<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/NCT03831633</url>
  </required_header>
  <id_info>
    <org_study_id>PRAKYFRA-01</org_study_id>
    <nct_id>NCT03831633</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients</brief_title>
  <official_title>A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VIFORFRANCE</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VIFORFRANCE</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pragmatic trial addresses the clinical gap through the generation of evidence on the&#xD;
      comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in&#xD;
      the real-life setting&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 19, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anti-emetic response</measure>
    <time_frame>1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.</time_frame>
    <description>Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">426</enrollment>
  <condition>Oncology</condition>
  <arm_group>
    <arm_group_label>AKYNZEO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Akynzeo</intervention_name>
    <description>1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron).&#xD;
- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4</description>
    <arm_group_label>AKYNZEO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3)&#xD;
IV ondansetron 8 mg on Day 1&#xD;
Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, Age ≥ 18 years&#xD;
&#xD;
          -  Have a histological or cytological confirmed solid tumor malignancy&#xD;
&#xD;
          -  Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC)&#xD;
             based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of&#xD;
             solid malignant tumor&#xD;
&#xD;
          -  Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care&#xD;
             according to the summary of product characteristics based on the judgement of their&#xD;
             investigator's&#xD;
&#xD;
          -  Naïve of CT&#xD;
&#xD;
          -  ECOG performance up to 2&#xD;
&#xD;
          -  Able to read, understand and follow the study procedures&#xD;
&#xD;
          -  Patient with Health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and breastfeeding women;&#xD;
&#xD;
          -  Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or&#xD;
             Emend®;&#xD;
&#xD;
          -  Protected patients: majors under guardianship, tutorship or other legal protection,&#xD;
             deprived of liberty by judicial or administrative decision&#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_contact>
    <last_name>Stéphane OUARY</last_name>
    <phone>+33662755802</phone>
    <phone_ext>5802</phone_ext>
    <email>stephane.ouary@capionis.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Avicenne</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ZELEK</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</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>Vomiting</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/NCT03831633
org study id: PRAKYFRA-01
nct id: NCT03831633
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pragmatic trial addresses the clinical gap through the generation of evidence on the
      comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in
      the real-life setting
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Anti-emetic response
time frame: 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.
description: Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen
arm group label: AKYNZEO
arm group type: Experimental
arm group label: Standard of Care
arm group type: Active Comparator
intervention type: Drug
intervention name: Akynzeo
description: 1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron).
- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4
arm group label: AKYNZEO
intervention type: Drug
intervention name: Standard of Care
description: oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3)
IV ondansetron 8 mg on Day 1
Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stéphane OUARY
phone: +33662755802
phone ext: 5802
email: stephane.ouary@capionis.com
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Vomiting
sharing ipd: No