<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/NCT02205164</url>
  </required_header>
  <id_info>
    <org_study_id>AS/PALO/002</org_study_id>
    <secondary_id>2011-003823-36</secondary_id>
    <nct_id>NCT02205164</nct_id>
  </id_info>
  <brief_title>Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients</brief_title>
  <official_title>Phase II Randomized Study of Multiple Doses of Palonosetron Plus Aprepitant Versus Multiple Doses of Palonosetron Alone in Preventing CINV in Patients With Newly Diagnosed AML or High-risk MDS Receiving Multiple Days Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Associazione Salentina Angela Serra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Associazione Salentina Angela Serra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of&#xD;
      palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in&#xD;
      preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, randomized, comparative, multicenter phase II study in patients with&#xD;
      AML scheduled to receive multiple days chemotherapy.&#xD;
&#xD;
      Patients will receive either PALO+APR or the PALO regimen in a 1:1 ratio according to a&#xD;
      computer-generated, random allocation schedule. Below are described the details for both&#xD;
      antiemetic regimens:&#xD;
&#xD;
      PALO+APR regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1&#xD;
      hour before chemotherapy ) and multiple intravenous bolus of Palonosetron without&#xD;
      dexamethasone, prior to the administration of chemotherapy, starting the first day of&#xD;
      treatment.&#xD;
&#xD;
      PALO regimen: multiple intravenous bolus of Palonosetron without dexamethasone, prior to the&#xD;
      administration of chemotherapy, starting the first day of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <phase>Phase 2</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>Complete Response</measure>
    <time_frame>5 days after chemotherapy</time_frame>
    <description>The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Control</measure>
    <time_frame>5 days after chemotherapy</time_frame>
    <description>No emetic episode, no need for rescue medication, with a maximum grade of mild nausea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emesis-free</measure>
    <time_frame>5 days after chemotherapy</time_frame>
    <description>Percentage of patients without emetic episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of nausea</measure>
    <time_frame>5 days after chemotherapy</time_frame>
    <description>Presence of nausea graded according to Likert scale (none, mild, moderate and severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment failure</measure>
    <time_frame>5 days after chemotherapy</time_frame>
    <description>Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient global satisfaction</measure>
    <time_frame>5 days after chemotherapy</time_frame>
    <description>Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>5 days after chemotherapy</time_frame>
    <description>Number of patients experienced at least one adverse events related to study drug administration.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Chemotherapy Induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Palonosetron + Aprepitant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral aprepitant will be given on days 1-3 (day 1, 125 mg 1 h before chemohterapy; days 2-3, 80 mg) multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Palonosetron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palonosetron + Aprepitant</intervention_name>
    <description>Aloxi 0.25mg Emend 125/80/80 mg</description>
    <arm_group_label>Palonosetron + Aprepitant</arm_group_label>
    <other_name>Aloxi + Emend</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palonosetron</intervention_name>
    <description>Aloxi 0.25mg</description>
    <arm_group_label>Palonosetron</arm_group_label>
    <other_name>Aloxi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS&#xD;
&#xD;
          -  Patient eligible for AML-like induction therapy&#xD;
&#xD;
          -  Candidate for multiple-days chemotherapy (minimum 3 days)&#xD;
&#xD;
          -  Age more, equal18 years&#xD;
&#xD;
          -  ECOG 0-2&#xD;
&#xD;
          -  Not pregnant or nursing&#xD;
&#xD;
          -  Must be able to complete the patient's diary&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AML or HR-MDS therapy-related&#xD;
&#xD;
          -  Active infection requiring intravenous antibiotics&#xD;
&#xD;
          -  Prior malignancies at other sites except surgically treated non-melanoma skin cancer,&#xD;
             prostate cancer, superficial cervical cancer, or other cancer from which the patient&#xD;
             had been disease-free for more/equal 5 years&#xD;
&#xD;
          -  Unacceptable hepatic function (more of 2 times the upper limit of normal for liver&#xD;
             transaminases) and renal function (creatinine more of 1.5 times the upper limit of&#xD;
             normal) unless disease-related&#xD;
&#xD;
          -  Myocardial infarction within the past 6 months&#xD;
&#xD;
          -  Psychiatric or CNS disorders interfering with ability to comply with study protocol&#xD;
&#xD;
          -  Known hypersensitivity to 5-HT3 antagonists and their components CSF involvement&#xD;
&#xD;
          -  Pre-existing nausea or vomiting&#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>Nicola Di Renzo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale Vito Fazzi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicola Di Renzo, MD</last_name>
    <email>direnzo.ematolecce@libero.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claudia Quintavalle, BsC</last_name>
    <email>quinta.ematolecce@libero.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Università-Azienda Policlinico di Bari</name>
      <address>
        <city>Bari</city>
        <state>BA</state>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Perrino</name>
      <address>
        <city>Brindisi</city>
        <state>BR</state>
        <zip>72010</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Melpignano, MD</last_name>
      <email>brinemat@tin.it</email>
    </contact>
    <investigator>
      <last_name>Angela Melpignano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Pugliese-Ciacco</name>
      <address>
        <city>Catanzaro</city>
        <state>CZ</state>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>IRCCS Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>FG</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Cascavilla, MD</last_name>
      <email>nicola.cascavilla@tin.it</email>
    </contact>
    <investigator>
      <last_name>Nicola Cascavilla, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Vito Fazzi</name>
      <address>
        <city>Lecce</city>
        <state>LE</state>
        <zip>73100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Di Renzo, MD</last_name>
      <email>direnzo.ematolecce@libero.it</email>
    </contact>
    <investigator>
      <last_name>Nicola Di Renzo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale &quot;Cardinale Panico&quot;</name>
      <address>
        <city>Tricase</city>
        <state>LE</state>
        <zip>73100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincenzo Pavore, MD</last_name>
      <email>salentoematologia@piafondazionepanico.it</email>
    </contact>
    <investigator>
      <last_name>Vincenzo Pavone, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>A.O. Riuniti Papardo - Piemonte</name>
      <address>
        <city>Messina</city>
        <state>ME</state>
        <zip>98121</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donato Mannina, MD</last_name>
      <email>donadani@tiscali.it</email>
    </contact>
    <investigator>
      <last_name>Donato Mannina, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Casa di Cura &quot;La Maddalena&quot;</name>
      <address>
        <city>Palermo</city>
        <state>PA</state>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maurizio Musso, MD</last_name>
      <email>mamusso@libero.it</email>
    </contact>
    <investigator>
      <last_name>Maurizio Musso, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Ascoli Civico Palermo</name>
      <address>
        <city>Palermo</city>
        <state>PA</state>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anxur Merenda, MD</last_name>
      <email>anxurmerenda@libero.it</email>
    </contact>
    <investigator>
      <last_name>Anxur Merenda, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Moscati</name>
      <address>
        <city>Taranto</city>
        <state>TA</state>
        <zip>74100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrizio Mazza, MD</last_name>
      <email>ematologia.taranto@libero.it</email>
    </contact>
    <investigator>
      <last_name>Patrizio Mazza, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ARON &quot; Cardarelli&quot;</name>
      <address>
        <city>Napoli</city>
        <zip>80121</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felicetto Ferrara, MD</last_name>
      <email>felicettoferrara@katamail.com</email>
    </contact>
    <investigator>
      <last_name>Felicetto Ferrara, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>palonosetron</keyword>
  <keyword>aprepitant</keyword>
  <keyword>CINV</keyword>
  <keyword>AML</keyword>
  <keyword>multiple-days</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aprepitant</mesh_term>
    <mesh_term>Palonosetron</mesh_term>
  </intervention_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/NCT02205164
org study id: AS/PALO/002
secondary id: 2011-003823-36
nct id: NCT02205164
lead sponsor: 
has dmc: No
The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of
      palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in
      preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.
This is an open-label, randomized, comparative, multicenter phase II study in patients with
      AML scheduled to receive multiple days chemotherapy.

      Patients will receive either PALO+APR or the PALO regimen in a 1:1 ratio according to a
      computer-generated, random allocation schedule. Below are described the details for both
      antiemetic regimens:

      PALO+APR regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1
      hour before chemotherapy ) and multiple intravenous bolus of Palonosetron without
      dexamethasone, prior to the administration of chemotherapy, starting the first day of
      treatment.

      PALO regimen: multiple intravenous bolus of Palonosetron without dexamethasone, prior to the
      administration of chemotherapy, starting the first day of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Complete Response
time frame: 5 days after chemotherapy
description: The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase.
measure: Complete Control
time frame: 5 days after chemotherapy
description: No emetic episode, no need for rescue medication, with a maximum grade of mild nausea
measure: Emesis-free
time frame: 5 days after chemotherapy
description: Percentage of patients without emetic episodes
measure: Presence of nausea
time frame: 5 days after chemotherapy
description: Presence of nausea graded according to Likert scale (none, mild, moderate and severe)
measure: Treatment failure
time frame: 5 days after chemotherapy
description: Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)
measure: Patient global satisfaction
time frame: 5 days after chemotherapy
description: Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS)
measure: Safety and tolerability
time frame: 5 days after chemotherapy
description: Number of patients experienced at least one adverse events related to study drug administration.
arm group label: Palonosetron + Aprepitant
arm group type: Experimental
description: Oral aprepitant will be given on days 1-3 (day 1, 125 mg 1 h before chemohterapy; days 2-3, 80 mg) multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.
arm group label: Palonosetron
arm group type: Active Comparator
description: multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.
intervention type: Drug
intervention name: Palonosetron + Aprepitant
description: Aloxi 0.25mg Emend 125/80/80 mg
arm group label: Palonosetron + Aprepitant
other name: Aloxi + Emend
intervention type: Drug
intervention name: Palonosetron
description: Aloxi 0.25mg
arm group label: Palonosetron
other name: Aloxi
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicola Di Renzo, MD
role: Principal Investigator
affiliation: Ospedale Vito Fazzi
last name: Nicola Di Renzo, MD
email: direnzo.ematolecce@libero.it
last name: Claudia Quintavalle, BsC
email: quinta.ematolecce@libero.it
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Aprepitant
mesh term: Palonosetron