<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/NCT01664728</url>
  </required_header>
  <id_info>
    <org_study_id>CR016912</org_study_id>
    <secondary_id>COU-AA-001EXT</secondary_id>
    <secondary_id>2006-006755-12</secondary_id>
    <nct_id>NCT01664728</nct_id>
  </id_info>
  <brief_title>An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001</brief_title>
  <official_title>An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to provide access to abiraterone acetate for patients who have&#xD;
      completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and&#xD;
      continue to receive clinical benefit from this treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (identity of study drug will be known) extended access study to&#xD;
      evaluate the safety and efficacy of continued administration of abiraterone acetate in&#xD;
      patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study&#xD;
      COU-AA-001 and continue to receive clinical benefit from this treatment. Patients will&#xD;
      continue with the same dose regimen administered at the end of Study COU-AA-001 and will&#xD;
      receive a low-dose glucocorticoid daily. Patients will be followed every 3 months for disease&#xD;
      progression and survival for up to 3 years following study entry. Safety will be monitored&#xD;
      throughout the study up to 30 days after the last dose of study medication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2007</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">February 2009</primary_completion_date>
  <phase>Phase 1</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>Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria</measure>
    <time_frame>Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>every 3 months up to 3 years after study entry</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>up to 30 days after the last dose of study medication</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to disease progression</measure>
    <time_frame>every 3 months up to 3 years after study entry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to prostate specific antigen progression</measure>
    <time_frame>every 3 months up to 3 years after study entry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)</measure>
    <time_frame>every 3 months up to 3 years after study entry</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Prostate Neoplasms</condition>
  <arm_group>
    <arm_group_label>Abiraterone acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate</intervention_name>
    <description>Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily</description>
    <arm_group_label>Abiraterone acetate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucocorticoid</intervention_name>
    <description>prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily</description>
    <arm_group_label>Abiraterone acetate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completed 12 cycles of abiraterone acetate under study COU-AA-001&#xD;
&#xD;
          -  Last dose of abiraterone acetate within 14 days prior to treatment in this study&#xD;
&#xD;
          -  Demonstrates potential to gain clinical benefit with continued abiraterone acetate&#xD;
             treatment&#xD;
&#xD;
          -  Serum potassium level &gt;=3.5 mmol/L&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group Performance Status of &lt;3 (Karnofsky Performance&#xD;
             Status &gt;=30%)&#xD;
&#xD;
          -  Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious or uncontrolled co-existent non-malignant disease, including active and&#xD;
             uncontrolled infection&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Abnormal liver function&#xD;
&#xD;
          -  Clinically significant heart disease as evidenced by a myocardial infarction in the&#xD;
             past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class&#xD;
             III or IV heart disease (patients with a history of atherosclerotic vascular disease&#xD;
             requiring coronary or peripheral artery bypass surgery may be enrolled provided the&#xD;
             surgery occurred at least 2 years prior to enrollment and after consultation with a&#xD;
             cardiologist to insure that the disease is stable)&#xD;
&#xD;
          -  Condition or situation which, in the investigator's opinion, may put the patient at&#xD;
             significant risk, may confound the study results, or may interfere significantly with&#xD;
             patient's participation in the study&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Sutton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&amp;studyid=2388&amp;filename=CR016912_CSR.pdf</url>
    <description>An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001</description>
  </link>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>April 18, 2013</last_update_submitted>
  <last_update_submitted_qc>April 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate neoplasms</keyword>
  <keyword>Hormone refractory prostate cancer</keyword>
  <keyword>Castration resistant prostate cancer</keyword>
  <keyword>Castration refractory prostate cancer</keyword>
  <keyword>Abiraterone acetate</keyword>
  <keyword>CB7630</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>Abiraterone Acetate</mesh_term>
    <mesh_term>Glucocorticoids</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/NCT01664728
org study id: CR016912
secondary id: COU-AA-001EXT
secondary id: 2006-006755-12
nct id: NCT01664728
lead sponsor: 
has dmc: No
The purpose of this study is to provide access to abiraterone acetate for patients who have
      completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and
      continue to receive clinical benefit from this treatment.
This is an open-label (identity of study drug will be known) extended access study to
      evaluate the safety and efficacy of continued administration of abiraterone acetate in
      patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study
      COU-AA-001 and continue to receive clinical benefit from this treatment. Patients will
      continue with the same dose regimen administered at the end of Study COU-AA-001 and will
      receive a low-dose glucocorticoid daily. Patients will be followed every 3 months for disease
      progression and survival for up to 3 years following study entry. Safety will be monitored
      throughout the study up to 30 days after the last dose of study medication.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria
time frame: Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry
measure: Overall survival
time frame: every 3 months up to 3 years after study entry
measure: Number of participants with adverse events
time frame: up to 30 days after the last dose of study medication
measure: Time to disease progression
time frame: every 3 months up to 3 years after study entry
measure: Time to prostate specific antigen progression
time frame: every 3 months up to 3 years after study entry
measure: Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: every 3 months up to 3 years after study entry
arm group label: Abiraterone acetate
arm group type: Experimental
intervention type: Drug
intervention name: Abiraterone acetate
description: Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily
arm group label: Abiraterone acetate
intervention type: Drug
intervention name: Glucocorticoid
description: prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily
arm group label: Abiraterone acetate
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: United Kingdom
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2388&filename=CR016912_CSR.pdf
description: An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Abiraterone Acetate
mesh term: Glucocorticoids