<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/NCT02228421</url>
  </required_header>
  <id_info>
    <org_study_id>PMPC-03</org_study_id>
    <nct_id>NCT02228421</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients</brief_title>
  <official_title>A Phase IV Multicenter Trial to Evaluate Real-world Pharmacoeconomics of Crizotinib and Its Companion Diagnostic Test in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PeriPharm</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Personalized Medicine Partnership for Cancer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PeriPharm</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of&#xD;
      crizotinib and its companion diagnostic test used in a real-life setting in advanced&#xD;
      ALK-positive non-small cell lung cancer (NSCLC) patients.&#xD;
&#xD;
      NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the&#xD;
      ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor&#xD;
      tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC,&#xD;
      the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of&#xD;
      activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK&#xD;
      rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with&#xD;
      adenocarcinoma histology, in never smokers and in those who are known to be wild type for&#xD;
      EGFR and KRAS.&#xD;
&#xD;
      Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+&#xD;
      NSCLC patients. This is an example of personalized medicine, where patients are selected for&#xD;
      treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for&#xD;
      their disease. The pharmacoeconomic impact of using genetic information in early treatment&#xD;
      decisions in NSCLC has not been determined.&#xD;
&#xD;
      The study will enable real-life Heath Economics and Outcome Research (HEOR).&#xD;
&#xD;
      Approximately 90 patients will be recruited. Patients will be asked to complete&#xD;
      quality-of-life questionnaires at regular intervals in a real-life setting of treatment with&#xD;
      crizotinib.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The pharmacoeconomic impact of using personalized medicine for the treatment of ALK+ lung cancer.</measure>
    <time_frame>From the date of registration until date of death from any cause, assessed up to 60 months.</time_frame>
    <description>Pharmacoeconomic impact (cost-effectiveness and cost utility) will be evaluated by questionnaires completed by the patient and caregiver. These include quality of life, health resource utilization, work productivity and activity impairment, and health questionnaires.</description>
  </primary_outcome>
  <enrollment type="Actual">29</enrollment>
  <condition>Non-small Cell Lung Cancer Metastatic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) found&#xD;
        positive for ALK mutation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed locally advanced or metastatic NSCLC&#xD;
&#xD;
          -  Presence of the ALK-fusion oncogene (ALK+) as determined using a validated testing&#xD;
             platform&#xD;
&#xD;
          -  Planned first or second-line treatment with crizotinib&#xD;
&#xD;
          -  Signed and dated IRB-approved informed consent document&#xD;
&#xD;
          -  Ability to read and understand English or French&#xD;
&#xD;
          -  18 years of age or older&#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>Jason Agulnik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jewish General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Victor Cohen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jewish General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSSS de Rimouski-Neigette</name>
      <address>
        <city>Rimouski</city>
        <state>Quebec</state>
        <zip>J5L 5T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <!-- 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/NCT02228421
org study id: PMPC-03
nct id: NCT02228421
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of
      crizotinib and its companion diagnostic test used in a real-life setting in advanced
      ALK-positive non-small cell lung cancer (NSCLC) patients.

      NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the
      ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor
      tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC,
      the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of
      activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK
      rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with
      adenocarcinoma histology, in never smokers and in those who are known to be wild type for
      EGFR and KRAS.

      Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+
      NSCLC patients. This is an example of personalized medicine, where patients are selected for
      treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for
      their disease. The pharmacoeconomic impact of using genetic information in early treatment
      decisions in NSCLC has not been determined.

      The study will enable real-life Heath Economics and Outcome Research (HEOR).

      Approximately 90 patients will be recruited. Patients will be asked to complete
      quality-of-life questionnaires at regular intervals in a real-life setting of treatment with
      crizotinib.
observational model: Cohort
time perspective: Prospective
measure: The pharmacoeconomic impact of using personalized medicine for the treatment of ALK+ lung cancer.
time frame: From the date of registration until date of death from any cause, assessed up to 60 months.
description: Pharmacoeconomic impact (cost-effectiveness and cost utility) will be evaluated by questionnaires completed by the patient and caregiver. These include quality of life, health resource utilization, work productivity and activity impairment, and health questionnaires.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Agulnik, MD
role: Principal Investigator
affiliation: Jewish General Hospital
last name: Victor Cohen, MD
role: Principal Investigator
affiliation: Jewish General Hospital
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung