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    Summary
    EudraCT Number:2017-000241-49
    Sponsor's Protocol Code Number:CNIR178X2201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-31
    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 ConcernedSpain - AEMPS
    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
    Estudio fase 2, multicéntrico, abierto, de NIR178 en combinación con
    PDR001, en pacientes con tumores sólidos avanzados seleccionados y linfoma no Hodgkin
    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
    Estudio de eficacia y de seguridad de la combinación de NIR178 y
    PDR001, en pacientes con tumores sólidos seleccionados y linfoma no
    Hodgkin.
    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 Farmacéutica S.A.
    B.1.3.4CountrySpain
    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 Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico (GMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 900353036
    B.5.5Fax number+34 93 2479903
    B.5.6E-maileecc.novartis@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.3.1Product namePBF-509
    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.3.1Product namePBF-509
    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
    Tumores sólidos avanzados y linfoma no Hodgkin
    E.1.1.1Medical condition in easily understood language
    Advanced solid tumors and non-Hodgkin lymphoma
    Tumores sólidos avanzados y linfoma no Hodgkin
    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 100000020935
    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
    - Parte 1: Evaluar la eficacia de la combinación de NIR178 y PDR001
    en pacientes con tumores sólidos avanzados seleccionados y linfoma
    difuso de células B grandes (DLBCL).
    - Parte 2: Evaluar la eficacia de varias posologías de dosis intermitentes de NIR178 en combinación con PDR001 en cáncer de pulmón de células no pequeñas (NSCLC).
    - Parte 3: Evaluar la eficacia de la posología de dosis intermitente de
    NIR178 en NSCLC y en otro tipo de tumor.
    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
    - Evaluar la eficacia de NIR178 + PDR001 en tumores sólidos avanzados seleccionados y linfoma.
    - Evaluar la seguridad y la tolerabilidad de la combinación de NIR178 y
    PDR001.
    - Caracterizar los cambios en el infiltrado inmunológico en los tumores.
    - Caracterizar la farmacocinética (PK) de NIR178, de su metabolito NJI765 y de PDR001 en combinación.
    - Evaluar la inmunogenicidad 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 </= 6 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.
    - Linfomas o tumores sólidos avanzados o metastásicos histológicamente documentados
    . Parte 1: carcinoma de células renales (RCC), cáncer pancreático,
    cáncer urotelial, cáncer de cabeza y cuello, linfoma difuso de
    células B grandes (DLBCL), cáncer de colon con microsatélites
    estables (MSS), cáncer de mama triple negativo (TNBC) o
    melanoma histológicamente confirmado.
    . Parte 2: Diagnóstico histológicamente confirmado de NSCLC
    avanzado/metastásico. Los pacientes con histología mixta, deberán
    presentar una histología predominante.
    . Parte 3: Diagnóstico histológicamente confirmado de NSCLC
    avanzado/metastásico y un tipo de tumor adicional en función de
    los datos que surjan de la parte 1 del estudio.
    - Los pacientes deberán presentar una zona de enfermedad apta para
    biopsia y ser candidatos para biopsia de tumor según las pautas del
    centro que los trate. Los pacientes deberán estar dispuestos a someterse a una nueva biopsia de tumor en la selección y de nuevo
    durante la terapia en este estudio. Se permite el uso de muestra
    reciente bajo las siguientes condiciones (deberán cumplirse ambos
    requisitos):
    . La biopsia fue recogida </= 6 meses antes de la 1ª dosis del
    tratamiento del estudio y estar disponible en el centro.
    . No se le administró inmunoterapia al paciente desde la recogida de la biopsia.
    - Los pacientes deberán haber recibido previamente por lo menos 1 y no más de 3 líneas previas de terapia para su enfermedad.
    - Los pacientes no deberán haber recibido inmunoterapia previa
    (inhibidores del control de la inmunidad (inhibidores checkpoint)
    previos; monoterapia y/o terapia de combinación con anti-CTLA-4,
    anti-PD-1, anti-PD-L1), excepto para los pacientes con NSCLC
    incluidos en la parte 3.
    - Los pacientes deberán presentar enfermedad medible, definida como
    por lo menos una lesión que pueda ser medida de forma precisa en al
    menos una dimensión (deberá registrarse el diámetro más largo para
    las lesiones no nodulares y el eje más corto para las lesions nodulares) como > 20 mm con técnicas convencionales o como > 10
    mm con tomografía computarizada (TC) helicoidal, resonancia
    magnética (RM) o calibradores con examen clinic.

    Pueden aplicar otros criterios de inclusion definidos en el protocolo
    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.
    - Tratamiento previo o en curso con inhibidores del A2aR. Los pacientes tratados previamente con inhibidores de A2aR para indicaciones no oncológicas (por ejemplo, enfermedad de Parkinson) pueden ser considerados para inclusión en una base individualizada.
    - Uso previo o actual de medicación inmunosupresora dentro de los 28 días antes de la primera dosis de PDR001, con la excepción corticosteroides intranasales / inhalados o corticosteroides sistémicos a dosis fisiológicas (no superiores a un equivalente de 10 mg/día de prednisona).
    - Antecedentes de enfermedad pulmonar intersticial o de neumonitis no infecciosa.
    - Antecedentes de otra neoplasia maligna primaria excepto:
    . Neoplasia maligna tratada con fines curativos y sin enfermedad activa conocida >/= 2 años antes de la primera dosis de la medicación del estudio y de bajo riesgo posible de recurrencia.
    . Cáncer cutáneo no melanoma adecuadamente tratado o lentigo maligno sin evidencia de enfermedad.
    . Carcinoma in situ adecuadamente tratado sin evidencia de
    enfermedad.
    - Enfermedad autoinmune documentada previa o activa dentro de los 2 últimos años. Los pacientes con vitíligo, enfermedad de Grave o psoriasis que no precisen tratamiento sistémico (dentro de los 2 años previos) no serán excluidos.
    - Más de 3 líneas de terapia.
    - Participación en otro estudio clínico con un producto de investigación durante los últimos 21 días antes de iniciar el tratamiento.
    Pueden aplicar otros criterios de exclusion definidos en el protocol.
    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.
    En el protocol define momento de evaluación hasta el fin de estudio
    E.5.2Secondary end point(s)
    - DCR (Dose Control Rate), DoR (Duration of Response), PFS (Progression Free Survival), 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
    -TCE (Tasa de Control de la Enfermedad), DR (duración de la respuesta), SLP (supervivencia libre de progresión), Tasa de supervivencia a los 2 años.
    - Frecuencia, Severidad y Seriedad del AE, Anormalidades de laboratorio y otros parámetros de seguridad. Interrupciones de dosis, reducciones e intensidad de dosis.
    - Cambios en los LIT (linfocitos infiltrantes de tumor) respecto a niveles basales.
    - Perfiles de concentración de plasma respecto al tiempo de NIR178, NJI765 y parámetros de farmacocinética. Perfiles de concentraciones de suero respecto al tiempo de PDR001 y parámetros de farmacocinética.
    - Presencia y/o concentración de anticuerpos anti-PDR001.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At protocol define timepoints until End of study.
    En el protocol define momento de evaluación hasta el fin de estudio
    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 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 concerned1
    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.
    El estudio finalizará cuando todos los pacientes hayan completado el periodo de tratamiento y los 150 dias de seguimiento de seguridad y al menos el 80% de los pacientes hayan completado al menos 24 meses de seguimiento de supervivencia desde el inicio de la terapia del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    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 state15
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-11
    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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