<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/NCT02262273</url>
  </required_header>
  <id_info>
    <org_study_id>D0816R00004</org_study_id>
    <nct_id>NCT02262273</nct_id>
  </id_info>
  <brief_title>OSCA - Olaparib Standard of CAre Study</brief_title>
  <acronym>OSCA</acronym>
  <official_title>Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RTI Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>A+A Healthcare Marketing Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Freelance CRA (FCRA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be carried out as a retrospective, non-interventional observational review of&#xD;
      medical records for patients in multiple countries with platinum-sensitive recurrent serous&#xD;
      ovarian cancer. The objectives are to describe in a real-world population, treatment&#xD;
      patterns, BRCA mutation testing and results, overall survival, health care utilization and&#xD;
      also to estimate rates of selected treatment- and/or disease-related side effects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Best response to therapy and date of response for each subsequent therapy line post-index</measure>
    <time_frame>Data will be collected retrospectively from medical records</time_frame>
    <description>Response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) Criteria on which physicians determined therapy response also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival, by therapy line</measure>
    <time_frame>Data will be collected retrospectively from medical records</time_frame>
    <description>Defined as time from initiation of the therapy line (including the required first-line platinum-based chemotherapy) until the earliest of progression, death, or end of follow-up (for censored observations) Criteria on which physicians determined progression also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival, calculated from various time points</measure>
    <time_frame>Data will be collected retrospectively from medical records</time_frame>
    <description>From first diagnosis of ovarian cancer until death or end of follow-up, whichever is earliest From initiation of the required first-line platinum-based chemotherapy regimen until death or end of follow-up, whichever is earliest From the index date (first determination of platinum-sensitive recurrence) until death or end of follow-up, whichever is earliest From initiation of each subsequent, post-index therapy line until death or end of follow-up, whichever is earliest</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2123</enrollment>
  <condition>Platinum-sensitive Recurrent Serous Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Serous ovarian cancer:</arm_group_label>
    <description>Women with platinum-sensitive recurrent serous ovarian cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data Collection</intervention_name>
    <description>Colleciton of data from medical records only</description>
    <arm_group_label>Serous ovarian cancer:</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        platinum-sensitive recurrent serous ovarian cancer patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. First determined to have platinum-sensitive recurrent serous ovarian cancer between&#xD;
             January 1, 2009, and December 31, 2013 (study entry period), as defined by no evidence&#xD;
             of disease progression for at least 6 months after completion of a first-line&#xD;
             platinum-based chemotherapy regimen; the first date of platinum-sensitive recurrence&#xD;
             between January 1, 2009 and December 31, 2013 will define the study index date.&#xD;
&#xD;
          2. At least 18 years of age on the index date.&#xD;
&#xD;
          3. Fully documented medical history related to the patient's ovarian cancer treatment&#xD;
             beginning with initial diagnosis of serous ovarian cancer.&#xD;
&#xD;
          4. Patients can be either alive or deceased at the time of medical record abstraction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Ever taken an investigational product as part of an interventional clinical trial for&#xD;
        ovarian cancer.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicoletta Colombo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Steering Committee/Advisory Board Members</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laurence Gladieff, MD</last_name>
    <role>Study Director</role>
    <affiliation>Steering Committee/Advisory Board Members</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sven Mahner, MD</last_name>
    <role>Study Director</role>
    <affiliation>Steering Committee/Advisory Board Members</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isabel Bover, MD</last_name>
    <role>Study Director</role>
    <affiliation>Steering Committee/Advisory Board Members</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacob Korach, MD</last_name>
    <role>Study Director</role>
    <affiliation>Steering Committee/Advisory Board Members</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ballarat</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birtinya</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Campbelltown</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>East Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mandurah, Western Australia</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>South Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Leonards</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Victoria</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Waratah</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Namur</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sint-Niklaas</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alberta</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charlottetown</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mississauga</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ottawa</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Red Deer</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aix En Provence</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ajaccio</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Auxerre</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Besancon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beziers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bourg-en-bresse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chambery</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colombes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Libourne Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Longjumeau</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mont de Marsan</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montbeliard</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Narbonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quimper</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rennes Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Pierre Du Mont</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tours Cedex 9</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bonn Bad Godesberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chemnitz</city>
        <country>Germany</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dusseldorf</city>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Frankfurt am Main</city>
        <country>Germany</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hagen</city>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Heilbronn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Karlsruhe</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Koln</city>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kothen</city>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leverkusen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Munchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nurnberg</city>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osnabruck</city>
        <country>Germany</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Passau</city>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ratingen</city>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saarlouis</city>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Velbert</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wetzlar</city>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Afula</city>
        <country>Israel</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Petah Tikva</city>
        <country>Israel</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rehovot</city>
        <country>Israel</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St. Holon</city>
        <country>Israel</country>
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  <location>
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      <address>
        <city>Taunton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wales</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wolverhampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
  </removed_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=2941&amp;filename=D0816R00004_CSR_Synopsis_23Feb2017.pdf</url>
    <description>D0816R00004_CSR_Synopsis_23Feb2017.pdf</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>February 28, 2017</last_update_submitted>
  <last_update_submitted_qc>February 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>women</keyword>
  <keyword>platinum sensitive</keyword>
  <keyword>recurrent</keyword>
  <keyword>serous</keyword>
  <keyword>ovarian cancer</keyword>
  <keyword>BRCA</keyword>
  <keyword>PARP</keyword>
  <keyword>Olaparib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Recurrence</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/NCT02262273
org study id: D0816R00004
nct id: NCT02262273
lead sponsor: 
collaborator: 
collaborator: 
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has dmc: No
This study will be carried out as a retrospective, non-interventional observational review of
      medical records for patients in multiple countries with platinum-sensitive recurrent serous
      ovarian cancer. The objectives are to describe in a real-world population, treatment
      patterns, BRCA mutation testing and results, overall survival, health care utilization and
      also to estimate rates of selected treatment- and/or disease-related side effects
observational model: Cohort
time perspective: Retrospective
measure: Best response to therapy and date of response for each subsequent therapy line post-index
time frame: Data will be collected retrospectively from medical records
description: Response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) Criteria on which physicians determined therapy response also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria).
measure: Progression-free survival, by therapy line
time frame: Data will be collected retrospectively from medical records
description: Defined as time from initiation of the therapy line (including the required first-line platinum-based chemotherapy) until the earliest of progression, death, or end of follow-up (for censored observations) Criteria on which physicians determined progression also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria)
measure: Overall survival, calculated from various time points
time frame: Data will be collected retrospectively from medical records
description: From first diagnosis of ovarian cancer until death or end of follow-up, whichever is earliest From initiation of the required first-line platinum-based chemotherapy regimen until death or end of follow-up, whichever is earliest From the index date (first determination of platinum-sensitive recurrence) until death or end of follow-up, whichever is earliest From initiation of each subsequent, post-index therapy line until death or end of follow-up, whichever is earliest
arm group label: Serous ovarian cancer:
description: Women with platinum-sensitive recurrent serous ovarian cancer
intervention type: Other
intervention name: Data Collection
description: Colleciton of data from medical records only
arm group label: Serous ovarian cancer:
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicoletta Colombo, MD
role: Study Director
affiliation: Steering Committee/Advisory Board Members
last name: Laurence Gladieff, MD
role: Study Director
affiliation: Steering Committee/Advisory Board Members
last name: Sven Mahner, MD
role: Study Director
affiliation: Steering Committee/Advisory Board Members
last name: Isabel Bover, MD
role: Study Director
affiliation: Steering Committee/Advisory Board Members
last name: Jacob Korach, MD
role: Study Director
affiliation: Steering Committee/Advisory Board Members
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country: Australia
country: Belgium
country: Canada
country: France
country: Germany
country: Israel
country: Italy
country: Korea, Republic of
country: Netherlands
country: Portugal
country: Spain
country: Switzerland
country: United Kingdom
country: Austria
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2941&filename=D0816R00004_CSR_Synopsis_23Feb2017.pdf
description: D0816R00004_CSR_Synopsis_23Feb2017.pdf
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Hypersensitivity
mesh term: Recurrence