<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/NCT04416646</url>
  </required_header>
  <id_info>
    <org_study_id>ZEBRA</org_study_id>
    <nct_id>NCT04416646</nct_id>
  </id_info>
  <brief_title>Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma</brief_title>
  <acronym>ZEBRA</acronym>
  <official_title>Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma: Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Oncologico Veneto IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Oncologico Veneto IRCCS</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>
      The purpose of this study is to evaluate the safety and efficacy of Cabozantinib in the&#xD;
      treatment of patients with renal cell carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 27, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Clinical tolerability of Cabozantinib</measure>
    <time_frame>Average of 1 year</time_frame>
    <description>the main purpose is to register the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of response rate of patients treated with Cabozantinib.</measure>
    <time_frame>From date of randomization until the date of last documented, assessed up to 18 months&quot;</time_frame>
    <description>according to RECIST criteria, only patients with measurable disease will be evaluated for response</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabozantinib</intervention_name>
    <description>The regimen will be a single oral dose administered daily on a continuous schedule, taken with or without food. The standard dose is 60 mg per day, which can be reduced to 40 or 20 mg according to the latest version of the Summary of Product Characteristics-SPC available. The treating oncologist will evaluate the opportunity to prudentially start treatment at 40 mg/daily in patients screening positively at G8 screening tool, and then escalate to 60 mg/daily only in case of absence of toxicity ³grade 2 at subsequent cycles. Temporary suspensions of treatment are allowed according to the local practice and will be registered if ³ 7 days.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be enrolled from Italian oncology Centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 70 years&#xD;
&#xD;
          -  Histological diagnosis of Renal Cell Carcinoma (any histology, with the exclusion of&#xD;
             urothelial carcinomas)&#xD;
&#xD;
          -  Locally advanced disease or metastatic disease (any site, measurable or non-&#xD;
             measurable lesions), progressing after at least one line of VEGFR-targeted therapy (as&#xD;
             per official registration of the drug at AIFA, in case of extension to first-line&#xD;
             treatment, TKI-naïve patients will also be eligible), with or without previous&#xD;
             exposure to check-point inhibitors.&#xD;
&#xD;
          -  Life expectancy of at least 3 months&#xD;
&#xD;
          -  Adequate hepatic, renal and bone marrow function as judged by the treating oncologist.&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to swallow cabozantinib tablets&#xD;
&#xD;
          -  Serious comorbidities or cognitive impairment, which may interfere with cabozantinib&#xD;
             administration and/or patient's follow up, as judged by the treating physician&#xD;
&#xD;
          -  Absence of a reliable caregiver, as judged by the treating physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto</name>
      <address>
        <city>Padova</city>
        <zip>35100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Oncologico Veneto IRCCS</investigator_affiliation>
    <investigator_full_name>Umberto basso</investigator_full_name>
    <investigator_title>Doctor of Medicine I level</investigator_title>
  </responsible_party>
  <keyword>Cabozantinib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_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/NCT04416646
org study id: ZEBRA
nct id: NCT04416646
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of Cabozantinib in the
      treatment of patients with renal cell carcinoma.
observational model: Cohort
time perspective: Prospective
measure: Clinical tolerability of Cabozantinib
time frame: Average of 1 year
description: the main purpose is to register the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measure: Description of response rate of patients treated with Cabozantinib.
time frame: From date of randomization until the date of last documented, assessed up to 18 months"
description: according to RECIST criteria, only patients with measurable disease will be evaluated for response
intervention type: Drug
intervention name: Cabozantinib
description: The regimen will be a single oral dose administered daily on a continuous schedule, taken with or without food. The standard dose is 60 mg per day, which can be reduced to 40 or 20 mg according to the latest version of the Summary of Product Characteristics-SPC available. The treating oncologist will evaluate the opportunity to prudentially start treatment at 40 mg/daily in patients screening positively at G8 screening tool, and then escalate to 60 mg/daily only in case of absence of toxicity ³grade 2 at subsequent cycles. Temporary suspensions of treatment are allowed according to the local practice and will be registered if ³ 7 days.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto Oncologico Veneto IRCCS
investigator full name: Umberto basso
investigator title: Doctor of Medicine I level
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
sharing ipd: Undecided