<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/NCT03042013</url>
  </required_header>
  <id_info>
    <org_study_id>8273-CL-0201</org_study_id>
    <secondary_id>2016-003183-39</secondary_id>
    <nct_id>NCT03042013</nct_id>
  </id_info>
  <brief_title>A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study</brief_title>
  <official_title>An Open-label, Multicenter, Rollover Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma 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 the study is to evaluate long-term safety and tolerability of continuous&#xD;
      treatment with ASP8273 in subjects who are participating in an Astellas-sponsored ASP8273&#xD;
      study which has completed, at a minimum, the primary analysis or have completed the&#xD;
      individual study evaluation period and for whom the investigator feels the subject may have&#xD;
      potential to continue to derive clinical benefit from treatment with ASP8273.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, rollover study for subjects with non-small cell lung cancer (NSCLC)&#xD;
      with an epidermal growth factor receptor (EGFR) activating mutation who are currently&#xD;
      participating in studies evaluating ASP8273.&#xD;
&#xD;
      Subjects should sign the informed consent at cycle 1 day 1 visit. The assessments from the&#xD;
      last treatment visit from the parent study can be utilized for the cycle 1 day 1 visit.&#xD;
      Either local or central laboratories may be utilized for the cycle 1 day 1 visit if&#xD;
      assessments are used from the last treatment visit of the parent study. The subject will then&#xD;
      receive ASP8273 study drug for the rollover study and return all ASP8273 study drug from the&#xD;
      parent study. Subjects will continue on to subsequent 28-day cycles until 1 of the&#xD;
      discontinuation criteria are met. Upon enrollment, subjects with fewer than 6 cycles of study&#xD;
      drug dosing in the parent study will return to the clinic on day 1 of each cycle up to cycle&#xD;
      5. After cycle 5, these subjects can switch to day 1 of every other odd cycle for clinic&#xD;
      visits. Subjects with 6 or more cycles of study drug dosing upon enrollment into the rollover&#xD;
      study will return to the clinic on day 1 of every other odd cycle (e.g., cycles 3, 5, etc.).&#xD;
      Imaging methods and frequency will be performed per standard of care.&#xD;
&#xD;
      An end of treatment study visit will be conducted 30 days after the last dose of study&#xD;
      medication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.&#xD;
  </why_stopped>
  <start_date type="Actual">February 28, 2017</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Incidence of adverse events (safety and tolerability)</measure>
    <time_frame>Up to a maximum of 1 month (per cycle)</time_frame>
    <description>An Adverse Event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with laboratory value abnormalities and/or adverse events related to treatment</measure>
    <time_frame>Up to a maximum of 1 month (per cycle)</time_frame>
    <description>Number of participants with potentially clinically significant laboratory values</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Subjects With NSCLC With an EGFR Activating Mutation</condition>
  <arm_group>
    <arm_group_label>ASP8273</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a once or twice daily oral dose of ASP8273 (3 dose strengths)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP8273</intervention_name>
    <description>Oral</description>
    <arm_group_label>ASP8273</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be participating in an Astellas-sponsored ASP8273 study which has&#xD;
             completed, at a minimum, the primary analysis or have completed the individual study&#xD;
             evaluation period requirements. Subject must not have met any discontinuation criteria&#xD;
             in the parent study.&#xD;
&#xD;
          -  Subject must be receiving a stable dose of ASP8273 for 14 days minimum and is able to&#xD;
             enroll into this rollover study without treatment interruption of study drug, or with&#xD;
             no more than 21 consecutive days of treatment interruption in study drug within the&#xD;
             parent study.&#xD;
&#xD;
          -  Subject should be deriving clinical benefit without any persistent intolerable&#xD;
             toxicity from continued treatment of ASP8273.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study while on treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who developed persistent intolerable toxicity to ASP8273 treatment in the&#xD;
             parent study.&#xD;
&#xD;
          -  Subject who received any other systemic anticancer treatment after parent study entry&#xD;
             (radiation to local areas such as bone or brain if received in the parent ASP8273&#xD;
             study is permitted).&#xD;
&#xD;
          -  Subject who requires the following medications will be excluded:&#xD;
&#xD;
               -  Chemotherapy, radiotherapy, immunotherapy or other medications intended for&#xD;
                  antitumor activity&#xD;
&#xD;
               -  Investigational products or therapy other than ASP8273&#xD;
&#xD;
               -  Strong inhibitors or inducers of CYP3A4&#xD;
&#xD;
               -  Permeability-glycoprotein (P-gp) substrates with a narrow therapeutic index&#xD;
&#xD;
          -  Subject has any condition which may require treatment during the study and may make&#xD;
             the subject unsuitable for study participation.&#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>Senior Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>July 7, 2017</last_update_submitted>
  <last_update_submitted_qc>July 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASP8273</keyword>
  <keyword>Non-Small-Cell Lung Cancer</keyword>
  <keyword>EGFR mutations</keyword>
  <keyword>Oncology</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naquotinib</mesh_term>
  </intervention_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/NCT03042013
org study id: 8273-CL-0201
secondary id: 2016-003183-39
nct id: NCT03042013
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to evaluate long-term safety and tolerability of continuous
      treatment with ASP8273 in subjects who are participating in an Astellas-sponsored ASP8273
      study which has completed, at a minimum, the primary analysis or have completed the
      individual study evaluation period and for whom the investigator feels the subject may have
      potential to continue to derive clinical benefit from treatment with ASP8273.
This is a multicenter, rollover study for subjects with non-small cell lung cancer (NSCLC)
      with an epidermal growth factor receptor (EGFR) activating mutation who are currently
      participating in studies evaluating ASP8273.

      Subjects should sign the informed consent at cycle 1 day 1 visit. The assessments from the
      last treatment visit from the parent study can be utilized for the cycle 1 day 1 visit.
      Either local or central laboratories may be utilized for the cycle 1 day 1 visit if
      assessments are used from the last treatment visit of the parent study. The subject will then
      receive ASP8273 study drug for the rollover study and return all ASP8273 study drug from the
      parent study. Subjects will continue on to subsequent 28-day cycles until 1 of the
      discontinuation criteria are met. Upon enrollment, subjects with fewer than 6 cycles of study
      drug dosing in the parent study will return to the clinic on day 1 of each cycle up to cycle
      5. After cycle 5, these subjects can switch to day 1 of every other odd cycle for clinic
      visits. Subjects with 6 or more cycles of study drug dosing upon enrollment into the rollover
      study will return to the clinic on day 1 of every other odd cycle (e.g., cycles 3, 5, etc.).
      Imaging methods and frequency will be performed per standard of care.

      An end of treatment study visit will be conducted 30 days after the last dose of study
      medication.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events (safety and tolerability)
time frame: Up to a maximum of 1 month (per cycle)
description: An Adverse Event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product
measure: Number of participants with laboratory value abnormalities and/or adverse events related to treatment
time frame: Up to a maximum of 1 month (per cycle)
description: Number of participants with potentially clinically significant laboratory values
arm group label: ASP8273
arm group type: Experimental
description: Subjects will receive a once or twice daily oral dose of ASP8273 (3 dose strengths)
intervention type: Drug
intervention name: ASP8273
description: Oral
arm group label: ASP8273
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Senior Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
country: United States
responsible party type: Sponsor
mesh term: Naquotinib
sharing ipd: Undecided