<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/NCT04421963</url>
  </required_header>
  <id_info>
    <org_study_id>D0817C00098</org_study_id>
    <secondary_id>2019-003777-26</secondary_id>
    <nct_id>NCT04421963</nct_id>
  </id_info>
  <brief_title>Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib</brief_title>
  <acronym>ROSY-O</acronym>
  <official_title>Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rationale of the ROSY-O study is to continue to provide study treatment for patients who&#xD;
      have participated in a parent study with olaparib and who are continuing to derive clinical&#xD;
      benefit from treatment at the end of such studies, as judged by the Investigator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ROSY-O is an open label, non-randomised, multicentre,international trial for patients who&#xD;
      have completed a parent study using olaparib and who are deriving clinical benefit from&#xD;
      continued treatment as judged by the Investigator. Patients will be rolled-over from the&#xD;
      parent study and will continue the study indefinitely, until they meet one of the treatment&#xD;
      discontinuation criteria&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Anticipated">January 8, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 8, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety follow up</measure>
    <time_frame>Baseline up to approximately 10 years</time_frame>
    <description>Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">292</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Olaparib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>300 mg olaparib (2×150 mg tablets) twice daily</description>
    <arm_group_label>Olaparib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated, written ICF.&#xD;
&#xD;
          2. Patient is currently deriving clinical benefit, as judged by the Investigator, from&#xD;
             continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has&#xD;
             met its endpoints or has otherwise stopped.&#xD;
&#xD;
          3. Patient participating in a prior oncology study with an AZ compound in which they&#xD;
             received olaparib and are continuing to receive clinical benefit from treatment; the&#xD;
             prior study can be an open-label or blinded study, with unblinding at study close.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at&#xD;
             the time of the termination of the parent study.&#xD;
&#xD;
          2. Currently receiving treatment with any prohibited medication(s).&#xD;
&#xD;
          3. Concurrently enrolled in any other type of medical research judged not to be&#xD;
             scientifically or medically compatible with this study.&#xD;
&#xD;
          4. Permanent discontinuation from the parent study due to toxicity or disease&#xD;
             progression.&#xD;
&#xD;
          5. Local access to commercially-available drug at no cost to the patient is permitted by&#xD;
             local regulation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female subjects with historically diagnosed relapsed high grade serious or high grade endometrioid ovarian cancer; Patients with HER2-ve metastatic breast cancer with germline or somatic BRCA mutations.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Hollywood</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
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        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
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        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
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        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>3000</zip>
        <country>Belgium</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
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        <zip>22793-080</zip>
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  <location>
    <facility>
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        <city>Sofia</city>
        <zip>1330</zip>
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    </facility>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
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        <state>Ontario</state>
        <zip>K7L 2V7</zip>
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  <location>
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      <name>Research Site</name>
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        <state>Ontario</state>
        <zip>L5M 2N1</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A-3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1S 4L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
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  <location>
    <facility>
      <name>Research Site</name>
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        <zip>625 00</zip>
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  <location>
    <facility>
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        <zip>656 53</zip>
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  <location>
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      <name>Research Site</name>
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        <zip>779 00</zip>
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  <location>
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      <name>Research Site</name>
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      <name>Research Site</name>
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  <location>
    <facility>
      <name>Research Site</name>
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  <location>
    <facility>
      <name>Research Site</name>
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        <zip>69373</zip>
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  <location>
    <facility>
      <name>Research Site</name>
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  <location>
    <facility>
      <name>Research Site</name>
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        <zip>94800</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>1307</zip>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>1032</zip>
        <country>Hungary</country>
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  <location>
    <facility>
      <name>Research Site</name>
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      <name>Research Site</name>
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    <facility>
      <name>Research Site</name>
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    <facility>
      <name>Research Site</name>
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        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>6351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Białystok</city>
        <zip>15-027</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grzepnica</city>
        <zip>72-003</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-561</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznan</city>
        <zip>61-866</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznań</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orenburg</city>
        <zip>460021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sankt-Peterburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <zip>8907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <zip>?08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sahinbey</city>
        <zip>27310</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B18 7QH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 OYN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hull</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taunton</city>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HER2-ve metastatic</keyword>
  <keyword>BRCA mutations</keyword>
  <keyword>Cancer</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olaparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <!-- 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/NCT04421963
org study id: D0817C00098
secondary id: 2019-003777-26
nct id: NCT04421963
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The rationale of the ROSY-O study is to continue to provide study treatment for patients who
      have participated in a parent study with olaparib and who are continuing to derive clinical
      benefit from treatment at the end of such studies, as judged by the Investigator.
ROSY-O is an open label, non-randomised, multicentre,international trial for patients who
      have completed a parent study using olaparib and who are deriving clinical benefit from
      continued treatment as judged by the Investigator. Patients will be rolled-over from the
      parent study and will continue the study indefinitely, until they meet one of the treatment
      discontinuation criteria
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety follow up
time frame: Baseline up to approximately 10 years
description: Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.
arm group label: Olaparib
arm group type: Experimental
description: Treatment
intervention type: Drug
intervention name: Olaparib
description: 300 mg olaparib (2×150 mg tablets) twice daily
arm group label: Olaparib
criteria: 
gender: All
gender based: Yes
gender description: Female subjects with historically diagnosed relapsed high grade serious or high grade endometrioid ovarian cancer; Patients with HER2-ve metastatic breast cancer with germline or somatic BRCA mutations.
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
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country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: China
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Korea, Republic of
country: Poland
country: Portugal
country: Russian Federation
country: Slovenia
country: Spain
country: Sweden
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Olaparib
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home