<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/NCT03766295</url>
  </required_header>
  <id_info>
    <org_study_id>AB12005</org_study_id>
    <nct_id>NCT03766295</nct_id>
  </id_info>
  <brief_title>Masitinib Plus Gemcitabine in Pancreatic Cancer</brief_title>
  <official_title>A Prospective, Multicenter, Double-randomized, Double-blind, 2-parallel Groups, Phase 3 Study to Compare as First Line Therapy Efficacy and Safety of Masitinib in Combination With Gemcitabine, to Gemcitabine in Combination With Placebo, in the Treatment of Patients With Non Resectable Locally Advanced or Metastatic Pancreatic Cancer</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to compare efficacy and safety of masitinib in combination with gemcitabine&#xD;
      to placebo in combination with gemcitabine, in treatment of patients with locally advanced or&#xD;
      metastatic pancreatic cancer and who have pain related to the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via&#xD;
      modulation of immunostimulation-mediated anticancer effects and modulation of the tumor&#xD;
      microenvironment. The objective of this study is to evaluate the efficacy and safety of&#xD;
      masitinib in combination with gemcitabine with respect to placebo in combination with&#xD;
      gemcitabine for the treatment of non resectable locally advanced or metastatic pancreatic&#xD;
      cancer patients with pain related to the disease. Approximately 330 patients with pain Visual&#xD;
      Analogue Scale (VAS) &gt; 20 and/or treated with 'opioid analgesics' dose ≥ 1 mg/kg/day at&#xD;
      baseline will be randomized in a 2:1 ratio to the masitinib and placebo arms, respectively.&#xD;
      The primary outcome measure is overall survival (OS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (median)</measure>
    <time_frame>From day of randomization to death, assessed for a maximum of 60 months</time_frame>
    <description>Overall survival 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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival rates</measure>
    <time_frame>every 24 weeks</time_frame>
    <description>The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution</description>
  </secondary_outcome>
  <secondary_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 by the investigator on CT scan according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">377</enrollment>
  <condition>Locally Advanced or Metastatic Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Masitinib &amp; gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo &amp; gemcitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive matching placebo, given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Masitinib</intervention_name>
    <arm_group_label>Masitinib &amp; gemcitabine</arm_group_label>
    <other_name>AB1010</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <arm_group_label>Masitinib &amp; gemcitabine</arm_group_label>
    <arm_group_label>Placebo &amp; gemcitabine</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo &amp; gemcitabine</arm_group_label>
    <other_name>Placebo Oral Tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main inclusion criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed adenocarcinoma of the pancreas, non&#xD;
             resectable locally advanced or metastatic stage&#xD;
&#xD;
          2. Patient with pain related to the disease, as assessed by the investigator and the&#xD;
             patient:&#xD;
&#xD;
               -  Pain related to the disease as assessed by the investigator is defined as&#xD;
                  clinical and documented evaluation by the investigator during physical&#xD;
                  examinations at screening and/or baseline.&#xD;
&#xD;
               -  Pain, as assessed by the patient is defined as at least one value out of two&#xD;
                  values &gt; 20mm on Visual Analogue Scale at screening or baseline. Visual Analogic&#xD;
                  scale consists in the visual representation of pain amplitude as perceived by the&#xD;
                  patient. The amplitude is represented by a 100 mm long line having no reference&#xD;
                  marks. One extremity indicates an absence of pain (0 value) and the other the&#xD;
                  worst imaginable pain (100 value).&#xD;
&#xD;
        OR&#xD;
&#xD;
        - Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).&#xD;
&#xD;
        3. Chemotherapy naïve patient for the advanced/metastatic disease&#xD;
&#xD;
        Main exclusion criteria:&#xD;
&#xD;
          1. Patient with no pain related to the disease (as defined in the inclusion criterion&#xD;
             number 2)&#xD;
&#xD;
          2. Pregnant or nursing female patient&#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>Joël Ezenfis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier de Longjumeau, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital AZ Sint-Jan</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique de Limoges site CHENIEUX</name>
      <address>
        <city>Limoges</city>
        <zip>87000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Longjumeau</name>
      <address>
        <city>Longjumeau</city>
        <zip>91160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General University Hospital of Patras</name>
      <address>
        <city>Patras</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanjeevani CBCC USA Cancer Hospital</name>
      <address>
        <city>Raipur</city>
        <zip>492001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omsk Clinical oncology dispensary Omsk</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Oncology Institute</name>
      <address>
        <city>Bratislava</city>
        <zip>833 10</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Salah Azaiez de Cancerologie</name>
      <address>
        <city>Bab Saadoun</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center of Surgical Innovations</name>
      <address>
        <city>Kiev</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Greece</country>
    <country>India</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Tunisia</country>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <disposition_first_submitted>December 7, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>December 7, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 8, 2020</disposition_first_posted>
  <last_update_submitted>December 7, 2020</last_update_submitted>
  <last_update_submitted_qc>December 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>tyrosine kinase inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03766295
org study id: AB12005
nct id: NCT03766295
lead sponsor: 
is fda regulated drug: Yes
The objective is to compare efficacy and safety of masitinib in combination with gemcitabine
      to placebo in combination with gemcitabine, in treatment of patients with locally advanced or
      metastatic pancreatic cancer and who have pain related to the disease.
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. The objective of this study is to evaluate the efficacy and safety of
      masitinib in combination with gemcitabine with respect to placebo in combination with
      gemcitabine for the treatment of non resectable locally advanced or metastatic pancreatic
      cancer patients with pain related to the disease. Approximately 330 patients with pain Visual
      Analogue Scale (VAS) > 20 and/or treated with 'opioid analgesics' dose ≥ 1 mg/kg/day at
      baseline will be randomized in a 2:1 ratio to the masitinib and placebo arms, respectively.
      The primary outcome measure is overall survival (OS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Overall Survival (median)
time frame: From day of randomization to death, assessed for a maximum of 60 months
description: Overall survival 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.
measure: Survival rates
time frame: every 24 weeks
description: The proportion of patients alive at each time point, estimated with Kaplan-Meier distribution
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 by the investigator on CT scan according to RECIST 1.1 criteria
arm group label: Masitinib & gemcitabine
arm group type: Experimental
description: Participants receive masitinib (6 mg/kg/day), given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.
arm group label: Placebo & gemcitabine
arm group type: Active Comparator
description: Participants receive matching placebo, given orally twice daily, plus gemcitabine at 1000mg/m2 by intravenous infusion during 30 minutes, once every 7 days, for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of an IV infusion, once every 7 days, for 3 consecutive weeks out of every 4 weeks, until disease progression, death, limiting toxicity or patient consent withdrawal.
intervention type: Drug
intervention name: Masitinib
arm group label: Masitinib & gemcitabine
other name: AB1010
intervention type: Drug
intervention name: Gemcitabine
arm group label: Masitinib & gemcitabine
arm group label: Placebo & gemcitabine
other name: Gemzar
intervention type: Drug
intervention name: Placebo
arm group label: Placebo & gemcitabine
other name: Placebo Oral Tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joël Ezenfis, MD
role: Principal Investigator
affiliation: Centre Hospitalier de Longjumeau, France
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: France
country: Greece
country: India
country: Russian Federation
country: Slovakia
country: Tunisia
country: Ukraine
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Gemcitabine
sharing ipd: Undecided