<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/NCT03761225</url>
  </required_header>
  <id_info>
    <org_study_id>AB12003</org_study_id>
    <nct_id>NCT03761225</nct_id>
  </id_info>
  <brief_title>Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer</brief_title>
  <official_title>A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Docetaxel to Placebo in Combination With Docetaxel in First Line Metastatic Castrate Resistant Prostate Cancer (mCRPC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AB Science</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AB Science</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic&#xD;
      castration-resistant prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate the efficacy and safety of masitinib in&#xD;
      combination with docetaxel and prednisone with respect to placebo in combination with&#xD;
      docetaxel and prednisone in the treatment of first line metastatic Castrate Resistant&#xD;
      Prostate Cancer (mCRPC). Approximately 580 patients will be randomized in 2 groups with a&#xD;
      ratio 1:1. The primary outcome measure is progression free survival. Masitinib is a selective&#xD;
      tyrosine kinase inhibitor that is thought to promote survival via modulation of&#xD;
      immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">December 15, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From day of randomization to disease progression or death, assessed for a maximum of 60 months</time_frame>
    <description>Progression Free Survival (PFS) is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From day of randomization to death, assessed for a maximum of 60 months</time_frame>
    <description>Overall survival (OS) is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">714</enrollment>
  <condition>Metastatic Castrate Resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Masitinib &amp; docetaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; docetaxel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive placebo (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Masitinib</intervention_name>
    <arm_group_label>Masitinib &amp; docetaxel</arm_group_label>
    <other_name>AB1010</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <arm_group_label>Masitinib &amp; docetaxel</arm_group_label>
    <arm_group_label>Placebo &amp; docetaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <arm_group_label>Masitinib &amp; docetaxel</arm_group_label>
    <arm_group_label>Placebo &amp; docetaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo &amp; docetaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed metastatic Castrate Resistant Prostate&#xD;
             Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or&#xD;
             antagonist or patient with surgical castration; hormonal castration confirmed&#xD;
             biologically (testosterone &lt; 0.5ng/ml) with one of the following criteria:&#xD;
&#xD;
               -  Pre-treated with abiraterone with documented progressive disease, OR&#xD;
&#xD;
               -  Indicated for initiating docetaxel treatment (e.g., widespread visceral disease&#xD;
                  or rapidly progressive disease).&#xD;
&#xD;
          2. Patient with evidence of progressive metastatic disease as assessed according to the&#xD;
             Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.&#xD;
&#xD;
          3. Patient with adequate organ function as per protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patient who has been previously treated with chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique Spaeth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Polyclinique d'oncologie de Gentilly, Nancy, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <zip>13001</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique d'oncologie de Gentilly</name>
      <address>
        <city>Nancy</city>
        <zip>54100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanjay Gandhi Post Graduate Institute of Medical Sciences</name>
      <address>
        <city>Lucknow</city>
        <zip>226014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Riferimento Oncologico</name>
      <address>
        <city>Aviano</city>
        <zip>33081</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <zip>56100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universiti Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Oncology Dispensary</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic Andros LLC</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197136</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>India</country>
    <country>Italy</country>
    <country>Malaysia</country>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <disposition_first_submitted>June 3, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>June 3, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 11, 2021</disposition_first_posted>
  <last_update_submitted>June 3, 2021</last_update_submitted>
  <last_update_submitted_qc>June 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metastatic castration-resistant prostate cancer</keyword>
  <keyword>metastatic hormone-resistant prostate cancer</keyword>
  <keyword>tyrosine kinase inhibitor</keyword>
  <keyword>mCRPC</keyword>
  <keyword>mHRPC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03761225
org study id: AB12003
nct id: NCT03761225
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic
      castration-resistant prostate cancer.
The objective of this study is to evaluate the efficacy and safety of masitinib in
      combination with docetaxel and prednisone with respect to placebo in combination with
      docetaxel and prednisone in the treatment of first line metastatic Castrate Resistant
      Prostate Cancer (mCRPC). Approximately 580 patients will be randomized in 2 groups with a
      ratio 1:1. The primary outcome measure is progression free survival. Masitinib is a selective
      tyrosine kinase inhibitor that is thought to promote survival via modulation of
      immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Progression Free Survival
time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
description: Progression Free Survival (PFS) is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.
measure: Overall Survival
time frame: From day of randomization to death, assessed for a maximum of 60 months
description: Overall survival (OS) is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.
arm group label: Masitinib & docetaxel
arm group type: Experimental
description: Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.
arm group label: Placebo & docetaxel
arm group type: Placebo Comparator
description: Participants receive placebo (6 mg/kg/day), given orally twice daily, plus docetaxel 75 mg/m2 by intravenous infusion during 1 hour, once every 3 weeks (1 cycle = 21 days) for 6 cycles (8 to 10 cycles can be performed according to patient's tolerance) plus prednisone according to usual practice.
intervention type: Drug
intervention name: Masitinib
arm group label: Masitinib & docetaxel
other name: AB1010
intervention type: Drug
intervention name: Docetaxel
arm group label: Masitinib & docetaxel
arm group label: Placebo & docetaxel
intervention type: Drug
intervention name: Prednisone
arm group label: Masitinib & docetaxel
arm group label: Placebo & docetaxel
intervention type: Drug
intervention name: Placebo
arm group label: Placebo & docetaxel
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique Spaeth, MD
role: Principal Investigator
affiliation: Polyclinique d'oncologie de Gentilly, Nancy, France
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: France
country: India
country: Italy
country: Malaysia
country: Russian Federation
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Docetaxel
sharing ipd: No