<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/NCT03752216</url>
  </required_header>
  <id_info>
    <org_study_id>GINECO-OV239B</org_study_id>
    <secondary_id>2018-002274-44</secondary_id>
    <nct_id>NCT03752216</nct_id>
  </id_info>
  <brief_title>NIraparib and Quality Of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.</brief_title>
  <acronym>NiQoLe</acronym>
  <official_title>Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib in Maintenance After Platine-based Chemotherapy for Patients With Ovarian Cancer Late Relapse : the French GINECO - NiQoLe Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ARCAGY/ GINECO GROUP</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tesaro, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ARCAGY/ GINECO GROUP</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to&#xD;
      141 patients with ovarian cancer in late relapse treated with niraparib according to the&#xD;
      labelling In France.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of NiQoLe, phase IV study is to evaluate tolerability of Niraparib and the management&#xD;
      by the physicians of the side-effects in real life in France. The study will also generate&#xD;
      complementary data of NOVA trial on longitudinal follow up of closed symptoms and side&#xD;
      effects reported by the patients especially with the NCI PRO (Patient-Reported Outcome)-CTCAE&#xD;
      system. Specific oncogeriatric data will be collected among on a subgroup of elderly&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2019</start_date>
  <completion_date type="Actual">December 13, 2022</completion_date>
  <primary_completion_date type="Actual">August 18, 2021</primary_completion_date>
  <phase>Phase 4</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>
    <masking_description>Open</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction).</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluate treatment toxicities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported fatigue by patient by FACT-F questionnaire (Functional Assessment of Cancer Therapy General - Fatigue)</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>Functional Assessment of Cancer Therapy General Fatigue questionnaire (score range from 0 to 52 - Higher scores represent better quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported symptoms and side effects with the NCI PRO-CTCAE</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>Self-reported symptoms and side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons of the dose modification of Niraparib</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>Reasons of the dose modification of Niraparib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General health-related quality of life by FACT-G questionnaire (Functional Assessment of Cancer Therapy General)</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>Functional Assessment of Cancer Therapy General questionnaire (score range from 0 [worse outcome] to 108 [better outcome])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain related to the treatment by Visual Analogic Scale (VAS)</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>Score range from 0 [worse outcome] to 10 [better outcome])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of interest (HTA, anemia, thrombocytopenia)</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>Side effects of interest (HTA, anemia, thrombocytopenia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Niraparib treatment</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>From the start of Niraparib until progression or unacceptable toxicity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first subsequent line of anti-cancer therapy</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>From the stop of Niraparib to the first subsequent line of anti-cancer therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>Up to 18 months.</time_frame>
    <description>Overall response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initial cognitive functions by FACT-cog (Functional Assessment of Cancer Therapy - Cognitive Function) questionnaire</measure>
    <time_frame>At the inclusion visit</time_frame>
    <description>FACT-cog questionnaire (score range from 0 to 132 - Higher scores represent better functioning)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma level of Niraparib before Niraparib administration</measure>
    <time_frame>Day 8</time_frame>
    <description>residual dosage of Niraparib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma level of Niraparib before Niraparib administration</measure>
    <time_frame>3 months</time_frame>
    <description>residual dosage of Niraparib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])</measure>
    <time_frame>Up to 6 months.</time_frame>
    <description>Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>NIRAPARIB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Niraparib Daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib</intervention_name>
    <description>Two different doses of Niraparib can be administrated:&#xD;
For patient who had at baseline (T0) a body weight ≥ 77 kg and a platelet count ≥ 150 000/µL, Niraparib will be administrated at a dose of 300 mg daily. The planned dose of 300 mg daily will be made up of three 100 mg capsules.&#xD;
For patient who had at baseline (T0) a body weight &lt; 77 kg or a platelet count &lt;150 000/µL, Niraparib will be administrated at a dose of 200 mg daily. The planned dose of 200 mg daily will be made up of two 100 mg capsules.&#xD;
Patient should continue to receive study treatment until disease progression as per RECIST as assessed by the investigator or they do not meet any other discontinuation criteria.</description>
    <arm_group_label>NIRAPARIB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        I-1 Female patients must be ≥ 18 years of age. I-2 Signed informed consent and ability to&#xD;
        comply with treatment and follow-up. I-3 Patients with histologically proved high grade&#xD;
        epithelial ovarian cancer or fallopian tube or primary peritoneal adenocarcioma.&#xD;
&#xD;
        I-4 Platine sensitive and ovarian, fallopian or peritoneal cancer recurrent patients with a&#xD;
        complete response or partial response after a line of platine based chemotherapy.&#xD;
&#xD;
        I-5 Participant must have adequate organ function, defined as follows:&#xD;
&#xD;
          -  Absolute neutrophil count ≥ 1,500/μL&#xD;
&#xD;
          -  Platelets ≥ 100,000/μL&#xD;
&#xD;
          -  Hemoglobin ≥ 9 g/dL&#xD;
&#xD;
          -  Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine&#xD;
             clearance ≥ 30 mL/min using the Cockcroft-Gault equation&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct&#xD;
             bilirubin ≤ 1 x ULN&#xD;
&#xD;
          -  Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver&#xD;
             metastases are present, in which case they must be ≤ 5 x ULN I-6 Patients with an&#xD;
             indication of maintenance by Niraparib after platine based chemotherapy according to&#xD;
             the labelling (see appendix 17).&#xD;
&#xD;
        I-7 As this study will include patients in France, a subject will be eligible in this study&#xD;
        only if either affiliated to, or a beneficiary of, a social category.&#xD;
&#xD;
        I-8 Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
        of ≤ 2.&#xD;
&#xD;
        I-9 Participant receiving corticosteroids may continue as long as their dose is stable for&#xD;
        least 4 weeks prior to initiating protocol therapy.&#xD;
&#xD;
        I-10 Participant must agree to not donate blood during the study or for 90 days after the&#xD;
        last dose of Niraparib.&#xD;
&#xD;
        I-11 Female participant has a negative urine or serum pregnancy test within 7 days prior to&#xD;
        taking study treatment if of childbearing potential and agrees to abstain from activities&#xD;
        that could result in pregnancy from screening through 1 month after the last dose of study&#xD;
        treatment, or is of nonchildbearing potential.&#xD;
&#xD;
        I-12 Participant must agree to not breastfeed during the study or for 1 month after the&#xD;
        last dose of Niraparib.&#xD;
&#xD;
        I-13 Participant must have normal blood pressure or adequately treated and controlled&#xD;
        hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        E-1 Known hypersensitivity or allergy to active principle or to any components or&#xD;
        excipients of the Niraparib formulation.&#xD;
&#xD;
        E-2 Participant must not be simultaneously enrolled in any interventional clinical trial.&#xD;
&#xD;
        E-3 Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol&#xD;
        therapy and participant must have recovered from any surgical effects.&#xD;
&#xD;
        E-4 Participant must not have received investigational therapy ≤ 4 weeks, or within a time&#xD;
        interval less than at least 5 half-lives of the investigational agent, whichever is&#xD;
        shorter, prior initiating protocol therapy.&#xD;
&#xD;
        E-5 Participant last treatment with platinum-based chemotherapy was ≥12 weeks from&#xD;
        initiation of protocol therapy E-6 Participant has had radiation therapy encompassing &gt;20%&#xD;
        of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of&#xD;
        protocol therapy.&#xD;
&#xD;
        E-7 Participant must not have received a transfusion (platelets or red blood cells) ≤ 4&#xD;
        weeks NiQoLe - Study protocol - v3.0 on 08/10/2020 Page 10 on 109 N° EudraCT:&#xD;
        2018-002274-44 prior to initiating protocol therapy. E-8 Participant must not have received&#xD;
        colony stimulating factors (e.g., granulocyte colonystimulating factor, granulocyte&#xD;
        macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior&#xD;
        initiating protocol therapy. E-9 Participant has had any known Grade 3 or 4 anemia,&#xD;
        neutropenia or thrombocytopenia due to prior chemotherapy that persisted &gt; 4 weeks and was&#xD;
        related to the most recent treatment. E-10 Participant must not have any known history of&#xD;
        myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). E-11 Participant must not&#xD;
        have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active,&#xD;
        uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular&#xD;
        arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure&#xD;
        disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric&#xD;
        disorder that prohibits obtaining informed consent. E-12 Participant must not be deprived&#xD;
        of liberty, under guardianship or under trusteeship.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florence JOLY, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre François Baclesse 3, avenue du Général Harris 14076 CAEN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sainte-Catherine Institut du Cancer Avignon-Provence</name>
      <address>
        <city>Avignon</city>
        <zip>84918</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de la Côte Basque</name>
      <address>
        <city>Bayonne</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Tivoli</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Fleyriat</name>
      <address>
        <city>Bourg-en-bresse</city>
        <zip>01012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medipole de Savoie</name>
      <address>
        <city>Challes-les-Eaux</city>
        <zip>73190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SASU Centre d'Oncologie et Radiothérapie 37</name>
      <address>
        <city>Chambray-lès-Tours</city>
        <zip>37170</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges François Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard</name>
      <address>
        <city>Grenoble</city>
        <zip>38028</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Les Hôpitaux de Chartres - Hôpital Louis Pasteur</name>
      <address>
        <city>Le Coudray</city>
        <zip>28630</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé Jean Mermoz</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICM Val d'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ORACLE - Centre d'Oncologie de Gentilly</name>
      <address>
        <city>Nancy</city>
        <zip>54100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre ONCOGARD - Institut de Cancérologie du Gard</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régional d'Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Diaconesses-Croix Saint Simon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre CARIO - HPCA</name>
      <address>
        <city>Plérin</city>
        <zip>22190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut du Cancer Courlancy</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Saint-Malo</name>
      <address>
        <city>Saint-Malo</city>
        <zip>35400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste de l'Estuaire</name>
      <address>
        <city>Saint-nazaire</city>
        <zip>44600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint-Etienne - Pôle de Cancérologie</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42271</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg - Institut de Cancérologie Strasbourg Europe</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Anti-PARP (poly-ADP ribose polymerase)</keyword>
  <keyword>Late Relapse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niraparib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03752216
org study id: GINECO-OV239B
secondary id: 2018-002274-44
nct id: NCT03752216
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to
      141 patients with ovarian cancer in late relapse treated with niraparib according to the
      labelling In France.
The aim of NiQoLe, phase IV study is to evaluate tolerability of Niraparib and the management
      by the physicians of the side-effects in real life in France. The study will also generate
      complementary data of NOVA trial on longitudinal follow up of closed symptoms and side
      effects reported by the patients especially with the NCI PRO (Patient-Reported Outcome)-CTCAE
      system. Specific oncogeriatric data will be collected among on a subgroup of elderly
      patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open
measure: Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction).
time frame: 3 months
description: Evaluate treatment toxicities
measure: Self-reported fatigue by patient by FACT-F questionnaire (Functional Assessment of Cancer Therapy General - Fatigue)
time frame: Up to 18 months.
description: Functional Assessment of Cancer Therapy General Fatigue questionnaire (score range from 0 to 52 - Higher scores represent better quality of life)
measure: Self-reported symptoms and side effects with the NCI PRO-CTCAE
time frame: Up to 18 months.
description: Self-reported symptoms and side effects
measure: Reasons of the dose modification of Niraparib
time frame: Up to 18 months.
description: Reasons of the dose modification of Niraparib
measure: General health-related quality of life by FACT-G questionnaire (Functional Assessment of Cancer Therapy General)
time frame: Up to 18 months.
description: Functional Assessment of Cancer Therapy General questionnaire (score range from 0 [worse outcome] to 108 [better outcome])
measure: Pain related to the treatment by Visual Analogic Scale (VAS)
time frame: Up to 18 months.
description: Score range from 0 [worse outcome] to 10 [better outcome])
measure: Side effects of interest (HTA, anemia, thrombocytopenia)
time frame: Up to 18 months.
description: Side effects of interest (HTA, anemia, thrombocytopenia)
measure: Duration of Niraparib treatment
time frame: Up to 18 months.
description: From the start of Niraparib until progression or unacceptable toxicity.
measure: Time to first subsequent line of anti-cancer therapy
time frame: Up to 18 months.
description: From the stop of Niraparib to the first subsequent line of anti-cancer therapy.
measure: Overall response rate
time frame: Up to 18 months.
description: Overall response rate
measure: Initial cognitive functions by FACT-cog (Functional Assessment of Cancer Therapy - Cognitive Function) questionnaire
time frame: At the inclusion visit
description: FACT-cog questionnaire (score range from 0 to 132 - Higher scores represent better functioning)
measure: Plasma level of Niraparib before Niraparib administration
time frame: Day 8
description: residual dosage of Niraparib
measure: Plasma level of Niraparib before Niraparib administration
time frame: 3 months
description: residual dosage of Niraparib
measure: Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])
time frame: Up to 6 months.
description: Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])
arm group label: NIRAPARIB
arm group type: Experimental
description: Oral Niraparib Daily
intervention type: Drug
intervention name: Niraparib
description: Two different doses of Niraparib can be administrated:
For patient who had at baseline (T0) a body weight ≥ 77 kg and a platelet count ≥ 150 000/µL, Niraparib will be administrated at a dose of 300 mg daily. The planned dose of 300 mg daily will be made up of three 100 mg capsules.
For patient who had at baseline (T0) a body weight < 77 kg or a platelet count <150 000/µL, Niraparib will be administrated at a dose of 200 mg daily. The planned dose of 200 mg daily will be made up of two 100 mg capsules.
Patient should continue to receive study treatment until disease progression as per RECIST as assessed by the investigator or they do not meet any other discontinuation criteria.
arm group label: NIRAPARIB
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Florence JOLY, MD, PhD
role: Principal Investigator
affiliation: Centre François Baclesse 3, avenue du Général Harris 14076 CAEN
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country: France
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Niraparib