<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/NCT03235570</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 54828-102</org_study_id>
    <nct_id>NCT03235570</nct_id>
  </id_info>
  <brief_title>A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)</brief_title>
  <official_title>A Phase 1, Open-Label, Dose-Escalation, Dose-Expansion, Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and tolerability of pemigatinib in&#xD;
      Japanese subjects with advanced malignancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2020</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>Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)</measure>
    <time_frame>Baseline through 30 days after end of treatment, up to approximately 16 months.</time_frame>
    <description>An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</measure>
    <time_frame>Baseline and Day 15 of every third treatment cycle, up to approximately 6 months</time_frame>
    <description>Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level</measure>
    <time_frame>Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months</time_frame>
    <description>Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Plasma Concentration of pemigatinib</measure>
    <time_frame>During the first cycle, up to Day 16</time_frame>
    <description>PK parameters will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental (model independent) PK methods.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Pemigatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 1 is an open-label dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemigatinib</intervention_name>
    <description>Pemigatinib at the protocol-defined dose administered once daily.</description>
    <arm_group_label>Pemigatinib</arm_group_label>
    <other_name>INCB054828</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First generation Japanese; subject was born in Japan and has not lived outside of&#xD;
             Japan for a total of &gt; 10 years and subject can trace maternal and paternal Japanese&#xD;
             ancestry.&#xD;
&#xD;
          -  Part 1: Any histologically confirmed advanced solid tumor malignancy. Subjects&#xD;
             enrolled at a lower dose level expansion cohort are required to have documented&#xD;
             FGF/FGFR alterations and baseline and on-treatment tumor biopsy for testing of&#xD;
             biomarkers.&#xD;
&#xD;
          -  Part 2: Any histologically confirmed advanced solid tumor malignancy with a FGF/FGFR&#xD;
             alteration&#xD;
&#xD;
          -  Advanced or metastatic and recurrent cancer where an appropriate treatment option is&#xD;
             not available.&#xD;
&#xD;
          -  Life expectancy &gt; 12 weeks.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status: Part 1: 0 or 1; Part 2:&#xD;
             0, 1, or 2.&#xD;
&#xD;
          -  Genomic testing is mandatory for all enrolled subjects. Archival tumor specimen of at&#xD;
             least 7 slides or willingness to undergo a pretreatment tumor biopsy to provide a&#xD;
             tumor block or at least 7 unstained slides. Archival tumor biopsies are acceptable at&#xD;
             baseline and should be no more than 2 years old (preferably less than 1 year old and&#xD;
             collected since the completion of the last treatment); subjects with samples older&#xD;
             than 2 years old and/or with sequencing report from the central laboratory require&#xD;
             approval from the sponsor medical monitor for exemption from tumor biopsy or tumor&#xD;
             sample requirement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with other investigational study drug for any indication for any reason, or&#xD;
             receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer)&#xD;
             before first dose of study drug (6 weeks for mitomycin-C or nitrosoureas, 7 days for&#xD;
             tyrosine kinase inhibitors).&#xD;
&#xD;
          -  Prior receipt of a selective FGFR inhibitor.&#xD;
&#xD;
          -  Laboratory and medical history parameters outside Protocol-defined range.&#xD;
&#xD;
          -  History and/or current evidence of ectopic mineralization/calcification including but&#xD;
             not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting&#xD;
             calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification.&#xD;
&#xD;
          -  Current evidence of corneal disorder/keratopathy including but not limited to&#xD;
             bullous/band keratopathy, corneal abrasion, inflammation/ulceration,&#xD;
             keratoconjunctivitis, confirmed by ophthalmologic examination.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ekaterine Asatiani, MD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Aichi</city>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba</city>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Central Hospital East</name>
      <address>
        <city>Chiba</city>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyusyu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Ishikawa</city>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Kanagawa</city>
        <zip>241-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Saitama</city>
        <zip>362-0806</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Cancer Center</name>
      <address>
        <city>Sapporo</city>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Central Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JFCR Ariake Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Solid tumor</keyword>
  <keyword>malignancy</keyword>
  <keyword>fibroblast growth factor receptor (FGFR)</keyword>
  <keyword>fibroblast growth factor (FGF)/FGFR alteration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03235570
org study id: INCB 54828-102
nct id: NCT03235570
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in
      Japanese subjects with advanced malignancies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
time frame: Baseline through 30 days after end of treatment, up to approximately 16 months.
description: An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
measure: Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
time frame: Baseline and Day 15 of every third treatment cycle, up to approximately 6 months
description: Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type.
measure: Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level
time frame: Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months
description: Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment.
measure: Observed Plasma Concentration of pemigatinib
time frame: During the first cycle, up to Day 16
description: PK parameters will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental (model independent) PK methods.
arm group label: Pemigatinib
arm group type: Experimental
description: Part 1 is an open-label dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1.
intervention type: Drug
intervention name: Pemigatinib
description: Pemigatinib at the protocol-defined dose administered once daily.
arm group label: Pemigatinib
other name: INCB054828
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ekaterine Asatiani, MD
role: Study Director
affiliation: Incyte Corporation
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: Japan
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No