<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/NCT02979821</url>
  </required_header>
  <id_info>
    <org_study_id>PZT1401</org_study_id>
    <nct_id>NCT02979821</nct_id>
  </id_info>
  <brief_title>Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)</brief_title>
  <official_title>A Phase II Study to Assess Efficacy of Pan-HER Inhibitor (HM781-36B, Poziotinib) in Stage IV Lung Adenocarcinoma With HER2 Mutation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korean Association for the Study of Targeted Therapy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kosin University Gospel Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chungnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Korean Association for the Study of Targeted Therapy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with&#xD;
      stage IV lung adenocarcinoma harboring HER2 mutation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to be multi-center, open-label, single-arm, prospective, phase II&#xD;
      trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received&#xD;
      prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study&#xD;
      duration is 36 months from IRB and Korea: MFDS approval date.&#xD;
&#xD;
      The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until&#xD;
      disease progression or manifestation of unacceptable toxicity. The initial dose of the study&#xD;
      drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in&#xD;
      protocol. A cycle of study treatment is defined as 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Objective Response Rate; ORR including rage of CR&amp;PR</measure>
    <time_frame>through study completion (3 years)</time_frame>
    <description>It will be assessed on based of RECIST 1.1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to progression, TTP</measure>
    <time_frame>through study completion (3 years)</time_frame>
    <description>from first IP administration to date of first documented progression</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>HER2 Gene Mutation</condition>
  <condition>Adenocarcinoma Lung Stage IV</condition>
  <arm_group>
    <arm_group_label>Poziotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Poziotinib</intervention_name>
    <description>A cycle of study treatment is defined as 28 days.</description>
    <arm_group_label>Poziotinib</arm_group_label>
    <other_name>NOV120101</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. lung adenocarcinoma, stage IV&#xD;
&#xD;
          2. Patients with HER2 mutation by sequencing&#xD;
&#xD;
             - Confirmed triple-negative patients with remnant tumor DNA&#xD;
&#xD;
          3. Patients who have histories of previous exposure to at least one more systemic&#xD;
             chemotherapies (not EGFR-TKI)&#xD;
&#xD;
          4. ECOG performance status 0~2&#xD;
&#xD;
          5. Patient with at least one measurable lesions according to RECIST&#xD;
&#xD;
          6. Patients who have proper organ functions as follows&#xD;
&#xD;
               -  Neutrophil count: &gt; 1,500/uL&#xD;
&#xD;
               -  Platelet count: &gt; 100,000/uL&#xD;
&#xD;
               -  Hb: &gt; 9.0g/dL&#xD;
&#xD;
               -  AST/ALT : &lt; 2.0 x upper normal limit&#xD;
&#xD;
               -  Bilirubin: &lt; 1.25 x upper normal limit&#xD;
&#xD;
               -  Serum creatinine : &lt; upper normal limit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Expected lie expectancy &lt; 3 months&#xD;
&#xD;
          2. CNS metastasis or spinal cord compression which were not treated with operation and/or&#xD;
             radiation therapy(but, Patient with medically stable condition after operation and/or&#xD;
             radiation therapy, or without symptomatic metastasis of brain in accordance with the&#xD;
             investigator's judgment could participate in the study)&#xD;
&#xD;
          3. Patients who have severe or unstable systemic disease in accordance with the&#xD;
             investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or&#xD;
             renal disease)&#xD;
&#xD;
          4. Patients who have histories of previous exposure to EGFR-TKI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kye-Young, Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kunkok University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korean Association for the Study of Targeted Therapy</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pan-HER inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02979821
org study id: PZT1401
nct id: NCT02979821
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with
      stage IV lung adenocarcinoma harboring HER2 mutation.
This study is designed to be multi-center, open-label, single-arm, prospective, phase II
      trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received
      prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study
      duration is 36 months from IRB and Korea: MFDS approval date.

      The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until
      disease progression or manifestation of unacceptable toxicity. The initial dose of the study
      drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in
      protocol. A cycle of study treatment is defined as 28 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate; ORR including rage of CR&PR
time frame: through study completion (3 years)
description: It will be assessed on based of RECIST 1.1.
measure: Time to progression, TTP
time frame: through study completion (3 years)
description: from first IP administration to date of first documented progression
arm group label: Poziotinib
arm group type: Experimental
description: The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria.
intervention type: Drug
intervention name: Poziotinib
description: A cycle of study treatment is defined as 28 days.
arm group label: Poziotinib
other name: NOV120101
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kye-Young, Lee, MD, PhD
role: Principal Investigator
affiliation: Kunkok University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma of Lung
sharing ipd: Undecided