<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/NCT01663415</url>
  </required_header>
  <id_info>
    <org_study_id>9785-UC-0001</org_study_id>
    <nct_id>NCT01663415</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer</brief_title>
  <official_title>A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medivation, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate radiographic progression-free survival (PFS) of&#xD;
      enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant&#xD;
      prostate cancer who have symptomatic disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    A business decision was made to not initiate this study.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>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>Radiographic progression free survival (PFS)</measure>
    <time_frame>26 months</time_frame>
    <description>Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>26 months</time_frame>
    <description>Time from first dose on Day 1 to death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to PSA progression</measure>
    <time_frame>26 months</time_frame>
    <description>Time from first dose on Day 1 to first observation of PSA progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)</measure>
    <time_frame>Baseline and 26 months</time_frame>
    <description>The FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D)</measure>
    <time_frame>Baseline and 26 months</time_frame>
    <description>EQ-5D is a standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status and is designed for self-completion by respondents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)</measure>
    <time_frame>Baseline and 26 months</time_frame>
    <description>Brief Pain Inventory is a validated instrument that is a subject self-rating scale assessing level of pain, effect of the pain on activities of daily living, and analgesic use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs)</measure>
    <time_frame>26 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Metastatic Castration-Resistant Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Enzalutamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>oral</description>
    <arm_group_label>Enzalutamide</arm_group_label>
    <other_name>MDV3100</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Progressive prostate cancer while on androgen deprivation therapy&#xD;
&#xD;
          -  Castrate testosterone level&#xD;
&#xD;
          -  Maintenance of surgical or medical castration for duration of study&#xD;
&#xD;
          -  Radiographically visible metastatic disease&#xD;
&#xD;
          -  Symptomatic from prostate cancer&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) 0-2&#xD;
&#xD;
          -  Life expectancy &gt;=6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain metastases or leptomeningeal disease&#xD;
&#xD;
          -  Prior cytotoxic chemotherapy for prostate cancer&#xD;
&#xD;
          -  Prior use of ketoconazole or abiraterone acetate or other investigational agent that&#xD;
             blocks androgen synthesis or targets androgen receptor&#xD;
&#xD;
          -  History of seizure or condition that may predispose to seizure&#xD;
&#xD;
          -  History of loss of consciousness or transient ischemic attack within 12 months&#xD;
&#xD;
          -  Clinically significant cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senior Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>September 14, 2012</last_update_submitted>
  <last_update_submitted_qc>September 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MDV3100</keyword>
  <keyword>prostate</keyword>
  <keyword>cancer</keyword>
  <keyword>enzalutamide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT01663415
org study id: 9785-UC-0001
nct id: NCT01663415
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate radiographic progression-free survival (PFS) of
      enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant
      prostate cancer who have symptomatic disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Radiographic progression free survival (PFS)
time frame: 26 months
description: Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2).
measure: Overall survival
time frame: 26 months
description: Time from first dose on Day 1 to death due to any cause
measure: Time to PSA progression
time frame: 26 months
description: Time from first dose on Day 1 to first observation of PSA progression
measure: Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)
time frame: Baseline and 26 months
description: The FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer patients
measure: Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D)
time frame: Baseline and 26 months
description: EQ-5D is a standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status and is designed for self-completion by respondents
measure: Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)
time frame: Baseline and 26 months
description: Brief Pain Inventory is a validated instrument that is a subject self-rating scale assessing level of pain, effect of the pain on activities of daily living, and analgesic use
measure: Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs)
time frame: 26 months
arm group label: Enzalutamide
arm group type: Experimental
intervention type: Drug
intervention name: Enzalutamide
description: oral
arm group label: Enzalutamide
other name: MDV3100
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Senior Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms