<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/NCT03035591</url>
  </required_header>
  <id_info>
    <org_study_id>3121001</org_study_id>
    <nct_id>NCT03035591</nct_id>
  </id_info>
  <brief_title>ODM-207 in Patients With Advance Solid Tumours</brief_title>
  <acronym>BETIDES</acronym>
  <official_title>Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orion Corporation, Orion Pharma</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a first-in-man study to assess the safety and tolerability and to characterise the&#xD;
      pharmacokinetics of ODM-207.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">May 10, 2019</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose</measure>
    <time_frame>28 days</time_frame>
    <description>Highest dose level at which &lt;33% of patients in a cohort experience Dose Limiting Toxicity (DLT)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Solid Tumors</condition>
  <arm_group>
    <arm_group_label>ODM-207</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Escalating doses of ODM-207</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ODM-207</intervention_name>
    <arm_group_label>ODM-207</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically or cytologically confirmed locally advanced or metastatic&#xD;
             cancer for which no effective standard therapy exists or are refractory or resistant&#xD;
             to conventional therapy&#xD;
&#xD;
          -  Life expectancy &gt;12 weeks&#xD;
&#xD;
          -  Patient may have either measurable or non-measurable disease, but must have disease&#xD;
             that can be evaluated for improvement of progression&#xD;
&#xD;
          -  ECOG performance status of 0 to 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of bleeding disorder or significant bleeding episode within 6 months prior to&#xD;
             study treatment&#xD;
&#xD;
          -  Subjects receiving anticoagulants or medications that durably inhibit platelet&#xD;
             function (7-day wash-out prior to study treatment)&#xD;
&#xD;
          -  History of or current leptomeningeal or brain metastasis or spinal cord compression.&#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>Johann De Bono</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICR/Royal Marsden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsinki University Central Hospital, Department of Oncology</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>October 14, 2019</last_update_submitted>
  <last_update_submitted_qc>October 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03035591
org study id: 3121001
nct id: NCT03035591
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a first-in-man study to assess the safety and tolerability and to characterise the
      pharmacokinetics of ODM-207.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum Tolerated Dose
time frame: 28 days
description: Highest dose level at which <33% of patients in a cohort experience Dose Limiting Toxicity (DLT)
arm group label: ODM-207
arm group type: Experimental
description: Escalating doses of ODM-207
intervention type: Drug
intervention name: ODM-207
arm group label: ODM-207
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johann De Bono
role: Principal Investigator
affiliation: ICR/Royal Marsden
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Neoplasms