<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/NCT04455841</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 00928-104</org_study_id>
    <nct_id>NCT04455841</nct_id>
  </id_info>
  <brief_title>INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders</brief_title>
  <official_title>A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and&#xD;
      tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in&#xD;
      combination with ruxolitinib in participants with MF who are transfusion-dependent or&#xD;
      presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and&#xD;
      expansion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 19, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Number of treatment-related adverse events</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>To determine the safety and tolerability of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anemia Response</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Defined as an increase in hemoglobin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Anemia Response</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Duration of anemia response at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change of Hemoglobin</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Mean change in hemoglobin levels from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of RBC transfusion</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Defined as the average number of RBC units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TGB only -Splenic Volume</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Defined as the proportion of participants achieving a targeted reduction in spleen volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TGB Only - Splenic Length</measure>
    <time_frame>Approximately Up to 13 months</time_frame>
    <description>Defined as the proportion of participants achieving a targeted reduction in spleen length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TGB only - Objective Response Rate</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>defined as the proportion of participants with Complete Response or Partial Response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TGB only - Progression Free Survival</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Defined as the interval from the first dose of study treatment until the first documented progression or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TGB only - Leukemia Free Survival</measure>
    <time_frame>Approximately upto 13 months</time_frame>
    <description>defined as the interval from the first dose of study treatment until the first documented leukemia transformation or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Area Under the Plasma Concentration versus Time curve of INCB 00928-104</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Time to reach maximum (peak) plasma concentration of INCB 00928-104</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-t</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepcidin levels</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Effect of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB) on hepcidin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron Homeostasis</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Effect of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB) on iron homeostasis parameters such as TSI, ferritin, transferrin, TSAT, TIBC, UIBC, and serum NTBI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythropoesis</measure>
    <time_frame>Approximately up to 13 months</time_frame>
    <description>Effect of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB) on erythropoiesis parameters such as RC, NRBC, MCV, MCH, Hgb, Hct, RBC count, MCHC, and RDW.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anemia</condition>
  <condition>Post-essential Thrombocythemia Myelofibrosis</condition>
  <condition>Post-polycythemia Vera Myelofibrosis</condition>
  <arm_group>
    <arm_group_label>Treatment Group A (TGA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INCB000928 will be administered once daily( QD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group B (TGB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INCB000928 will be administered in combination with ruxolitinib.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INCB000928</intervention_name>
    <description>INCB000928 Dose Escalation</description>
    <arm_group_label>Treatment Group A (TGA)</arm_group_label>
    <arm_group_label>Treatment Group B (TGB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ruxolitinib</intervention_name>
    <description>INCB000928 +ruxolitinib Dose Expansion</description>
    <arm_group_label>Treatment Group B (TGB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with MF who are transfusion-dependent or present with symptomatic anemia,&#xD;
             defined as follows:&#xD;
&#xD;
               1. Anemia: An Hgb value &lt; 10 g/dL demonstrated during screening recorded on 3&#xD;
                  separate occasions with at least 7 days between measurements (Note: RBC&#xD;
                  transfusion must be at least 2 weeks before the Hgb measurement during&#xD;
                  screening).&#xD;
&#xD;
               2. Transfusion-dependent: Participant has received at least 4 units of RBC&#xD;
                  transfusions during the 28 days immediately preceding Cycle 1 Day 1 OR has&#xD;
                  received an average of at least 4 units of RBC transfusions in the 8 weeks&#xD;
                  immediately preceding Cycle 1 Day 1, for an Hgb level of &lt; 8.5 g/dL, in the&#xD;
                  absence of bleeding or treatment-induced anemia. In addition, the most recent&#xD;
                  transfusion episode must have occurred in the 28 days before Cycle 1 Day 1.&#xD;
&#xD;
          -  ECOG performance status score of the following:&#xD;
&#xD;
               1. 0 or 1 for the dose-escalation stages.&#xD;
&#xD;
               2. 0, 1, or 2 for the dose-expansion stage.&#xD;
&#xD;
          -  Life expectancy is greater than 6 months&#xD;
&#xD;
          -  Agreement to avoid pregnancy or fathering children.&#xD;
&#xD;
          -  Ineligible to receive or have not responded to available therapies for anemia such as&#xD;
             ESAs.&#xD;
&#xD;
          -  For TGA:&#xD;
&#xD;
          -  Participants previously treated with JAK inhibitors for at least 12 weeks.&#xD;
&#xD;
          -  Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria.&#xD;
&#xD;
          -  For TGB:&#xD;
&#xD;
          -  Participants must have been on a therapeutic and stable regimen of ruxolitinib for at&#xD;
             least 12 consecutive weeks immediately preceding the first dose of study treatment.&#xD;
&#xD;
          -  Participants with intermediate-1, intermediate-2, or high DIPSS MF according to&#xD;
             IWG-MRT criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undergone any prior allogenic or autologous stem cell transplantation or a candidate&#xD;
             for such transplantation.&#xD;
&#xD;
          -  Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,&#xD;
             biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating&#xD;
             agent to treat the participant's disease, with the exception of ruxolitinib for TGB&#xD;
             only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of&#xD;
             study treatment.&#xD;
&#xD;
          -  Laboratory Values outside of protocol defined range at screening.&#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>Ekatarine Asantiani, MD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Incyte Corporation Call Center (US)</last_name>
    <phone>1.855.463.3463</phone>
    <email>medinfo@incyte.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Incyte Corporation Call Center (ex-US)</last_name>
    <phone>1.855.463.3463</phone>
    <email>globalmedinfo@incyte.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>City of Hope Orange County</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Usc Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory University - Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory University-Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Start Midwest</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical Centers</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </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>
    <status>Recruiting</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>MG5 2R2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier D'Angers</name>
      <address>
        <city>Angers Cedex 01</city>
        <zip>49033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille Cedex 9</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Papa Giovanni Xxiii</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>S Orsolas University Hospital Seragnoli Institute of Hematology</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi (Aouc)</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano</name>
      <address>
        <city>Orbassano</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria Della Misericordia Perugia</name>
      <address>
        <city>Perugia</city>
        <zip>06124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical and Dental University Hospital</name>
      <address>
        <city>Bunkyo-ku</city>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba</city>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gifu Municipal Hospital</name>
      <address>
        <city>Gifu</city>
        <zip>500-8513</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata</city>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kumamoto Shinto General Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>862-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka-shi</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>United Lincolnshire Hospitals</name>
      <address>
        <city>Boston</city>
        <zip>PE21 9QS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital Truro Sunrise Centre</name>
      <address>
        <city>Truro</city>
        <zip>TR1 3LQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Genesiscare Center</name>
      <address>
        <city>Windsor</city>
        <zip>SL4 3HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.incyteclinicaltrials.com/limber/</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</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>Polycythemia Vera</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Primary Myelofibrosis</mesh_term>
    <mesh_term>Polycythemia</mesh_term>
    <mesh_term>Thrombocytosis</mesh_term>
    <mesh_term>Thrombocythemia, Essential</mesh_term>
    <mesh_term>Myeloproliferative Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.</ipd_time_frame>
    <ipd_access_criteria>Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://www.incyte.com/our-company/compliance-and-transparency</ipd_url>
  </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/NCT04455841
org study id: INCB 00928-104
nct id: NCT04455841
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and
      tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in
      combination with ruxolitinib in participants with MF who are transfusion-dependent or
      presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and
      expansion.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of treatment-related adverse events
time frame: Approximately up to 13 months
description: To determine the safety and tolerability of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB).
measure: Anemia Response
time frame: Approximately up to 13 months
description: Defined as an increase in hemoglobin.
measure: Duration of Anemia Response
time frame: Approximately up to 13 months
description: Duration of anemia response at baseline.
measure: Mean Change of Hemoglobin
time frame: Approximately up to 13 months
description: Mean change in hemoglobin levels from baseline
measure: Rate of RBC transfusion
time frame: Approximately up to 13 months
description: Defined as the average number of RBC units
measure: TGB only -Splenic Volume
time frame: Approximately up to 13 months
description: Defined as the proportion of participants achieving a targeted reduction in spleen volume
measure: TGB Only - Splenic Length
time frame: Approximately Up to 13 months
description: Defined as the proportion of participants achieving a targeted reduction in spleen length
measure: TGB only - Objective Response Rate
time frame: Approximately up to 13 months
description: defined as the proportion of participants with Complete Response or Partial Response
measure: TGB only - Progression Free Survival
time frame: Approximately up to 13 months
description: Defined as the interval from the first dose of study treatment until the first documented progression or death
measure: TGB only - Leukemia Free Survival
time frame: Approximately upto 13 months
description: defined as the interval from the first dose of study treatment until the first documented leukemia transformation or death from any cause
measure: AUC
time frame: Approximately up to 13 months
description: Area Under the Plasma Concentration versus Time curve of INCB 00928-104
measure: Tmax
time frame: Approximately up to 13 months
description: Time to reach maximum (peak) plasma concentration of INCB 00928-104
measure: AUC0-t
time frame: Approximately up to 13 months
description: Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
measure: Hepcidin levels
time frame: Approximately up to 13 months
description: Effect of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB) on hepcidin levels
measure: Iron Homeostasis
time frame: Approximately up to 13 months
description: Effect of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB) on iron homeostasis parameters such as TSI, ferritin, transferrin, TSAT, TIBC, UIBC, and serum NTBI.
measure: Erythropoesis
time frame: Approximately up to 13 months
description: Effect of INCB000928 administered as monotherapy (TGA) or in combination with ruxolitinib (TGB) on erythropoiesis parameters such as RC, NRBC, MCV, MCH, Hgb, Hct, RBC count, MCHC, and RDW.
arm group label: Treatment Group A (TGA)
arm group type: Experimental
description: INCB000928 will be administered once daily( QD).
arm group label: Treatment Group B (TGB)
arm group type: Experimental
description: INCB000928 will be administered in combination with ruxolitinib.
intervention type: Drug
intervention name: INCB000928
description: INCB000928 Dose Escalation
arm group label: Treatment Group A (TGA)
arm group label: Treatment Group B (TGB)
intervention type: Drug
intervention name: ruxolitinib
description: INCB000928 +ruxolitinib Dose Expansion
arm group label: Treatment Group B (TGB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ekatarine Asantiani, MD
role: Study Director
affiliation: Incyte Corporation
last name: Incyte Corporation Call Center (US)
phone: 1.855.463.3463
email: medinfo@incyte.com
last name: Incyte Corporation Call Center (ex-US)
phone: 1.855.463.3463
email: globalmedinfo@incyte.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Completed
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
country: Canada
country: France
country: Italy
country: Japan
country: United Kingdom
country: United States
url: https://www.incyteclinicaltrials.com/limber/
description: Related Info
responsible party type: Sponsor
mesh term: Polycythemia Vera
mesh term: Anemia
mesh term: Primary Myelofibrosis
mesh term: Polycythemia
mesh term: Thrombocytosis
mesh term: Thrombocythemia, Essential
mesh term: Myeloproliferative Disorders
sharing ipd: Yes
ipd description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
ipd access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
ipd url: https://www.incyte.com/our-company/compliance-and-transparency