<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/NCT03759600</url>
  </required_header>
  <id_info>
    <org_study_id>Niraparib-2002</org_study_id>
    <secondary_id>U1111-1222-4100</secondary_id>
    <secondary_id>JapicCTI-184224</secondary_id>
    <nct_id>NCT03759600</nct_id>
  </id_info>
  <brief_title>Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer</brief_title>
  <official_title>A Phase 2, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Niraparib in Japanese Patients With Advanced, Relapsed, High-grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received 3 or 4 Previous Chemotherapy Regimens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of niraparib in participants&#xD;
      with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary&#xD;
      peritoneal cancer who have received 3 or 4 previous chemotherapy regimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called niraparib. Niraparib is being tested to treat&#xD;
      people who have the homologous recombination deficiency (HRD)-positive, advanced, relapsed,&#xD;
      high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This&#xD;
      study will look at the efficacy and safety of niraparib in Japanese participants.&#xD;
&#xD;
      The study will enroll approximately 16 participants. Participants will be enrolled to one&#xD;
      group and after that will be asked to take niraparib capsules at the same time each day&#xD;
      throughout the study:&#xD;
&#xD;
      - Niraparib 300 mg&#xD;
&#xD;
      This multi-center trial will be conducted in Japan. The overall time to participate in this&#xD;
      study is approximately 23 months. Participants will make multiple visits to the clinic in the&#xD;
      treatment period, and the post-treatment period including follow-up assessments after the&#xD;
      last dose of the study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 26, 2018</start_date>
  <completion_date type="Actual">December 28, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>Objective Response Rate (ORR)</measure>
    <time_frame>Until disease progression, death or data cut-off (Up to approximately 5 months)</time_frame>
    <description>ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Until disease progression, death or data cut-off (Up to approximately 5 months)</time_frame>
    <description>DOR was defined as the time from the first documented CR or PR per RECIST v. 1.1 to disease recurrence or objective disease progression whichever occurs first. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>Until disease progression, death or data cut-off (Up to approximately 5 months)</time_frame>
    <description>DCR was defined as the percentage of participants achieving CR, PR or Stable Disease (SD) as assessed by the Investigator per RECIST v. 1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3 or Higher TEAEs</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious TEAEs</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. An SAE was any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Leading to Drug Discontinuation</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Leading to Dose Interruption</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Leading to Dose Reduction</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Until disease progression, death or data cut-off (Up to approximately 5 months)</time_frame>
    <description>PFS was defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the RECIST version 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to data cut-off approximately 6 months</time_frame>
    <description>OS was defined as the time in months from the study enrollment to death due to any cause.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Primary Peritoneal Cancer</condition>
  <arm_group>
    <arm_group_label>Niraparib 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1 - 28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib</intervention_name>
    <description>Niraparib capsule</description>
    <arm_group_label>Niraparib 300 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Japanese female participants aged 20 years or older on the day of signing informed&#xD;
             consent.&#xD;
&#xD;
          2. Voluntary written consent must be given before performance of any study related&#xD;
             procedure not part of standard medical care, with the understanding that consent may&#xD;
             be withdrawn by the participant at any time without prejudice to future medical care.&#xD;
&#xD;
          3. Participants must agree to undergo tumor homologous recombination deficiency/deficient&#xD;
             (HRD) testing, and this test result must show that participants have an HRD-positive&#xD;
             tumor (defined by the presence of a deleterious or suspected deleterious breast cancer&#xD;
             gene (BRCA) mutation or be positive for genomic instability) by the central laboratory&#xD;
             selected by the sponsor.&#xD;
&#xD;
             Note 1: The study HRD test result must be received prior to enrollment. The tumor&#xD;
             sample may be submitted for HRD testing prior to the screening period (ie, within 40&#xD;
             days before Cycle 1 Day 1) if the consent has been obtained and it appears the&#xD;
             participant is likely to meet other eligibility requirements.&#xD;
&#xD;
             Note 2: If historic blood germline BRCA mutation (gBRCAmut) is detected by a prior&#xD;
             gBRCAmut testing, then tumor HRD sample test results are not required prior to&#xD;
             enrollment; however, HRD testing still needs to be performed.&#xD;
&#xD;
          4. Participants must have histologically diagnosed, relapsed, high-grade (Grade 2 or 3)&#xD;
             serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent&#xD;
             disease and must have been previously treated with chemotherapy and have not&#xD;
             experienced disease progression at least 6 months to the last chemotherapy containing&#xD;
             platinum-based anticancer agents.&#xD;
&#xD;
          5. Participants must have completed 3 or 4 previous chemotherapy regimens. Participants&#xD;
             must have completed their last chemotherapy regimen &gt;4 weeks prior to treatment&#xD;
             initiation.&#xD;
&#xD;
          6. Participants must have at least one measurable disease according to Response&#xD;
             Evaluation Criteria in Solid Tumors (RECIST) (v.1.1).&#xD;
&#xD;
          7. Participants must have performance status of ≤1 on the Eastern Cooperative Oncology&#xD;
             Group (ECOG) Performance Status Scale.&#xD;
&#xD;
          8. Participants must have adequate organ function as indicated by the following&#xD;
             laboratory values:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥1,500/μL.&#xD;
&#xD;
               -  Platelet count ≥150,000/μL.&#xD;
&#xD;
               -  Hemoglobin ≥10 g/dL.&#xD;
&#xD;
               -  Serum creatinine ≤1.5× institutional upper limit of normal (ULN) OR calculated&#xD;
                  creatinine clearance ≥50 mL/minute, using the Cockcroft-Gault equation.&#xD;
&#xD;
               -  Total bilirubin ≤1.5×ULN OR direct bilirubin ≤1×ULN.&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN&#xD;
                  unless liver metastases were present, in which case they had to be ≤5×ULN.&#xD;
&#xD;
          9. Participants must have formalin-fixed, paraffin-embedded tumor samples available from&#xD;
             the primary or recurrent cancer or agree to undergo fresh biopsy prior to study&#xD;
             treatment initiation.&#xD;
&#xD;
         10. Participants must be able to take oral medications.&#xD;
&#xD;
         11. Female participants of childbearing potential must be negative for pregnancy test&#xD;
             (beta-human chorionic gonadotropin [β-hCG]) within 7 days prior to receiving the first&#xD;
             dose of study treatment.&#xD;
&#xD;
         12. Female participants who:&#xD;
&#xD;
               -  Are postmenopausal for at least 1 year before the screening visit, OR&#xD;
&#xD;
               -  Are surgically sterile, OR&#xD;
&#xD;
               -  If they are of childbearing potential, agree to practice 1 highly effective&#xD;
                  method of contraception and 1 additional effective (barrier) method at the same&#xD;
                  time, from the time of signing the informed consent through 180 days after the&#xD;
                  last dose of study drug, OR&#xD;
&#xD;
               -  Agree to practice true abstinence, when this is in line with the preferred and&#xD;
                  usual lifestyle of the participant. (Periodic abstinence [eg, calendar,&#xD;
                  ovulation, symptothermal, postovulation methods], condoms only, withdrawal,&#xD;
                  spermicides only, and lactational amenorrhea are not acceptable methods of&#xD;
                  contraception. Female and male condoms should not be used together.)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Participants who have had palliative radiotherapy encompassing &gt;20% of the bone marrow&#xD;
             within 1 week of the first dose of study treatment.&#xD;
&#xD;
          2. Participants who have any known, persistent (&gt;4 weeks), Grade ≥3 hematologic toxicity&#xD;
             from last cancer therapy.&#xD;
&#xD;
          3. Participants who have any known, persistent (&gt;4 weeks), Grade ≥3 fatigue during the&#xD;
             last cancer therapy.&#xD;
&#xD;
          4. Participants who have received pelvic radiotherapy as treatment for primary or&#xD;
             recurrent disease within 1 year of the first dose of study treatment.&#xD;
&#xD;
          5. Participants who have symptomatic, uncontrolled brain or leptomeningeal metastases.&#xD;
&#xD;
             To be considered &quot;controlled,&quot; central nervous system (CNS) disease must have&#xD;
             undergone treatment (eg, radiation or chemotherapy) at least 1 month prior to study&#xD;
             enrollment. The participant must not have had any new or progressive signs or symptoms&#xD;
             related to the CNS disease and must have been taking a stable dose of steroids or no&#xD;
             steroids (as long as these were started at least 4 weeks prior to enrollment] or no&#xD;
             steroids). A scan to confirm the absence of brain metastases at baseline was not&#xD;
             required. Participants with spinal cord compression might have been considered if they&#xD;
             had received definitive treatment for this and evidence of clinically stable disease&#xD;
             for 28 days.&#xD;
&#xD;
          6. Participants who have known hypersensitivity to the components of niraparib.&#xD;
&#xD;
          7. Participants who have had prior treatment with a known poly (adenosine diphosphate&#xD;
             [ADP]-ribose) polymerase (PARP) inhibitors.&#xD;
&#xD;
          8. Participant who have had treatment with any investigational products within 28 days or&#xD;
             5 half-lives (whichever was longer) before the first dose.&#xD;
&#xD;
          9. Participants who have had major surgery per Investigator judgment within 3 weeks of&#xD;
             the first dose. Participant must have recovered from any effects of any major surgery.&#xD;
&#xD;
         10. Participants who have diagnosis, detection, or treatment of invasive second primary&#xD;
             malignancy other than ovarian cancer ≤24 months prior to study enrollment (except&#xD;
             basal or squamous cell carcinoma of the skin that was definitively treated). Note:&#xD;
             Participants must not have any known history or current diagnosis of myelodysplastic&#xD;
             syndrome (MDS) or acute myeloid leukemia (AML), irrespective of the time for disease&#xD;
             history.&#xD;
&#xD;
         11. Participants who are considered a poor medical risk due to a serious, uncontrolled&#xD;
             medical disorder, non-malignant systemic disease, or active, uncontrolled infection.&#xD;
             Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent&#xD;
             (within 90 days of the first dose) myocardial infarction, uncontrolled major seizure&#xD;
             disorder, unstable spinal cord compression, superior vena cava syndrome, small bowel&#xD;
             obstruction or other serious gastrointestinal disorder, or any psychiatric disorder&#xD;
             that prohibits obtaining informed consent.&#xD;
&#xD;
         12. Participants who have received a transfusion (platelets or red blood cells) within 4&#xD;
             weeks of the first dose of study treatment.&#xD;
&#xD;
         13. Participants who have received a live virus or bacterial vaccines within 4 weeks of&#xD;
             the first dose of study treatment.&#xD;
&#xD;
         14. Participants who have a history or current evidence of any condition, therapy, or lab&#xD;
             abnormality (including active or uncontrolled myelosuppression [ie, anemia,&#xD;
             leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the&#xD;
             study, interfere with the participant's participation throughout the study period, or&#xD;
             study participation is not in the best interest of the participant.&#xD;
&#xD;
         15. Participants who are regular user (including &quot;recreational use&quot;) of any illicit drugs&#xD;
             at the time of signing informed consent or have a recent history (within the past&#xD;
             year) of drug or alcohol abuse.&#xD;
&#xD;
         16. Participants who are pregnant or breast-feeding or expecting to conceive within the&#xD;
             planned duration of the study.&#xD;
&#xD;
             NOTE: If a breast-feeding woman discontinue breast-feeding, she may be enrolled in the&#xD;
             study.&#xD;
&#xD;
         17. Participants who are immunocompromised (participants with splenectomy are allowed).&#xD;
&#xD;
         18. Participants who have known human immunodeficiency virus (HIV) positive.&#xD;
&#xD;
         19. Participants who have known hepatitis B surface antigen (HBsAg) positive, or known or&#xD;
             suspected active hepatitis C virus (HCV) infection.&#xD;
&#xD;
        NOTE: Participants who are positive for hepatitis B core antibody (HBcAb) or hepatitis B&#xD;
        surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B virus&#xD;
        (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) must&#xD;
        have an undetectable HCV viral load.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 previous chemotherapy regimens.</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirosaki University Hospital</name>
      <address>
        <city>Hirosaki</city>
        <state>Aomori</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jikei University Kashiwa Hospital</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital</name>
      <address>
        <city>Toon</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kure Medical Center and Chugoku Cancer Center</name>
      <address>
        <city>Kure</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center</name>
      <address>
        <city>Akashi</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Rosai Hospital</name>
      <address>
        <city>Amagasaki</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Isehara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Musashi Kosugi Hospital</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital</name>
      <address>
        <city>Tsu</city>
        <state>Mie</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of the Ryukyus Hospital</name>
      <address>
        <city>Nakagami-gun</city>
        <state>Okinawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Hidaka</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Nagaizumi-cho</city>
        <state>Shizuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Institute Hospital</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jikei University Hospital</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Omori Medical Center</name>
      <address>
        <city>Ota-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba University Hospital</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu University Hospital</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima City Hospital</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical &amp; Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>June 30, 2020</results_first_submitted>
  <results_first_submitted_qc>July 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 11, 2020</results_first_posted>
  <last_update_submitted>January 15, 2023</last_update_submitted>
  <last_update_submitted_qc>January 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niraparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03759600/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03759600/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 17 investigative sites in Japan from 26 December 2018 to data cut-off: 01 July 2019.</recruitment_details>
      <pre_assignment_details>Female participants with a diagnosis of advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based therapy were enrolled to receive niraparib 300 mg in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Niraparib 300 mg</title>
          <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Ongoing at Data Cut-off</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
      <group_list>
        <group group_id="B1">
          <title>Niraparib 300 mg</title>
          <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.4" spread="10.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from First Diagnosis to First Dose</title>
          <description>Duration in years from the date of first diagnosis to the date of start of study drug.</description>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.71" lower_limit="2.5" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Tumor Site</title>
          <description>Participant were categorized based on site of tumor are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Ovarian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Primary Peritoneal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fallopian Tube</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Stage (FIGO) at Time of Initial Diagnosis</title>
          <description>Cancer stage was based on federation of obstetrics and gynecology (FIGO) staging. Stages as I; Only in ovaries (IA: Only in endometrium, IC: Only in one or both ovaries or fallopian tubes); II: Has grown outside ovaries and is growing within pelvis (IIA: Limited to upper two-thirds of vagina, IIC: With positive peritoneal washings or ascites); III: Has spread outside pelvis into abdominal cavity or lymph nodes (IIIA: In lower third of vagina, has not grown into pelvic wall, IIIC: Larger than 2 cm on lining of abdomen and might also be in lymph nodes); IV: Has spread to other body organs.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>IA</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIB</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIIA</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIIC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="155.5" spread="6.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.70" spread="9.701"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Body Mass Index=weight (kg)/[height (m)^2]</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.23" spread="3.936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>The ECOG scale was as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair &gt; 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Only categories with participants are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Prior Lines of Chemotherapy</title>
          <description>Participants were categorized based on number of prior lines of chemotherapy as 3 and 4. Only categories with participants are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Taxane</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants Who Received Taxane</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Bevacizumab</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants Who Received Bevacizumab</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants Who Did Not Received Bevacizumab</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Doxorubicin</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants Who Received Doxorubicin</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants Who Did Not Received Doxorubicin</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Liposomal Doxorubicin</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Who Did Not Received Liposomal Doxorubicin</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Gemcitabine</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants Who Received Gemcitabine</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants Who Did Not Received Gemcitabine</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration between the End Date of the Last Chemotherapy Regimen and the First Dose of Study Treatment</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.1" lower_limit="1" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration between End Date of the Last Platinum-based Therapy and the First Dose of Study Treatment</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.3" lower_limit="1" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Surgery/Procedure for Study Indication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants Who Had Prior Surgery</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Prior Surgery/Procedure for Study Indication</title>
          <units>surgery</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.3" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Radiation Therapy Related to the Study Indication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Had Radiation Therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Had No Radiation Therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Response to Last Platinum-based Therapy</title>
          <description>Response to last platinum-based therapy achieving complete response (CR), partial response (PR), progressive disease (PD) or Stable Disease (SD) per RECIST v.1.1 CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as reference baseline SoD. PD was defined as at least a 20% increase in SoD of target lesions, taking as reference the smallest (nadir) SoD since (and including) baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Response (CR)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response (PR)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stable Disease (SD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time to Progression after the Last Platinum Therapy</title>
          <description>Participants with time to progression were categorized as 6-12 months and more than 12 months. Time to progression is defined as the time from the date of last administration of platinum therapy to the first documentation of disease progression.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>6-12 Month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More Than 12 Month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ovarian Cancer Pathology Histological: Histologic Subtype</title>
          <description>Participants were categorized as serous, endometrioid, mucinous and other for histological subtype of ovarian cancer pathology.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Serous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Endometrioid</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mucinous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ovarian Cancer Pathology Histological: Tumor Grade</title>
          <description>With regard to tumor grading, conventional FIGO/ gynecologic oncology group (GOG)/ world health organisation (WHO) criteria or two-tier system for grading ovarian serous carcinoma is used; participants with grade 3 tumors in FIGO/GOG/WHO criteria (among grade 1 as well differentiated, grade 2 as moderately differentiated, and grade 3 indicates poorly differentiated) or participants with high-grade tumors in two-tier system (among low-grade or high-grade) are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High Grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Germline Breast Cancer (Gene) (BRCA1) Mutant</title>
          <description>Participants were categorized as positive, negative or unknown for mutation of BRCA1 gene. Only categories with participants are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Without Mutant</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Germline BRCA2 Mutant</title>
          <description>Participants were categorized as positive, negative or unknown for mutation of BRCA2 gene. Only categories with participants are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Without Mutant</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Homologous Recombination Deficiency/Deficient (HRD) CDx Test Result</title>
          <description>Participants were categorized as positive, negative and unknown for HRD CDX test result. Only categories with participants are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Genomic Instability Status</title>
          <description>Participants were categorized as positive, negative and unknown for genomic instability status. Only categories with participants are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor BRCA1/BRCA2 Mutation Status</title>
          <description>Participants were categorized as positive, negative and unknown for BRCA1/BRCA2 mutation status.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD.</description>
        <time_frame>Until disease progression, death or data cut-off (Up to approximately 5 months)</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD.</description>
          <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR was defined as the time from the first documented CR or PR per RECIST v. 1.1 to disease recurrence or objective disease progression whichever occurs first. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD.</description>
        <time_frame>Until disease progression, death or data cut-off (Up to approximately 5 months)</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline. Only Responders were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>DOR was defined as the time from the first documented CR or PR per RECIST v. 1.1 to disease recurrence or objective disease progression whichever occurs first. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD.</description>
          <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline. Only Responders were analyzed for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI were not estimable as all participants were censored.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR)</title>
        <description>DCR was defined as the percentage of participants achieving CR, PR or Stable Disease (SD) as assessed by the Investigator per RECIST v. 1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.</description>
        <time_frame>Until disease progression, death or data cut-off (Up to approximately 5 months)</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR)</title>
          <description>DCR was defined as the percentage of participants achieving CR, PR or Stable Disease (SD) as assessed by the Investigator per RECIST v. 1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.</description>
          <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" lower_limit="68.302" upper_limit="98.765"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
        <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3 or Higher TEAEs</title>
        <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
        <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or Higher TEAEs</title>
          <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.</description>
          <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious TEAEs</title>
        <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. An SAE was any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
        <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious TEAEs</title>
          <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. An SAE was any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Leading to Drug Discontinuation</title>
        <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
        <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Leading to Drug Discontinuation</title>
          <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Leading to Dose Interruption</title>
        <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
        <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Leading to Dose Interruption</title>
          <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Leading to Dose Reduction</title>
        <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
        <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Leading to Dose Reduction</title>
          <description>An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participant who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>PFS was defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the RECIST version 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.</description>
        <time_frame>Until disease progression, death or data cut-off (Up to approximately 5 months)</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS was defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the RECIST version 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.</description>
          <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="NA" upper_limit="NA">95% CI was not estimable due to low number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time in months from the study enrollment to death due to any cause.</description>
        <time_frame>Up to data cut-off approximately 6 months</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time in months from the study enrollment to death due to any cause.</description>
          <population>FAS included all participants who received at least 1 dose of study drug and have measurable disease at Baseline.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">OS was not estimable as all participants were alive at the last follow-up.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 30 days after the last dose (Approximately 6 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Niraparib 300 mg</title>
          <description>Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA: 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA: 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tongue discolouration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Eastern Cooperative Oncology Group performance status worsened</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Laryngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Onychomadesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03759600
org study id: Niraparib-2002
secondary id: U1111-1222-4100
secondary id: JapicCTI-184224
nct id: NCT03759600
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate the safety and efficacy of niraparib in participants
      with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary
      peritoneal cancer who have received 3 or 4 previous chemotherapy regimens.
The drug being tested in this study is called niraparib. Niraparib is being tested to treat
      people who have the homologous recombination deficiency (HRD)-positive, advanced, relapsed,
      high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This
      study will look at the efficacy and safety of niraparib in Japanese participants.

      The study will enroll approximately 16 participants. Participants will be enrolled to one
      group and after that will be asked to take niraparib capsules at the same time each day
      throughout the study:

      - Niraparib 300 mg

      This multi-center trial will be conducted in Japan. The overall time to participate in this
      study is approximately 23 months. Participants will make multiple visits to the clinic in the
      treatment period, and the post-treatment period including follow-up assessments after the
      last dose of the study drug.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Until disease progression, death or data cut-off (Up to approximately 5 months)
description: ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD.
measure: Duration of Response (DOR)
time frame: Until disease progression, death or data cut-off (Up to approximately 5 months)
description: DOR was defined as the time from the first documented CR or PR per RECIST v. 1.1 to disease recurrence or objective disease progression whichever occurs first. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD.
measure: Disease Control Rate (DCR)
time frame: Until disease progression, death or data cut-off (Up to approximately 5 months)
description: DCR was defined as the percentage of participants achieving CR, PR or Stable Disease (SD) as assessed by the Investigator per RECIST v. 1.1. CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of diameters (SoD) of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: Up to 30 days after the last dose (Approximately 6 months)
description: An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With Grade 3 or Higher TEAEs
time frame: Up to 30 days after the last dose (Approximately 6 months)
description: An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
measure: Number of Participants With Serious TEAEs
time frame: Up to 30 days after the last dose (Approximately 6 months)
description: An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. An SAE was any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With TEAEs Leading to Drug Discontinuation
time frame: Up to 30 days after the last dose (Approximately 6 months)
description: An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With TEAEs Leading to Dose Interruption
time frame: Up to 30 days after the last dose (Approximately 6 months)
description: An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With TEAEs Leading to Dose Reduction
time frame: Up to 30 days after the last dose (Approximately 6 months)
description: An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
measure: Progression Free Survival (PFS)
time frame: Until disease progression, death or data cut-off (Up to approximately 5 months)
description: PFS was defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the RECIST version 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline.
measure: Overall Survival (OS)
time frame: Up to data cut-off approximately 6 months
description: OS was defined as the time in months from the study enrollment to death due to any cause.
arm group label: Niraparib 300 mg
arm group type: Experimental
description: Niraparib 300 milligrams (mg), capsules, orally, once daily on Days 1 - 28 of each 28-day treatment cycle up to 6 cycles till data cut-off: 01 July 2019.
intervention type: Drug
intervention name: Niraparib
description: Niraparib capsule
arm group label: Niraparib 300 mg
criteria: 
gender: Female
gender based: Yes
gender description: Female participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 previous chemotherapy regimens.
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
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country: Japan
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Fallopian Tube Neoplasms
mesh term: Niraparib
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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