<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/NCT01709734</url>
  </required_header>
  <id_info>
    <org_study_id>TOK-200-10</org_study_id>
    <nct_id>NCT01709734</nct_id>
  </id_info>
  <brief_title>A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer</brief_title>
  <acronym>ARMOR2</acronym>
  <official_title>ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LTN PHARMACEUTICALS, INC.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LTN PHARMACEUTICALS, INC.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration&#xD;
      resistant prostate cancer (CRPC) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and&#xD;
      target patient population and Part 2 will be expansion of the dose and patient population&#xD;
      selected in Part 1. For eligible patients, there will be an optional extension dosing&#xD;
      following the completion of Part 1 or Part 2 of the trial.&#xD;
&#xD;
      Obtaining of informed consent and screening may be performed up to 28 days prior to&#xD;
      enrollment. Each patient will be able to receive his specified regimen for 3 consecutive&#xD;
      cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit&#xD;
      assessments will be used to determine outcome and dosing may continue up to an additional 2&#xD;
      weeks until the results of all assessments are obtained. Eligible patients may continue&#xD;
      treatment in an optional extension period following the completion of the primary parts of&#xD;
      this trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated prematurely in all investigational study centers upon recommendation from&#xD;
    the study's Data Monitoring Committee (DMC).&#xD;
&#xD;
    Study was stopped due to lack of efficacy.&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Confirmation of recommended dose and patient population for Part 2 of the study.</measure>
    <time_frame>3 months</time_frame>
    <description>Confirmation of recommended dose and patient population for Part 2 of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of efficacy by means of PSA response.</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of efficacy by means of PSA response.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Confirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose A - galeterone tablets once daily PO for three months + extension&#xD;
Dose B - galeterone tablets once daily PO for three months + extension&#xD;
Dose C - galeterone tablets once daily PO for three months + extension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>galeterone</intervention_name>
    <arm_group_label>Dose Confirmation</arm_group_label>
    <arm_group_label>Dose Expansion</arm_group_label>
    <other_name>TOK-001</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          2. Ongoing androgen blockade demonstrated by serum testosterone concentration of less&#xD;
             than 50 ng/dL&#xD;
&#xD;
          3. Demonstration of progression while on androgen blockade&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) Performance Status &lt;2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Depending upon patient prior treatment the following apply:&#xD;
&#xD;
               -  Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone,&#xD;
                  TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone) - Treatment naïve&#xD;
                  only&#xD;
&#xD;
               -  Prior treatment with CYP17 inhibitors (e.g. TAK-700, ketoconazole*) or AR&#xD;
                  antagonists (e.g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory&#xD;
                  only&#xD;
&#xD;
               -  Prior treatment with CYP17 inhibitors (e.g. abiraterone, TAK-700, ketoconazole*)&#xD;
                  or AR antagonists (e.g. ARN -509) or galeterone - enzalutamide refractory only&#xD;
&#xD;
          2. Prior chemotherapy (unless allowed for some study arms)&#xD;
&#xD;
          3. Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment&#xD;
&#xD;
          4. Prior use of any chronic systemic glucocorticoids .&#xD;
&#xD;
          5. Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of&#xD;
             enrollment&#xD;
&#xD;
          6. Prior treatment with Alpharadin® (Xofigo®)&#xD;
&#xD;
          7. Treatment with anti arrhythmia therapy for ventricular arrhythmia &lt; 4 weeks prior to&#xD;
             enrollment&#xD;
&#xD;
          8. Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) &lt; 4 weeks&#xD;
             prior to enrollment&#xD;
&#xD;
          9. Severe systemic diseases or active uncontrolled illnesses.&#xD;
&#xD;
         10. Abnormal heart function&#xD;
&#xD;
         11. Liver metastases&#xD;
&#xD;
         12. Brain metastases (unless stable disease &gt;3 mos. by scan without additional&#xD;
             CNS-directed therapy)&#xD;
&#xD;
         13. The patient has known allergy to any of the treatment components&#xD;
&#xD;
         14. Any physical or mental condition or social situation that in the opinion of the&#xD;
             Investigator may interfere with the patient's ability to comply with the trial&#xD;
             procedures&#xD;
&#xD;
         15. History of excessive alcohol consumption&#xD;
&#xD;
         16. Use of any substance known to cause AME&#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>Bruce Montgomery, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington Seattle Cancer Care Alliance</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mary Ellen Taplin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA David Geffen School of Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-7384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Bernardino Urological Associates</name>
      <address>
        <city>San Bernardino</city>
        <state>California</state>
        <zip>92404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raton Regional Hospital, Lynn Cancer Institute</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane Cancer Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AAHS Research Institute</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Cancer Center and GU Research Network</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Urology Associates</name>
      <address>
        <city>Brick</city>
        <state>New Jersey</state>
        <zip>08724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Urology Associates, LLC</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <zip>08648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Center Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Clinical Trials</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Hospital System University Medical Center</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Clinics of North Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington/Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer Agency</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer CRPC</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>3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene</mesh_term>
  </intervention_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/NCT01709734
org study id: TOK-200-10
nct id: NCT01709734
lead sponsor: 
has dmc: Yes
A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration
      resistant prostate cancer (CRPC) patients.
This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and
      target patient population and Part 2 will be expansion of the dose and patient population
      selected in Part 1. For eligible patients, there will be an optional extension dosing
      following the completion of Part 1 or Part 2 of the trial.

      Obtaining of informed consent and screening may be performed up to 28 days prior to
      enrollment. Each patient will be able to receive his specified regimen for 3 consecutive
      cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit
      assessments will be used to determine outcome and dosing may continue up to an additional 2
      weeks until the results of all assessments are obtained. Eligible patients may continue
      treatment in an optional extension period following the completion of the primary parts of
      this trial.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Confirmation of recommended dose and patient population for Part 2 of the study.
time frame: 3 months
description: Confirmation of recommended dose and patient population for Part 2 of the study.
measure: Assessment of efficacy by means of PSA response.
time frame: 3 months
description: Assessment of efficacy by means of PSA response.
arm group label: Dose Confirmation
arm group type: Experimental
description: Dose A - galeterone tablets once daily PO for three months + extension
Dose B - galeterone tablets once daily PO for three months + extension
Dose C - galeterone tablets once daily PO for three months + extension
arm group label: Dose Expansion
arm group type: Experimental
description: Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension
intervention type: Drug
intervention name: galeterone
arm group label: Dose Confirmation
arm group label: Dose Expansion
other name: TOK-001
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bruce Montgomery, M.D.
role: Principal Investigator
affiliation: University of Washington Seattle Cancer Care Alliance
last name: Mary Ellen Taplin, M.D.
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: 3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene