<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/NCT01692483</url>
  </required_header>
  <id_info>
    <org_study_id>CR100856</org_study_id>
    <secondary_id>212082PCR4003</secondary_id>
    <nct_id>NCT01692483</nct_id>
  </id_info>
  <brief_title>Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Advanced Metastatic Castration Resistant Prostate Cancer</brief_title>
  <official_title>Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in&#xD;
      male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC)&#xD;
      who have received prior chemotherapy containing a taxane.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (identity of assigned study drug will be known), observational study to&#xD;
      evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with&#xD;
      advanced metastatic CRPC who have received prior chemotherapy containing a taxane.&#xD;
      Approximately 50 patients will be enrolled. Abiraterone acetate will be administered&#xD;
      according to the approved product insert with a low-dose glucocorticoid (prednisone or&#xD;
      prednisolone). Patient assessments will be based on the accepted clinical practice in the&#xD;
      Philippines. Patients will be monitored for 40 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor determined study is not required according to PFDA Circular 2013-004&#xD;
  </why_stopped>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants affected by an adverse event</measure>
    <time_frame>Up to 30 days after the last dose of study medication</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with disease progression</measure>
    <time_frame>Baseline up to Week 40</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Neoplasms</condition>
  <arm_group>
    <arm_group_label>Abiraterone acetate plus prednisone</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate</intervention_name>
    <description>Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily</description>
    <arm_group_label>Abiraterone acetate plus prednisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Prednisone or prednisolone 5 mg tablet taken orally twice daily</description>
    <arm_group_label>Abiraterone acetate plus prednisone</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male Filipino patients with advanced metastatic castration resistant prostate cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed adenocarcinoma of the prostate without&#xD;
             neuroendocrine differentiation or small cell histology&#xD;
&#xD;
          -  Received at least 1 but not more than 2 cytotoxic chemotherapy regimens for metastatic&#xD;
             castration resistant prostate cancer (CRPC) (at least 1 regimen must have contained a&#xD;
             taxane such as docetaxel; if a chemotherapy regimen containing a taxane is used more&#xD;
             than once, this will be considered as 1 regimen)&#xD;
&#xD;
          -  Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
          -  Laboratory values within protocol -defined parameters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious or uncontrolled co-existent non-malignant disease, including active and&#xD;
             uncontrolled infection&#xD;
&#xD;
          -  Abnormal liver function&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure &gt;=160 mmHg or diastolic blood&#xD;
             pressure &gt;=95 mmHg)&#xD;
&#xD;
          -  Active or symptomatic viral hepatitis or chronic liver disease&#xD;
&#xD;
          -  History of pituitary or adrenal dysfunction&#xD;
&#xD;
          -  Clinically significant heart disease as evidenced by myocardial infarction, or&#xD;
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New&#xD;
             York Heart Association (NYHA) Class III or IV heart disease or left ventricular&#xD;
             ejection fraction of &lt;50% at baseline&#xD;
&#xD;
          -  Known brain metastasis&#xD;
&#xD;
          -  History of gastrointestinal disorders (medical disorders or extensive surgery) that&#xD;
             may interfere with the absorption of the study drug&#xD;
&#xD;
          -  Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved&#xD;
             to a NCI-CTCAE (Version 4.0) Grade of &lt;=1&#xD;
&#xD;
          -  Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole,&#xD;
             ketoconazole) within 4 weeks of Cycle 1, Day 1&#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;
&#xD;
          -  Participation in an investigational drug trial within 30 days prior to selection&#xD;
&#xD;
          -  Known hypersensitivity to abiraterone acetate, or to any of the components in the&#xD;
             formulation&#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>is Janssen Pharmaceutica, Philippines Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica, Philippines</affiliation>
  </overall_official>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate neoplasms</keyword>
  <keyword>Prostate cancer</keyword>
  <keyword>Castration resistant prostate cancer</keyword>
  <keyword>Hormone refractory prostate cancer</keyword>
  <keyword>Abiraterone acetate</keyword>
  <keyword>Taxane</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>Prednisone</mesh_term>
    <mesh_term>Abiraterone Acetate</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/NCT01692483
org study id: CR100856
secondary id: 212082PCR4003
nct id: NCT01692483
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in
      male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC)
      who have received prior chemotherapy containing a taxane.
This is an open-label (identity of assigned study drug will be known), observational study to
      evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with
      advanced metastatic CRPC who have received prior chemotherapy containing a taxane.
      Approximately 50 patients will be enrolled. Abiraterone acetate will be administered
      according to the approved product insert with a low-dose glucocorticoid (prednisone or
      prednisolone). Patient assessments will be based on the accepted clinical practice in the
      Philippines. Patients will be monitored for 40 weeks.
observational model: Cohort
time perspective: Prospective
measure: Number of participants affected by an adverse event
time frame: Up to 30 days after the last dose of study medication
measure: Number of patients with disease progression
time frame: Baseline up to Week 40
arm group label: Abiraterone acetate plus prednisone
intervention type: Drug
intervention name: Abiraterone acetate
description: Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
arm group label: Abiraterone acetate plus prednisone
intervention type: Drug
intervention name: Prednisone
description: Prednisone or prednisolone 5 mg tablet taken orally twice daily
arm group label: Abiraterone acetate plus prednisone
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: is Janssen Pharmaceutica, Philippines Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica, Philippines
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Abiraterone Acetate