<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/NCT01694277</url>
  </required_header>
  <id_info>
    <org_study_id>AB11002</org_study_id>
    <nct_id>NCT01694277</nct_id>
  </id_info>
  <brief_title>Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib</brief_title>
  <official_title>A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AB Science</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AB Science</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib&#xD;
      at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after&#xD;
      progression with imatinib.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type&#xD;
      c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote&#xD;
      survival via modulation of immunostimulation-mediated anticancer effects and modulation of&#xD;
      the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib&#xD;
      at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant&#xD;
      gastro-intestinal stromal tumor (GIST).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</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 rate</measure>
    <time_frame>Every 12 weeks until study completion, assessed for a maximum of 60 months</time_frame>
    <description>Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</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 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 and/or CHOI criteria.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Gastrointestinal Stromal Tumors</condition>
  <arm_group>
    <arm_group_label>Masitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive masitinib (12 mg/kg/day), given orally twice daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sunitinib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Masitinib</intervention_name>
    <description>12 mg/kg/day</description>
    <arm_group_label>Masitinib</arm_group_label>
    <other_name>AB1010</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sunitinib</intervention_name>
    <description>50 mg/day</description>
    <arm_group_label>Sunitinib</arm_group_label>
    <other_name>Sutent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main inclusion criteria include:&#xD;
&#xD;
          -  Patient with histological proven metastatic GIST or non-operable locally advanced GIST&#xD;
&#xD;
          -  Patient with c-Kit (CD117) positive tumor detected immuno-histochemically&#xD;
&#xD;
          -  Patient after at least one progression with imatinib at a dose up to 800mg.&#xD;
             Progression is defined as a RECIST 1.1 and/or CHOI disease progression while receiving&#xD;
             imatinib treatment.&#xD;
&#xD;
        Main exclusion criteria include:&#xD;
&#xD;
          -  Patient treated for a cancer other than GIST within 5 years before enrolment, with the&#xD;
             exception of basal cell carcinoma or cervical cancer in situ&#xD;
&#xD;
          -  Patient with active central nervous system (CNS) metastasis or with history of CNS&#xD;
             metastasis&#xD;
&#xD;
          -  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>Axel Le Cesne, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute Gustave Roussy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital l'Archet 2- Service de Cancérologie Digestive</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto per la Ricerca e la Cura del Cancro (IRCC)</name>
      <address>
        <city>Candiolo</city>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus University Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</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>Gastrointestinal Stromal Tumour</keyword>
  <keyword>GIST</keyword>
  <keyword>non-resectable</keyword>
  <keyword>metastatic</keyword>
  <keyword>second line treatment</keyword>
  <keyword>resistance to imatinib</keyword>
  <keyword>tyrosine kinase inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Stromal Tumors</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunitinib</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01694277
org study id: AB11002
nct id: NCT01694277
lead sponsor: 
has dmc: Yes
The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib
      at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after
      progression with imatinib.
Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type
      c-Kit, the juxta membrane domain of c-Kit, and PDGFR. Masitinib is also thought to promote
      survival via modulation of immunostimulation-mediated anticancer effects and modulation of
      the tumor microenvironment. The objective is to compare the efficacy and safety of masitinib
      at 12 mg/kg/day with respect to sunitinib at 50 mg/day in the treatment of imatinib-resistant
      gastro-intestinal stromal tumor (GIST).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
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 rate
time frame: Every 12 weeks until study completion, assessed for a maximum of 60 months
description: Survival rate is defined as the number of patients alive divided by the number of patients in the population of analysis. Assessed at week-8, -16, -24, and every 12 weeks thereafter.
measure: Progression Free Survival (PFS)
time frame: From day of randomization to disease progression or death, assessed for a maximum of 60 months
description: Progression Free Survival 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 and/or CHOI criteria.
arm group label: Masitinib
arm group type: Experimental
description: Participants receive masitinib (12 mg/kg/day), given orally twice daily.
arm group label: Sunitinib
arm group type: Active Comparator
description: Participants receive sunitinib, given at 50 mg/day for 4 consecutive weeks out of 6 weeks, orally
intervention type: Drug
intervention name: Masitinib
description: 12 mg/kg/day
arm group label: Masitinib
other name: AB1010
intervention type: Drug
intervention name: Sunitinib
description: 50 mg/day
arm group label: Sunitinib
other name: Sutent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Axel Le Cesne, M.D., Ph.D
role: Principal Investigator
affiliation: Institute Gustave Roussy
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Italy
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Gastrointestinal Stromal Tumors
mesh term: Sunitinib