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    Summary
    EudraCT Number:2021-003042-20
    Sponsor's Protocol Code Number:ET21-169
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-13
    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 number2021-003042-20
    A.3Full title of the trial
    PARPi-PANC - A multicentric, single arm, phase II trial assessing the efficacy of niraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer
    PARPi-PANC - Etude multicentrique, monobras, de phase II évaluant l’efficacité du niraparib en première ligne de traitement chez les patients présentant un cancer du pancréas métastatique avec un déficit de la recombinaison homologue
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study assessing the efficacy of niraparib as first line therapy with pancreatic cancer patient's
    Etude évaluant l'efficacité du niraparib en première ligne de traitement chez les patients atteints d'un cancer du pancréas
    A.3.2Name or abbreviated title of the trial where available
    PARPi-PANC
    PARPi-PANC
    A.4.1Sponsor's protocol code numberET21-169
    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 SponsorCentre Léon Bérard
    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 supportGlaxoSmithKline (GSK) Group Company
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointDRCI - Phases précoces
    B.5.3 Address:
    B.5.3.1Street Address28 rue Laennec
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69373 Cedex 08
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)4 26 55 68 24
    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
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline (Ireland) Limited
    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.3.11 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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    Patients with metastatic homologous repair-deficient pancreatic cancer
    Patients présentant un cancer du pancréas métastatique avec un déficit de la recombinaison homologue
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer
    Cancer du pancréas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of niraparib in patients with HR-deficient pancreatic cancer.
    Evaluer l’efficacité du niraparib chez les patients présentant un cancer du pancréas avec un déficit de la recombinaison homologue (HR)
    E.2.2Secondary objectives of the trial
    - To further document the clinical activity of niraparib in patients with HR-deficient pancreatic cancer

    - To assess the safety and tolerability of niraparib in pancreatic cancer patients
    - Documenter l’activité clinique du niraparib chez les patients avec un cancer du pancréas avec un déficit de la HR

    - Evaluer le profil sécurité et de tolérance du niraparib chez les patients atteints d’un cancer du pancréas
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The objectives of the translational part the following:
    1) To assess the correlation between molecular alterations and response separating BRCA1/2 mutations from other HR alterations.
    2) to assess mechanism of resistance using optional tumor biopsy in case of PD under niraparib treatment using the same HRD panel.
    3) To assess the predictive value of existing mutated variants (KRAS for example), as well as the apparition of new variants in predicting resistance to niraparib using ctDNA monitored both qualitatively and quantitatively throughout the study (Screening, C3D1, C5D1, C7D1, EOT/PD).
    Les objectifs de la partie translationnelle sont les suivants :
    1) la corrélation entre les altérations moléculaires et la réponse au traitement en fonction de la mutation de la tumeur (BRCA1/2 versus autres mutations HR) ;
    2) le mécanisme de résistance en cas de progression sous niraparib grâce au même panel HRD (biopsie tumorale) ;
    3) la valeur prédictive de la présence de variants mutés déjà existants (ex : KRAS) ou de la survenue de nouveaux variants afin de prédire la résistance au niraparib (ADN circulant tumoral dosé qualitativement et quantitativement au cours de l’étude (screening, C3J1, C5J1, C7J1, EOT/PD)).
    E.3Principal inclusion criteria
    I1. Male or female patient ≥18 years of age at time of informed consent form signature.
    I2. Histologically proven advanced/metastatic PDAC not curable by surgery and/or definitive radiotherapy and not previously exposed to chemotherapy in advanced/metastatic setting. See Note in the full protocol
    I3. Documented deleterious alteration resulting in the bi-allelic inactivation in at least one of the following genes BARD1, BRCA1, BRCA2, BRIP1, FANCA, FANCD2, FANCL, MRE11, NBN, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L. See Notes in the full protocol
    I4. Measurable disease at baseline according to RECIST V1.1 (See Section Appendix) See note in the full protocol
    I5. For patient with an unknown HR status, a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality/quantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2. For patients with known HR defect in the tumor, an archival tumor sample will be collected if available.
    … See the protocol
    I1. Homme ou femme âgé(e) ≥18 ans à la date de signature du consentement.
    I2. Diagnostic confirmé par un examen histologique d’adénocarcinome du pancréas (PDAC) en phase avancée/métastatique incurable par une chirurgie et/ou une radiothérapie et non précédemment traité par chimiothérapie en phase avancée/métastatique. Voir notes dans le protocole.
    I3. Altérations délétères documentées avec une inactivation bi-allélique d’au moins un des gènes suivants : BARD1, BRCA1, BRCA2, BRIP1, FANCA, FANCD2, FANCL, MRE11, NBN, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L. voir Notes dans le protocole.
    I4. Maladie mesurable selon les critères RECIST V1.1.
    I5. Pour les patients avec un statut HR inconnu avant le screening, un échantillon tumoral fixé en formol et inclus en paraffine (FFIP) (tumeur primitive ou métastase) (résection chirurgicale ou biopsie) associé à un compte-rendu anatomopathologique devra être disponible afin de réaliser ce screening. Cet échantillon devra répondre aux critères de contrôle qualitatif et quantitatif : ≥ 30% de cellules tumorales et une surface tumorale ≥ 5mm2. Pour les patients avec une tumeur avec statut HR connu, un échantillon tumoral archivé sera collecté si disponible.
    ...Voir le protocole
    E.4Principal exclusion criteria
    E1. Patients not respecting the requirement for prior and concomitant treatment...
    E2. Inability to swallow capsules (bowel obstruction) or hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
    E3. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. See notes in the full protocol.
    E4. Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.
    E5. Any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
    ...See the protocol
    E1. Patients ne respectant pas les recommandations relatives aux traitements antérieurs et concomitants.
    E.2 Patient incapable d’avaler des comprimés (obstruction intestinale) ou présentant une intolérance au galactose, un déficit en lactase de Lapp ou un syndrome de malabsorption du glucose et du galactose
    E3. Patients présentant des métastases du système nerveux central (SNC) symptomatiques, non traitées ou actives. Voir Notes dans le protocole.
    E4. Patient présentant un autre type de cancer, sauf s’il est avéré que ce cancer n’est pas susceptible d’avoir un impact sur l’évaluation des critères de jugements de l’étude (carcinome cutané basocellulaire ou épidermoïde de la peau, carcinome in situ du col de l'utérus, cancer de la prostate localisé) ou tout autre cancer sans évidence de récidive depuis ≥ 2 ans.
    E5. Tout antécédent connu de syndrome myélodysplasique (SMD) ou de leucémie myéloïde aigue (LMA).
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate
    Taux de réponse objective
    E.5.1.1Timepoint(s) of evaluation of this end point
    After Week 16 (ORR-16W)
    Après 16 semaines de traitement (ORR-16W)
    E.5.2Secondary end point(s)
    Disease control rate (DCR)
    Best overall response Rate according to RECIST V1.1
    Duration of response (DoR),
    Progression Free survival (PFS)
    Overall survival (OS)
    Taux de contrôle de la maladie
    Taux de meilleure réponse globale (BORR)
    Durée de la réponse (DoR)
    Survie sans progression (PFS)
    Survie globale (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 16 weeks of treatment (DRC-16W)
    Après 16 semaines de traitement (DCR-16W)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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
    LPLV
    La dernière visite du dernier patient
    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 months48
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-04-13. Yes
    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 state28
    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)
    A la discrétion du médecin
    At the physician discretion

    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 Decision2022-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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