<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/NCT02204332</url>
  </required_header>
  <id_info>
    <org_study_id>RLL-CAB-2011-01</org_study_id>
    <nct_id>NCT02204332</nct_id>
  </id_info>
  <brief_title>Phase II-b Randomized Clinical Trial of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment</brief_title>
  <acronym>COMETA</acronym>
  <official_title>Phase II-b Randomized Study of Cabazitaxel in Metastatic Colorectal Cancer Resistant to Standard Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinico Universitario de Santiago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundación Ramón Domínguez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinico Universitario de Santiago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine efficacy and safety of cabazitaxel administration&#xD;
      in patients with colorectal cancer resistant to standard treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim analysis performed on the first 10 patients showed no efficacy of cabazitaxel&#xD;
  </why_stopped>
  <start_date>March 2013</start_date>
  <primary_completion_date type="Actual">September 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The efficacy of cabazitaxel measured by estimating the overall response rate (ORR), as the percentage of individuals who achieve a complete tumor response (CR) or partial tumor response (PR) in each arm and between arms.</measure>
    <time_frame>From date of randomization to disease progression or until 24 months from enrolment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>From randomisation to either documented disease progression or death from any cause or until 24 months from enrolment (whichever occurs earlier)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From date of randomization to death from any cause or until 24 months from enrolment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Safety and toxicity in the experimental arm. Toxicity is graded according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE, v 4.0).</measure>
    <time_frame>From the date the informed consent is signed up to 30 days after the last dose</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Cabazitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cabazitaxel at a dose of 25 mg / m² in a 5% dextrose or 0.9% NaCl intravenously over 1 hour, every 3 weeks (1 cycle).&#xD;
Besides, patient will be treated with BSC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Best Supportive Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Best Supportive Care (BSC), with evaluations every 3 weeks (1 cycle).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabazitaxel</intervention_name>
    <arm_group_label>Cabazitaxel</arm_group_label>
    <other_name>Jevtana</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Supportive Care</intervention_name>
    <arm_group_label>Best Supportive Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have given written informed consent.&#xD;
&#xD;
          -  Men and women aged ≥ 18 years.&#xD;
&#xD;
          -  Patients with histologically confirmed metastatic advanced colorectal cancer without&#xD;
             the possibility of potentially curative treatment.&#xD;
&#xD;
          -  Patients with a life expectancy more than three months.&#xD;
&#xD;
          -  Patients with advanced colorectal cancer in progression after receiving standard&#xD;
             treatment.&#xD;
&#xD;
          -  Patients with grade 0-2 functional status, according to Eastern Cooperative Oncology&#xD;
             Group (ECOG).&#xD;
&#xD;
          -  Patients with evaluable tumor by RECIST criteria.&#xD;
&#xD;
          -  Patients recovered and with a degree less than or equal to 1, or baseline of all&#xD;
             important pre-treatment-related AEs (excluding alopecia).&#xD;
&#xD;
          -  Ability and willingness of the patient to consent to participation in the study.&#xD;
&#xD;
          -  Ability to understand and comply with study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a performance status greater than 2, as Eastern Cooperative Oncology&#xD;
             Group (ECOG).&#xD;
&#xD;
          -  Inadequate marrow reserve, within 7 days prior to randomization:&#xD;
&#xD;
               -  absolute neutrophil count &lt;1.5 x 109 / L&#xD;
&#xD;
               -  Hemoglobin &lt;9.0 g / dL&#xD;
&#xD;
               -  Platelet count &lt;100 x 109 / L&#xD;
&#xD;
          -  Inadequate liver function within 7 days prior to randomization:&#xD;
&#xD;
               -  AST (SGOT) and ALT (SGPT)&gt; 3.0 x ULN or 5&gt; x ULN in case of abnormal liver&#xD;
                  function due to underlying liver metastases.&#xD;
&#xD;
               -  Alkaline phosphatase&gt; 3 × ULN (or 5 times the ULN if due to underlying liver&#xD;
                  metastases).&#xD;
&#xD;
               -  Total bilirubin&gt; 1.5 x ULN.&#xD;
&#xD;
          -  Previous history of other malignancy, except for skin basal or squamous cell cancer&#xD;
             with proper treatment, or in situ cervical cancer, or other cancers, in which the&#xD;
             patient has been free of the disease in the last 5 years.&#xD;
&#xD;
          -  Simultaneous treatment with concomitant anticancer therapy.&#xD;
&#xD;
          -  History of brain metastases, uncontrolled compression of spinal cord, or carcinomatous&#xD;
             meningitis, or new evidence of brain or leptomeningeal disease pathologies.&#xD;
&#xD;
          -  Acquired Immunodeficiency Syndrome (AIDS-related diseases) or human immunodeficiency&#xD;
             virus (HIV) or conditions requiring antiretroviral therapy virus.&#xD;
&#xD;
          -  symptomatic grade ≥ 2 peripheral sensory neuropathy, according to NCI-CTCAE v4.0.&#xD;
&#xD;
          -  Any severe acute or chronic medical condition that may affect the patient's ability to&#xD;
             participate in the study, or may lead to unacceptable security risks and&#xD;
             non-compliance with protocol procedures or may interfere with the interpretation of&#xD;
             the study results.&#xD;
&#xD;
          -  Pregnant women or who are breastfeeding. Pregnancy assessment will be conducted by a&#xD;
             test serum or urine during the 7 days prior to randomization.&#xD;
&#xD;
          -  Patient (male or female) of reproductive age who still disagrees with the use of&#xD;
             effective contraception during the treatment period and for at least 3 months after&#xD;
             completion of the treatment period of the study. The definition of &quot;effective method&#xD;
             of birth control&quot; is the opinion of the investigator.&#xD;
&#xD;
          -  Participation in another clinical trial with an investigational drug and / or an&#xD;
             investigational drug as adjunctive therapy within 30 days prior to randomization.&#xD;
&#xD;
          -  Concomitant treatment with prohibited drugs as potent inhibitors or inducers of&#xD;
             cytochrome P450 3A4.&#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>Rafael López López, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Clinico de Santiago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital German Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova</name>
      <address>
        <city>Lérida</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Carlos Haya</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Orense</name>
      <address>
        <city>Orense</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinico Universitario de Santiago</investigator_affiliation>
    <investigator_full_name>Rafael Lopez Lopez</investigator_full_name>
    <investigator_title>MD,PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT02204332
org study id: RLL-CAB-2011-01
nct id: NCT02204332
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine efficacy and safety of cabazitaxel administration
      in patients with colorectal cancer resistant to standard treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The efficacy of cabazitaxel measured by estimating the overall response rate (ORR), as the percentage of individuals who achieve a complete tumor response (CR) or partial tumor response (PR) in each arm and between arms.
time frame: From date of randomization to disease progression or until 24 months from enrolment
measure: Progression-free survival (PFS)
time frame: From randomisation to either documented disease progression or death from any cause or until 24 months from enrolment (whichever occurs earlier)
measure: Overall survival (OS)
time frame: From date of randomization to death from any cause or until 24 months from enrolment
measure: Safety and toxicity in the experimental arm. Toxicity is graded according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE, v 4.0).
time frame: From the date the informed consent is signed up to 30 days after the last dose
arm group label: Cabazitaxel
arm group type: Experimental
description: Cabazitaxel at a dose of 25 mg / m² in a 5% dextrose or 0.9% NaCl intravenously over 1 hour, every 3 weeks (1 cycle).
Besides, patient will be treated with BSC.
arm group label: Best Supportive Care
arm group type: Other
description: Best Supportive Care (BSC), with evaluations every 3 weeks (1 cycle).
intervention type: Drug
intervention name: Cabazitaxel
arm group label: Cabazitaxel
other name: Jevtana
intervention type: Other
intervention name: Best Supportive Care
arm group label: Best Supportive Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rafael López López, MD, PhD
role: Study Chair
affiliation: Hospital Clinico de Santiago
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinico Universitario de Santiago
investigator full name: Rafael Lopez Lopez
investigator title: MD,PhD
mesh term: Colorectal Neoplasms