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    Summary
    EudraCT Number:2020-005918-17
    Sponsor's Protocol Code Number:69HCL20_0989
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-02-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-005918-17
    A.3Full title of the trial
    Study of how patient pharmacocinetic covariates influence toxicological events of niraparib as ovarian cancer treatment NIRAPK
    Etude des relations entre propriétés pharmacocinétiques (PK) et
    toxicité hématologique du niraparib dans le cancer de l’ovaire

    NIRAPK
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    relation between pharmacocinetic covariates and toxicological events of niraparib as ovarian cancer treatment

    NIRAPK
    Etude des relations entre propriétés pharmacocinétiques (PK) et
    toxicité hématologique du niraparib dans le cancer de l’ovaire

    NIRAPK
    A.3.2Name or abbreviated title of the trial where available
    NIRAPK
    NIRAPK
    A.4.1Sponsor's protocol code number69HCL20_0989
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLigue Contre le Cancer
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointRegulatory Project Manager
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number0033472406841
    B.5.5Fax number0033472115190
    B.5.6E-maildrci_promo@chu-lyon.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ZEJULA 100mg gélule
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline (Ireland) Limited
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIRAPARIB
    D.3.9.3Other descriptive nameZEJULA 100mg
    D.3.9.4EV Substance CodeSUB177208
    D.3.10 Strength
    D.3.10.1Concentration unit millilitre(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ovarian, tubular or peritoneal high-grade epithelial carcinoma, histologically proven. Recommendation of a maintenance treatment with Niraparib at standard dose (200-300mg/day)
    Cancer épithélial ovarien, tubaire ou péritonéal primitif de haut grade séreux prouvé histologiquement et pour lesquelles il y a une indication de traitement de maintenance par niraparib à dose standard à 300 mg/ jour, ou à dose réduite à 200 mg/ jour
    E.1.1.1Medical condition in easily understood language
    ovarian cancer
    Cancer de l'ovaire
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Identification of clinical/biological/therapeutic or niraparib pharmacokinetic factors that induces hematologic toxicity or nephrotoxicity when it is used according to the Market authorization at the 300mg/day dose or the reduced 200mg/day dose commonly prescribed for high grade serous epithelial ovarian cancer irrespectively of their BRCA-mutated gene or HR status).
    Détermination de l’existence de liens entre covariables cliniques/biologiques/thérapeutiques propres à la patiente et/ou paramètres phamarmacocinétiques du niraparib sur l’apparition de toxicité(s) hématologique(s) et/ou rénales lorsqu’il est utilisé dans le cadre de son AMM à 300mg/jour ou à 200 mg/jour en dose réduite communément prescrite, en traitement d’entretien pour un cancer séreux ovarien de haut grade BRCA muté ou non.
    E.2.2Secondary objectives of the trial
    Identification of clinical and biological/therapeutic/dietary factors that influence Niraparib pharmacokinetic parameters

    Determination of the existence of a causative link between pharmacokinetics parameters and Niraparib efficacy
     Détermination des covariables cliniques/biologiques/thérapeutiques/alimentaires influençant les paramètres pharmacocinétiques du niraparib
     Détermination de l’existence d’un lien entre paramètres pharmacocinétiques et efficacité du niraparib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient Study Information and written informed consent
    • Social Security Affiliation
    • Patient > 18 years old.
    • Ovarian, tubular or peritoneal high-grade epithelial carcinoma, histologically proven.
    - Patients who already received 4 to 6 cures of Platinum-based chemotherapy and with recommendation of a maintenance treatment with Niraparib at standard dose (300mg/day) or at a reduced dose (200mg/day)
    • glomerular filtration rate with standardized serum creatinine values using CKD-EPI formula ≥ 30ml/min/1.73m2 (https://www.kidney.org/professionals/kdoqi/gfr_calculator)
    • Normal liver function with bilirubin < 1.5N
    • 6-8 weeks break between last chemotherapy and Niraparib treatment inititation.
    - Patiente informée et ayant signé un consentement éclairé
    - Patiente affiliée à un régime de sécurité sociale ou bénéficiaire d’un tel régime
    - Femmes âgées de plus de 18 ans
    - Cancer épithélial ovarien, tubaire ou péritonéal primitif de haut grade séreux prouvé histologiquement
    - Patiente ayant déjà reçu 4 à 6 cures de chimiothérapie à base de sel de platine et pour lesquelles il y a une indication de traitement de maintenance par niraparib à dose standard à 300 mg/ jour, ou à dose réduite à 200 mg/ jour au choix de l’investigateur
    - Débit de filtration glomérulaire initiale selon formule CKD-EPI ajustée sur la cystatine C ≥ 30ml/min/1.73m2 (https://www.kidney.org/professionals/kdoqi/gfr_calculator)
    - Fonction hépatique normale avec bilirubinémie < 1.5N
    - Intervalle de 6 à 8 semaines ente la dernière cure de chimiothérapie à base de platine et le début du traitement par Niraparib
    E.4Principal exclusion criteria
    • Miner patient
    • Pregnant or lactating woman
    • Patient not able to understand the aim of the study or under curatorship
    • Low grade carcinoma
    • hypersensitivity to active substance or any of the excipients
    - Patientes mineures
    - Patientes enceintes ou allaitant
    - Patientes inaptes à la compréhension du protocole, ou sous tutelle-curatelle
    - Carcinome de bas grade
    - Hypersensibilité à la substance active du niraparib ou l’un de ces excipients
    E.5 End points
    E.5.1Primary end point(s)
    Identification of clinical/biological/therapeutic and pharmacokinetic factors that induces hematologic toxicity or nephrotoxicity
    Identification des facteurs cliniques/biologiques/thérapeutiques et pharmacocinétiques inducteurs de toxicologie(s) hématologique(s) et/ou rénales
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits n°2, 3, 4 and end of research
    Visite N°2 , 3, 4 et Visite fin d'étude
    E.5.2Secondary end point(s)
    Comparison between clinical and biological/therapeutic/dietary factors and Niraparib pharmacokinetic parameters

    Determination of the existence of a causative link between pharmacokinetics parameters and progresion free Survival at 24 months
    Mise en relation des paramètres pharmacocinétiques moyens observées chez les patientes en fonction des paramètres cliniques/biologiques/thérapeutiques et alimentaires étudiés.
     Mise en relation des paramètres pharmacocinétiques mesurés et de la PFS à 24 mois.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits n°2, 3, 4 and end of research

    In medical chart : After 24 months of treatment
    Visites n°2, 3, 4 et Fin de la recherche

    Dans le dossier médical: Survie sans progression après 24 mois de traitement
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit
    dernier patient dernière visite
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months34
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    aucun
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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