<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/NCT03804515</url>
  </required_header>
  <id_info>
    <org_study_id>SPI-POZ-102</org_study_id>
    <nct_id>NCT03804515</nct_id>
  </id_info>
  <brief_title>A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib</brief_title>
  <official_title>A Phase 1 Study for the Evaluation of Excretion (Mass Balance) and Pharmacokinetics of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spectrum Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spectrum Pharmaceuticals, Inc</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to determine routes of excretion and single-dose PK parameters&#xD;
      for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2&#xD;
      overexpression/amplification.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, open-label, single-dose study of 14C-labeled poziotinib to determine&#xD;
      routes of excretion and single-dose PK parameters for poziotinib in patients with solid&#xD;
      tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.&#xD;
&#xD;
      On Day 1, enrolled patients will be admitted to the inpatient unit and all predose&#xD;
      assessments will be completed. Patients will be admitted to the inpatient unit for 9 days. On&#xD;
      Day 2, a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110&#xD;
      μCi) will be administered orally in the morning right after breakfast with at least 200 mL of&#xD;
      water.&#xD;
&#xD;
      Over the following 168 hours, urine and feces will be collected and pooled at specified&#xD;
      intervals for measurement of total radioactivity recovered and subsequent determination of&#xD;
      the routes of elimination of poziotinib and its metabolites. Blood samples will be taken at&#xD;
      specified time points for 168 hours after dosing for estimation of single-dose poziotinib PK&#xD;
      parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID&#xD;
  </why_stopped>
  <start_date type="Actual">June 25, 2019</start_date>
  <completion_date type="Actual">June 17, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 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>Maximum recovery of the radioactive dose in plasma, urine and feces</measure>
    <time_frame>1 year</time_frame>
    <description>The route of excretion of radioactive poziotinib and its metabolites following single oral administration of 14C-labeled poziotinib in patients with solid tumors suitable for treatment with poziotinib.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The concentration of 14C-labeled poziotinib and its metabolites in plasma, urine and feces</measure>
    <time_frame>1 year</time_frame>
    <description>To identify major metabolites of poziotinib</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>14C-labeled Poziotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>14C-labeled poziotinib</intervention_name>
    <description>a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally</description>
    <arm_group_label>14C-labeled Poziotinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient can be male or female and is at least 18 years of age&#xD;
&#xD;
          -  Patient must be willing and capable of giving written Informed Consent and willing to&#xD;
             stay in the research unit for 9 days.&#xD;
&#xD;
          -  Patient has a life expectancy of at least 6 months.&#xD;
&#xD;
          -  Histological confirmation of solid tumor cancer that is suitable for poziotinib&#xD;
             therapy. These may include patients with any solid malignancy with either EGFR or HER&#xD;
             2 mutations or EGFR/HER2 overexpression/amplification. Brain metastases are allowed,&#xD;
             if patient is clinically stable and does not require treatment with anticonvulsants or&#xD;
             escalating steroid doses.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a diagnosis of primary and or metastatic hepatic or renal carcinomas.&#xD;
&#xD;
          -  Patient is unable to take oral medication or has ongoing Grade ≥2 diarrhea due to any&#xD;
             etiology including Crohn's disease and/or ulcerative colitis.&#xD;
&#xD;
          -  Previous poziotinib exposure&#xD;
&#xD;
          -  Patient has previously participated in a study utilizing 14C.&#xD;
&#xD;
          -  Patient has any pathology or history of procedures expected to change absorption&#xD;
&#xD;
          -  Patient has a PEG (Percutaneous Endoscopic Gastrostomy) tube&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>June 14, 2021</last_update_submitted>
  <last_update_submitted_qc>June 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EGFR</keyword>
  <keyword>HER2 mutations</keyword>
  <keyword>EGFR/HER2 overexpression/amplification</keyword>
  <!-- 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/NCT03804515
org study id: SPI-POZ-102
nct id: NCT03804515
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine routes of excretion and single-dose PK parameters
      for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2
      overexpression/amplification.
This is a Phase 1, open-label, single-dose study of 14C-labeled poziotinib to determine
      routes of excretion and single-dose PK parameters for poziotinib in patients with solid
      tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.

      On Day 1, enrolled patients will be admitted to the inpatient unit and all predose
      assessments will be completed. Patients will be admitted to the inpatient unit for 9 days. On
      Day 2, a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110
      μCi) will be administered orally in the morning right after breakfast with at least 200 mL of
      water.

      Over the following 168 hours, urine and feces will be collected and pooled at specified
      intervals for measurement of total radioactivity recovered and subsequent determination of
      the routes of elimination of poziotinib and its metabolites. Blood samples will be taken at
      specified time points for 168 hours after dosing for estimation of single-dose poziotinib PK
      parameters.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum recovery of the radioactive dose in plasma, urine and feces
time frame: 1 year
description: The route of excretion of radioactive poziotinib and its metabolites following single oral administration of 14C-labeled poziotinib in patients with solid tumors suitable for treatment with poziotinib.
measure: The concentration of 14C-labeled poziotinib and its metabolites in plasma, urine and feces
time frame: 1 year
description: To identify major metabolites of poziotinib
arm group label: 14C-labeled Poziotinib
arm group type: Experimental
intervention type: Drug
intervention name: 14C-labeled poziotinib
description: a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally
arm group label: 14C-labeled Poziotinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor