<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/NCT03008187</url>
  </required_header>
  <id_info>
    <org_study_id>CLI24-001</org_study_id>
    <nct_id>NCT03008187</nct_id>
  </id_info>
  <brief_title>SEL24/MEN1703 in Patients With Acute Myeloid Leukemia</brief_title>
  <official_title>A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Menarini Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medpace, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Theradex</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Menarini Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the clinical trial is to identify the maximum tolerated dose of SEL24/MEN1703&#xD;
      and to further investigate its safety profile in patients with Acute Myeloid Leukemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated&#xD;
      dose of SEL24/MEN1703 in patients with Acute Myeloid Leukemia.&#xD;
&#xD;
      The clinical trial will investigate the safety profile and anti-leukemic activity of&#xD;
      SEL24/MEN1703 in patients with Acute Myeloid Leukemia and that have no standard therapeutic&#xD;
      options available.&#xD;
&#xD;
      The clinical trial encompasses two parts:&#xD;
&#xD;
        -  Part 1, ascending dose levels: the main purpose of this part of the clinical trial is to&#xD;
           determine the highest dose of SEL24/MEN1703 considered to be well tolerated.&#xD;
&#xD;
        -  Part 2: Expansion cohort: the main purpose of this part of the clinical trial is to&#xD;
           assess the safety and anti-leukemia activity of SEL24/MEN1703 given at the highest&#xD;
           tolerated dose in patient with relapsed/refractory Acute Myeloid Leukemia, either all&#xD;
           comers as well as harboring IDH1/IDH2 mutations.&#xD;
&#xD;
      Patients participating to the clinical trial will take the study drug as oral capsules once&#xD;
      daily for 14 consecutive days over a 21-day treatment cycle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">May 11, 2023</completion_date>
  <primary_completion_date type="Actual">May 11, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose limiting toxicity (DLT) evaluation</measure>
    <time_frame>DLTs in patients during their first 21-day treatment cycle</time_frame>
    <description>Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety profile of single agent SEL24/MEN1703</measure>
    <time_frame>From Cycle 1 Day 1 to Final Study Visit (up to 30 days after last administered dose). Each Cycle lasts 21 days.</time_frame>
    <description>Number and frequency of AEs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>SEL24/MEN1703</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.&#xD;
Part 1: ascending dose levels (cohort) will be tested in at least 3 patients. Any cohort in which 1 patient experiences a dose-limiting toxicity will be expanded up to 6 patients.&#xD;
Part 2: testing at the dose of SEL24/MEN1703 which have demonstrated to be adequately tolerated in Part 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SEL24/MEN1703</intervention_name>
    <description>SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.</description>
    <arm_group_label>SEL24/MEN1703</arm_group_label>
    <other_name>SEL24-B489</other_name>
    <other_name>MEN1703</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with diagnosis of Acute Myeloid Leukemia, all comers (completed) and bearing&#xD;
             IDH1 or IDH2 mutation (open for recruitment)&#xD;
&#xD;
          -  Patient has no standard therapeutic options available and has either Relapsed AML&#xD;
             unsuitable for intensive chemotherapy and not eligible for any approved targeted&#xD;
             therapy or Primary refractory AML unsuitable for intensive chemotherapy and not&#xD;
             eligible for any approved targeted therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anti-cancer treatments (including cytotoxic chemotherapy, radiotherapy, hormonal&#xD;
             therapy, biologic, immunotherapy or investigational drugs) received within 14 days or&#xD;
             5 half-lives for targeted therapies (whichever is shorter) before first dose of study&#xD;
             drug (to be supplemented)&#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>Farhad Ravandi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Leukemia, MDACC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic, Taussig Cancer Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Baylor Charles A. Sammons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori</name>
      <address>
        <city>Meldola</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Monza - Ospedale San Gerardo</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Haematology and Blood Transfusion</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii z Pododdzialem Chemioterapi</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Català d'Oncologia</name>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AML</keyword>
  <keyword>Relapsed/Refractory Acute Myeloid Leukemia</keyword>
  <keyword>IDH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03008187
org study id: CLI24-001
nct id: NCT03008187
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the clinical trial is to identify the maximum tolerated dose of SEL24/MEN1703
      and to further investigate its safety profile in patients with Acute Myeloid Leukemia.
Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated
      dose of SEL24/MEN1703 in patients with Acute Myeloid Leukemia.

      The clinical trial will investigate the safety profile and anti-leukemic activity of
      SEL24/MEN1703 in patients with Acute Myeloid Leukemia and that have no standard therapeutic
      options available.

      The clinical trial encompasses two parts:

        -  Part 1, ascending dose levels: the main purpose of this part of the clinical trial is to
           determine the highest dose of SEL24/MEN1703 considered to be well tolerated.

        -  Part 2: Expansion cohort: the main purpose of this part of the clinical trial is to
           assess the safety and anti-leukemia activity of SEL24/MEN1703 given at the highest
           tolerated dose in patient with relapsed/refractory Acute Myeloid Leukemia, either all
           comers as well as harboring IDH1/IDH2 mutations.

      Patients participating to the clinical trial will take the study drug as oral capsules once
      daily for 14 consecutive days over a 21-day treatment cycle.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose limiting toxicity (DLT) evaluation
time frame: DLTs in patients during their first 21-day treatment cycle
description: Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate
measure: Safety profile of single agent SEL24/MEN1703
time frame: From Cycle 1 Day 1 to Final Study Visit (up to 30 days after last administered dose). Each Cycle lasts 21 days.
description: Number and frequency of AEs
arm group label: SEL24/MEN1703
arm group type: Experimental
description: SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.
Part 1: ascending dose levels (cohort) will be tested in at least 3 patients. Any cohort in which 1 patient experiences a dose-limiting toxicity will be expanded up to 6 patients.
Part 2: testing at the dose of SEL24/MEN1703 which have demonstrated to be adequately tolerated in Part 1.
intervention type: Drug
intervention name: SEL24/MEN1703
description: SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.
arm group label: SEL24/MEN1703
other name: SEL24-B489
other name: MEN1703
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Farhad Ravandi, MD
role: Principal Investigator
affiliation: Department of Leukemia, MDACC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
country: Poland
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No