<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/NCT01703455</url>
  </required_header>
  <id_info>
    <org_study_id>INT29/10</org_study_id>
    <nct_id>NCT01703455</nct_id>
  </id_info>
  <brief_title>Activity of Sorafenib in Salivary Gland Cancer</brief_title>
  <official_title>Sorafenib in Recurrent and/or Metastatic Salivary Gland Carcinomas: Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single agent, prospective, open-label, monocenter, phase II trial of sorafenib in&#xD;
      patients with recurrent and/or metastatic salivary gland carcinoma. This trial will be&#xD;
      conducted with the primary aim to determine the response rate (CR+PR) according to the RECIST&#xD;
      criteria. Response rate according to CHOI criteria, correlation between CHOI criteria and&#xD;
      outcome, disease Control Rate (DCR) and acute toxicity will be evaluated as secondary&#xD;
      objectives.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response</measure>
    <time_frame>8 weeks</time_frame>
    <description>Response Rate according to RECIST criteria. Response will be evaluated every 2 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>response rate according to CHOI criteria</measure>
    <time_frame>8 weeks</time_frame>
    <description>assessment of tumor response according to CHOI criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation between CHOI criteria and outcome</measure>
    <time_frame>one year</time_frame>
    <description>correlation between CHOI criteria and survival (OS and PFS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>adverse events</measure>
    <time_frame>4 weeks</time_frame>
    <description>number of patients with adverse events</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Salivary Gland Cancer</condition>
  <arm_group>
    <arm_group_label>Sorafenib 400 mg twice daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sorafenib 400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sorafenib</intervention_name>
    <description>400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles</description>
    <arm_group_label>Sorafenib 400 mg twice daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven relapsed and/or metastatic salivary gland cancer for which&#xD;
             potentially curative options such as surgery or radiotherapy are not indicated&#xD;
&#xD;
          -  One target lesion measurable by CT-scan or MRI according to RECIST criteria&#xD;
&#xD;
          -  Age + 18 years&#xD;
&#xD;
          -  ECOG 0 or 1&#xD;
&#xD;
          -  Adequate bone marrow, liver and renal function&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic metastatic brain or meningeal tumors&#xD;
&#xD;
          -  History of cardiac disease such as congestive heart failure&gt;NYHA class 2&#xD;
&#xD;
          -  Active CAD&#xD;
&#xD;
          -  Cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension&#xD;
&#xD;
          -  Pregnant or breast-feeding patient&#xD;
&#xD;
          -  Patients with evidence or history of bleeding diathesis&#xD;
&#xD;
          -  Patients undergoing renal dialysis&#xD;
&#xD;
          -  Patients unable to swallow oral medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IRCCS Istituto Nazionale Tumori</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>April 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>August 23, 2019</last_update_submitted>
  <last_update_submitted_qc>August 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</investigator_affiliation>
    <investigator_full_name>Lisa Licitra</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Salivary gland cancer metastatic disease recurrent disease clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salivary Gland Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sorafenib</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/NCT01703455
org study id: INT29/10
nct id: NCT01703455
lead sponsor: 
has dmc: Yes
This is a single agent, prospective, open-label, monocenter, phase II trial of sorafenib in
      patients with recurrent and/or metastatic salivary gland carcinoma. This trial will be
      conducted with the primary aim to determine the response rate (CR+PR) according to the RECIST
      criteria. Response rate according to CHOI criteria, correlation between CHOI criteria and
      outcome, disease Control Rate (DCR) and acute toxicity will be evaluated as secondary
      objectives.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Objective response
time frame: 8 weeks
description: Response Rate according to RECIST criteria. Response will be evaluated every 2 months.
measure: response rate according to CHOI criteria
time frame: 8 weeks
description: assessment of tumor response according to CHOI criteria
measure: correlation between CHOI criteria and outcome
time frame: one year
description: correlation between CHOI criteria and survival (OS and PFS)
measure: adverse events
time frame: 4 weeks
description: number of patients with adverse events
arm group label: Sorafenib 400 mg twice daily
arm group type: Experimental
description: Sorafenib 400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles
intervention type: Drug
intervention name: Sorafenib
description: 400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles
arm group label: Sorafenib 400 mg twice daily
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
investigator full name: Lisa Licitra
investigator title: MD
mesh term: Salivary Gland Neoplasms
mesh term: Sorafenib