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    Summary
    EudraCT Number:2017-000241-49
    Sponsor's Protocol Code Number:CNIR178X2201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-14
    Trial results View 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 number2017-000241-49
    A.3Full title of the trial
    A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma
    Etude de Phase II, multicentrique, en ouvert, évaluant NIR178 associé à PDR001 chez des patients avec tumeurs solides sélectionnées et lymphomes non Hodgkiniens
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of NIR178 and PDR001 combination in patients with selected solid tumors and non-Hodgkin lymphoma
    A.4.1Sponsor's protocol code numberCNIR178X2201
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address2 et 4 rue Lionel Terray
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@novartis.com
    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 No
    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.3.2Product code NIR178
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot assigned yet
    D.3.9.2Current sponsor codeNIR178
    D.3.9.4EV Substance CodeSUB186624
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.IMP: 2
    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 No
    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.3.2Product code NIR178
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot yet assigned
    D.3.9.2Current sponsor codeNIR178
    D.3.9.4EV Substance CodeSUB186624
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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.IMP: 3
    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 No
    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.3.2Product code PDR001
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet defined
    D.3.9.2Current sponsor codePDR001
    D.3.9.3Other descriptive namePDR001
    D.3.9.4EV Substance CodeSUB171710
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    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) 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 Yes
    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
    Advanced solid tumors and non-Hodgkin lymphoma
    Tumeurs solides sélectionnées et lymphomes non Hodgkiniens
    E.1.1.1Medical condition in easily understood language
    Advanced solid tumors and non-Hodgkin lymphoma
    Tumeurs solides sélectionnées et lymphomes non Hodgkiniens
    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 LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    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
    - Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL)
    - Part 2: To assess the efficacy of several intermittent dosing schedules of NIR178 in combination with PDR001 in NSCLC
    - Part 3: To evaluate efficacy of intermittent dosing schedule of NIR178 in NSCLC and another tumor type
    Partie 1 : Evaluer l’efficacité de NIR178 associé à PDR001 chez des patients atteints de tumeurs solides et de LDGCB
    Partie 2: Evaluer l’efficacité de différents schémas d’administration intermittents de NIR178 associé à PDR001 dans le CBNPC
    Partie 3 : Evaluer l’efficacité des schémas d’administration intermittents de NIR178 dans le CBNPC et un autre type de tumeur
    E.2.2Secondary objectives of the trial
    - To assess efficacy of NIR178+PDR001 in select advanced solid tumors and lymphoma
    - To assess the safety and tolerability of the NIR178 and PDR001 combination
    - To characterize changes in the immune infiltrate in tumors
    - To characterize the pharmacokinetics (PK) of NIR178, its metabolite NJI765 and PDR001 in combination
    - To assess immunogenicity of PDR001
    - Evaluer l’efficacité de NIR178+PDR001 dans une sélection de tumeurs solides et de lymphomes à un stade avancé
    - Evaluer l’innocuité et la tolérance de NIR178 associé à PDR001
    - Caractériser les changements dans les infiltrats immunitaires des tumeurs
    - Caractériser la pharmacocinétique (PK) de NIR178, de son métabolite NJI765 et de PDR001
    - Evaluer l’immunogénicité de PDR001
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically documented advanced or metastatic solid tumors or lymphomas
    . Part 1: histologically confirmed renal cell carcinoma (RCC), pancreatic cancer, urothelial cancer, head and neck cancer, diffuse large B-cell lymphoma (DLBCL), microsatellite stable (MSS) colon cancer, triple negative breast cancer (TNBC) or melanoma
    . Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC. For those with mixed histology, there must be a predominant histology
    . Part 3: histologically confirmed diagnosis of advanced/metastatic NSCLC and one additional tumor type based on emerging data from part 1 of the study.
    - Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy on this study. The collection of recent sample is permitted under the following conditions (both must be met):
    . Biopsy was collected ≤ 3 months before 1st dose of study treatment and available at the site.
    . No immunotherapy was given to the patient since collection of biopsy.
    - Patients must previously have received at least 1 and no more than 3 prior lines of therapy for their disease
    - Patients must not have received prior immunotherapy (previous immune checkpoint inhibitors; single agent and/or combination therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1), except for NSCLC patients enrolled in part 3
    - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral computer tomography (CT) scan, Magnetic Resonance Imaging (MRI), or calipers by clinical exam.

    Other protocol defined inclusion criteria may apply.
    - Tumeurs solides ou lymphomes à un stade avancé ou métastatique (confirmé histologiquement)
    a. Partie 1 : CCR, cancer du pancréas, cancer urothélial, cancer de la tête et du cou, LDGCB, cancer du côlon à microsatellite stable, CSTN, ou mélanome
    b. Partie 2 : CBNPC avancé ou métastatique confirmé histologiquement. Dans le cas de tumeur à histologie mixte, il doit y avoir une histologie prédominante
    c. Partie 3 : CBNPC avancé ou métastatique confirmé histologiquement et un type de tumeur additionnel basé sur les données de la Partie 1
    - Les patients doivent avoir une localisation de la tumeur permettant la réalisation d’une biopsie, et être candidats à une biopsie tumorale selon les directives de l’hôpital. Les patients doivent être prêts à subir une nouvelle biopsie de la tumeur à la sélection, et à un autre moment pendant le traitement. L’utilisation d’un échantillon récent est permise si les deux conditions suivantes sont satisfaites :
    a. Biopsie réalisée moins de 6 mois avant la première dose du traitement à l’étude
    b. Les patients n’ont reçu aucune immunothérapie depuis la biopsie
    - Les patients (excepté ceux atteints de LDGCB) doivent avoir reçu entre 1 et 3 lignes de traitement pour leur maladie
    - Les patients ne peuvent pas avoir été préalablement traités par immunothérapie (inhibiteurs de « checkpoint » immunitaire ; agent unique et/ou association de : anti-CTLA-4, anti-PD-1, anti-PD-L1), sauf pour les patients atteints de CBNPC inclus dans la Partie 3
    - Les patients doivent avoir une maladie mesurable, c’est-à-dire avoir au moins une lésion qui peut être mesurée avec précision dans au moins une dimension (le plus long diamètre pour les lésions non nodales et l’axe court pour les lésions nodales) et mesurant plus de 20 mm par les techniques conventionnelles ou plus de 10 mm par tomodensitométrie spiralée, imagerie par resonance magnétique, ou calipers à l’examen clinique.
    D'autres critères d'inclusion définis par le protocole peuvent s'appliquer.
    E.4Principal exclusion criteria
    - Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR inhibitors for non-oncologic indications (e.g. Parkinson’s disease) may be considered for enrollment on a case by case basis.
    - Current or prior use of immunosuppressive medication within 28 days before the first dose of PDR001, with the exception of intranasal/inhaled corticosteroids or systemic corticosteroids at physiological doses (not exceeding equivalent of 10 mg/day of prednisone)
    - History of interstitial lung disease or non-infectious pneumonitis
    - History of another primary malignancy except for:
    . Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of study drug and of low potential risk for recurrence
    . Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    . Adequately treated carcinoma in situ without evidence of disease
    - Active or prior documented autoimmune disease within the past 2 years. Patients with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
    - More than 3 prior lines of therapy
    - Participation in another clinical study with an investigational product during the last 21 days prior to starting on treatment.

    Other protocol defined exclusion criteria may apply.
    - Traitement actuel ou précédent par des inhibiteurs d’A2aR. Les patients précédemment traités par des inhibiteurs d’A2aR pour des indications non-oncologiques (par ex. maladie de Parkinson) peuvent être inclus au cas par cas.
    - Traitement immunosuppresseur en cours ou antérieur dans les 28 jours précédant la première dose de PDR001, à l’exception des corticostéroïdes par voie intranasale ou inhalé ou des corticostéroïdes systémiques à des doses physiologiques (ne dépassant pas l’équivalent de 10 mg/jour de prednisone).
    - Antécédents d’atteinte interstitielle pulmonaire ou de pneumonite non infectieuse.
    - Antécédents d’autres tumeurs malignes sauf pour :
    a. Tumeur traitée curativement et sans signes connus de l’activité de la maladie depuis les 2 ans précédant la première dose du traitement à l’étude et ayant un faible risque de récidive.
    b. Cancer de la peau autre que le mélanome traité de manière adéquate ou lentigo malin sans signes de la maladie.
    c. Carcinome in situ traité adéquatement sans signes de la maladie.
    - Maladie auto-immune active ou antécédents documentés de maladie auto-immune dans les 2 dernières années.
    Remarque : les patients atteints de vitiligo, de la maladie de Grave, ou de psoriasis ne nécessitant pas un traitement systémique (dans les 2 dernières années) ne seront pas exclus.
    - Plus de 3 lignes de traitement antérieures.
    - Participation à un autre essai clinique avec un médicament expérimental 21 jours précédant la première dose du traitement à l’étude)
    D'autres critères d'exclusion définis par le protocole peuvent s'appliquer.
    E.5 End points
    E.5.1Primary end point(s)
    ORR
    E.5.1.1Timepoint(s) of evaluation of this end point
    At protocol define timepoints until End of study.
    Aux visites définies par le protocole
    E.5.2Secondary end point(s)
    - DCR, DoR, PFS, 2 years Overall Survival rate
    - Frequency, severity and seriousness of AEs, laboratory abnormalities and other safety parameters. Dose interruptions, reductions and dose intensity.
    - Change from baseline in TILs
    - Plasma concentration time profiles of NIR178, NJI765 and PK parameters. Serum concentration time profiles of PDR001 and PK parameters.
    - Presence and/or concentration of anti-PDR001 antibodies
    - Taux de contrôle de la maladie (TCM), durée de la réponse(DDR), survie sans progression (SSP), taux de survie globale (SG) à 2 ans
    - Fréquence, sévérité et gravité des effets indésirables, anomalies des paramètres biologiques et autres paramètres d’innocuité. Doses, interruptions et réductions de dose.
    - Changements par rapport à la baseline des TIL par immunohistochimie (IHC) (tels que CD8)
    - Concentrations plasmatiques en fonction du temps de NIR178, NJI765 et paramètres PK
    - Concentrations sériques en fonction du temps de PDR001 et paramètres PK
    - Présence et/ou concentrations des anticorps anti-PDR001
    E.5.2.1Timepoint(s) of evaluation of this end point
    At protocol define timepoints until End of study.
    Aux visites définies par le protocole
    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) 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 trial6
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Singapore
    Spain
    Switzerland
    Taiwan
    United Kingdom
    United States
    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
    The study will end when all patients have completed the treatment period and 150-day safety follow-up, and at least 80% of patients have completed at least 24 months of survival follow up from start of study therapy.
    L'étude finira lorsque tous les patients auront terminé la période de traitement et un suivi de sécurité de 150 jours, et au moins 80% des patients ont terminé au moins 24 mois de survie après le début de la thérapie d'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 300
    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)
    NA
    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 Decision2017-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-02-14
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