intervention_name>
    <arm_group_label>Epacadostat</arm_group_label>
    <other_name>INCB024360</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tamoxifen</intervention_name>
    <arm_group_label>Tamoxifen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who have received first-line chemotherapy, which must have been a&#xD;
             platinum-containing regimen.&#xD;
&#xD;
          -  Subjects who received maintenance paclitaxel or, bevacizumab, or alternative&#xD;
             maintenance therapy (e.g. vaccines) are eligible for enrollment provided they have&#xD;
             discontinued therapy at least 4 weeks for prior taxane and, at least 8 weeks for&#xD;
             bevacizumab, or received medical monitor approval for time lapse from alternative&#xD;
             maintenance therapy prior to randomization and recovered from toxicities to less than&#xD;
             Grade 2.&#xD;
&#xD;
          -  Subject must be currently in remission by clinical and radiological criteria (Response&#xD;
             Evaluation Criteria for Solid Tumors [RECIST 1.1]).&#xD;
&#xD;
             a. If a PET scan or high-resolution CT scan is performed and demonstrates new disease&#xD;
             &lt;/= 1 cm, these subjects would be eligible.&#xD;
&#xD;
          -  Clinical remission is defined as: asymptomatic and a negative physical examination.&#xD;
&#xD;
          -  Scans are required post completion of platinum-containing therapy to document disease&#xD;
             remission.&#xD;
&#xD;
          -  Prior to the first-line regimen, CA 125 must have been elevated at first diagnosis,&#xD;
             must have normalized with the first-line therapy/regimen, and is currently elevated:&#xD;
&#xD;
             a. CA 125 elevation is defined as 2 consecutive measurements that are both above the&#xD;
             Upper Limit of Normal (ULN) at least 42 weeks apart, with the second measure showing&#xD;
             further increases from the first measurement&#xD;
&#xD;
               1. If CA 125 is ≥ 2 × ULN the confirmatory value only needs to be 1 week apart.&#xD;
&#xD;
               2. CA 125 elevation is defined as a value that is at least 2 × ULN on 2 occasions at&#xD;
                  least 1 week apart (UK ONLY REQUIREMENT).&#xD;
&#xD;
          -  CA 125 elevation must be at least 3 months from completion of first-line&#xD;
             platinum-containing regimen.&#xD;
&#xD;
          -  Documentation of at least 1 normal CA 125 level at approximately 3 months during or&#xD;
             following first line therapy is required.&#xD;
&#xD;
          -  Subjects must have available archived tumor tissue.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          -  Adequate renal, hepatic, and bone marrow function based on screening laboratory&#xD;
             assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any evidence of new disease (&gt; 1 cm) including new ascites as confirmed&#xD;
             by imaging.&#xD;
&#xD;
          -  Any other prior antitumor systemic therapy except for first-line chemotherapy&#xD;
             associated with previous CA 125 normalization or maintenance paclitaxel, bevacizumab,&#xD;
             or alternative maintenance therapy as approved by the medical monitor.&#xD;
&#xD;
          -  Subjects with prior radiotherapy within 3 months of randomization and have not&#xD;
             recovered from all radiotherapy-related toxicities, who have received radiation&#xD;
             therapy to the chest within 3 months of randomization, or who have a history or&#xD;
             radiation pneumonitis.&#xD;
&#xD;
          -  Subjects with protocol-specified active autoimmune processes except vitiligo or&#xD;
             thyroiditis.&#xD;
&#xD;
          -  Subjects receiving investigational study drug for any indication, immunological-based&#xD;
             treatment for any reason (except completed adjuvant therapy with medical monitor&#xD;
             approval), or potent CYP3A4 inducers or inhibitors.&#xD;
&#xD;
          -  Subjects receiving monoamine oxidase inhibitors (MAOIs) within the 21 days prior to&#xD;
             screening; subjects who have ever had Serotonin Syndrome (SS) after receiving 1 or&#xD;
             more serotonergic drugs.&#xD;
&#xD;
          -  Subjects for whom tamoxifen therapy is contraindicated.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lance Leopold, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</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>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</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>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bridgewater</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bendigo</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Heidelberg</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Herston</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milton</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Randwick</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Izhevsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krasnodar</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kursk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orenburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ufa</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chernivtsi</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dnepropetrovsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lutsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bebington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Keighley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Midlands</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <disposition_first_submitted>November 4, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>November 4, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 1, 2015</disposition_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FIGO Stage III or IV EOC</keyword>
  <keyword>PPC FTC</keyword>
  <keyword>increasing CA 125</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamoxifen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01685255
org study id: INCB 24360-210
nct id: NCT01685255
lead sponsor: 
has dmc: Yes
This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360
      (epacadostat) versus tamoxifen in biochemical recurrent only ovarian cancer patients
      following complete remission with first-line chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 definition of progression as determined by the investigator.
time frame: PFS is defined as the number of days from randomization to the earlier of death or disease progression for up to 36 months.
measure: Safety and tolerability of epacadostat by adverse event assessment.
time frame: Adverse events assessed every 2 weeks during cycle 1, then every 28 days thereafter until each subject's death or disease progression or for up to 36 months, whichever is longest.
measure: Cancer Antigen (CA) 125 response rate, using Gynaecologic Cancer Intergroup (GCIG) criteria.
time frame: CA 125 response rate defined as at least 50% reduction on study as compared to pretreatment sample; pre-treatment sample must be at least 2x ULN and response must be sustained for at least 28 days.
measure: Duration of overall survival.
time frame: Overall survival followed every 12 weeks until last date known to be alive, until subjects withdraw consent or up to 36 months, whichever is longest.
measure: Progression-free survival using RECIST 1.1 definition of objective progression as determined by the central imaging laboratory.
time frame: Progression free survival defined by central imaging lab using RECIST 1.1 assessed at 8 week intervals, retrospectively, until disease progression, death, subject withdraw of consent or up to 36 months, whichever is longest.
arm group label: Epacadostat
arm group type: Active Comparator
description: Subjects randomized to Arm A (epacadostat) will take epacadostat tablets at a dose of 600 mg BID, beginning on Day 1.
arm group label: Tamoxifen
arm group type: Active Comparator
description: Subjects randomized to Arm B (tamoxifen) will take tamoxifen tablets at a dose of 20 mg BID, beginning on Day 1.
intervention type: Drug
intervention name: Epacadostat
arm group label: Epacadostat
other name: INCB024360
intervention type: Drug
intervention name: tamoxifen
arm group label: Tamoxifen
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lance Leopold, M.D.
role: Study Director
affiliation: Incyte Corporation
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country: Australia
country: Canada
country: Russian Federation
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Tamoxifen
sharing ipd: Undecided