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    Summary
    EudraCT Number:2015-000179-29
    Sponsor's Protocol Code Number:CMCS110Z2201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-08
    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 number2015-000179-29
    A.3Full title of the trial
    A randomized phase II study of MCS110 combined with carboplatin and gemcitabine in advanced Triple Negative Breast Cancer (TNBC)
    Estudio de fase II aleatorizado de MCS110 en combinación con carboplatino y gemcitabina en cáncer de mama avanzado triple negativo (CMTN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating if the addition of MCS110 increases the efficacy of chemotherapy in women with disseminated breast cancer that is not dependent on hormones
    Estudio para evaluar si la adición de MCS110 aumenta la eficacia de la quimioterapia en mujeres con cáncer de mama diseminado que no es dependiente de hormonas
    A.4.1Sponsor's protocol code numberCMCS110Z2201
    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 Services 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 Oncología (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 number34900353036
    B.5.5Fax number34932479903
    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 nameMCS110
    D.3.2Product code MCS110
    D.3.4Pharmaceutical form Concentrate 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 INNMCS110
    D.3.9.1CAS number MCS110
    D.3.9.2Current sponsor codeMCS110
    D.3.9.3Other descriptive nameMCS110
    D.3.9.4EV Substance CodeSUB32640
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeMCS110 es una alta afinidad, anticuerpo monoclonal humanizado
    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 Yes
    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 namecarboplatino
    D.3.4Pharmaceutical form 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 INNCARBOPLATINO
    D.3.9.1CAS number CARBOPLATINO
    D.3.9.2Current sponsor codeCARBOPLATINO
    D.3.9.3Other descriptive nameCARBOPLATINO
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 nameGemcitabina
    D.3.4Pharmaceutical form Concentrate 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 INNGEMCITABINA
    D.3.9.1CAS number 95058-81-4
    D.3.9.2Current sponsor codeGEMCITABINA
    D.3.9.3Other descriptive nameGEMCITABINA
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Advanced Triple Negative Breast Cancer
    Cáncer de Mama Avanzado Triple Negativo
    E.1.1.1Medical condition in easily understood language
    Breast Cancer not dependent on hormones
    El cáncer de mama no depende de las hormonas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    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 anti-tumor activity of MCS110 combined with carboplatin/gemcitabine (carbo/gem) compared to carbo/gem alone.
    El objetivo principal es evaluar la actividad antitumoral de MCS110 en combinación con carbo/gem comparado con carbo/gem en monoterapia en pacientes adultas con CMTN.
    E.2.2Secondary objectives of the trial
    1. Characterize the safety and tolerability of MCS110 given in combination with carbo/gem.
    2. Characterize PK of MCS110 when combined with carbo/gem.
    3. Characterize PK of carbo and gem in the presence and absence of MCS110.
    4. Characterize PD effect of MCS110 when combined with carbo/gem
    5. To assess the anti-tumor activity of MCS110 given in combination with carbo/gem as measured by additional efficacy measures.
    - Determinar la seguridad y la tolerabilidad de MCS110 administrado en combinación con carbo/gem
    - Determinar la PK de MCS110 en combinación con carbo/gem.
    - Determinar la PK de carbo/gem en presencia y ausencia de MCS110.
    - Determinar el efecto PD de MCS110 en combinación con carbo/gem.
    - Evaluar la actividad antitumoral de MCS110 administrado en combinación con carbo/gem mediante medidas adicionales de eficacia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult women (? 18 years of age) with advanced TNBC.
    - Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) BC by local laboratory testing, based on last available tumor tissue.
    - ER/PgR negativity to follow local guidelines
    - If IHC HER2 2+, a negative FISH test is required
    A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory (approximately 15% of TAMs or above).
    - Patients must have:
    - At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)
    or
    - Bone lesions: non-measurable lytic or mixed (lytic + sclerotic) in the absence of measurable disease as defined above. Patients with only non-measurable lesions (e.g. pleural effusion, ascites) and no lytic or mixed bone lesions are not eligible.

    Other inclusion criteria may apply
    - Mujeres adultas (? 18 años de edad) con CMTN avanzado.
    - Confirmación histológica o citológica de cáncer de mama con receptor de estrógeno negativo (RE-), receptor de progesterona negativo (RP-) y receptor del factor de crecimiento epidérmico humano 2 negativo (HER2-) mediante pruebas analíticas locales basadas en el último tejido tumoral disponible.
    * Negatividad de RE/RP según las directrices locales.
    * En caso de IHC HER-2 2+, se requiere una prueba FISH negativa.
    - Biopsia del tumor previa al tratamiento que demuestre un alto contenido de TAM según la evaluación del laboratorio central (aproximadamente un 15% de TAM o superior).
    - Las pacientes deben tener:
    Al menos una lesión medible según RECIST 1.1. (Nota: las lesiones medibles incluyen lesiones óseas líticas o mixtas (líticas + blásticas) con un componente de tejido blando identificable que cumpla los criterios de medición).
    E.4Principal exclusion criteria
    - Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed.
    - Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
    - Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
    - Radiotherapy
    - Major surgery
    - Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (?10 mg of prednisone or equivalent) at the time of first dose of study drug.
    - Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
    - Patients with the following laboratory values during screening and on Day 1 pre-dose:
    - Absolute Neutrophil Count (ANC) < 1.0x109/L
    - Hemoglobin < 9 g/dL
    - Platelets < 100x109/L
    - Serum creatinine > 1.5 x ULN
    - Serum total bilirubin > 1.5 x ULN
    - AST/SGOT and ALT/SGPT > 3.0 x ULN

    Other exclusion criteria may apply
    - Tratamiento previo con quimioterapia para CM avanzado. Está permitido tratamiento previo con quimioterapia adyuvante/neoadyuvante.
    - Tratamiento contra la enfermedad maligna subyacente en las 2 semanas anteriores al inicio del tratamiento del estudio:
    * Quimioterapia, terapia biológica (anticuerpos y moléculas pequeñas dirigidas biológicamente).
    * Radioterapia.
    * Cirugía mayor.
    - Pacientes que reciben fármacos inmunosupresores concomitantes o corticosteroides crónicos (prednisona ?10 mg o equivalente) en el momento de la administración de la primera dosis del estudio
    - Enfermedad cardiovascular clínicamente significativa como arritmias sintomáticas o no controladas, insuficiencia cardíaca congestiva o infarto de miocardio durante los 6 meses anteriores a la selección.
    - Antecedentes conocidos del virus de la inmunodeficiencia humana, infección activa por el virus de la hepatitis o cualquier infección sistémica activa no controlada.
    - Pacientes que durante la selección y el día 1 antes de la dosis presenten los valores de laboratorio siguientes:
    * Recuento absoluto de neutrófilos (RAN) < 1,0x109/l.
    * Hemoglobina < 9 g/dl.
    * Plaquetas < 100x109/l.
    * Creatinina sérica > 1,5 x LSN.
    * Bilirrubina sérica total > 1,5 x LSN.
    * AST/SGOT y ALT/SGPT > 3,0 x LSN.
    E.5 End points
    E.5.1Primary end point(s)
    PFS as per RECIST v1.1 (by local investigator assessment)
    SLP según RECIST v1.1 (determinada por la evaluación del investigador local).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor evaluation at sreening and then every six weeeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
    Evaluación del tumor en sreening y luego cada seis semanas hasta el final del ciclo 8. En lo sucesivo, cada 9 semanas (después del ciclo 8).
    E.5.2Secondary end point(s)
    1. Safety: adverse event (AEs), serious adverse events (SAEs) Tolerability: Dose interruptions, reductions and dose intensity
    2. Serum concentration of free MCS110 and derived PK parameters
    3. Plasma concentration of carboplatin, gemcitabine and dFdU (the primary metabolite of gem), and derived PK parameters
    4. Total CSF-I circulating levels, serum CTX-I and circulating monocytes in blood. TAM and TIL content in pre- and post-dose tumor biopsies
    5. Tumor response per RECIST v1.1 (by local investigator assessment):
    Overall Response Rate (ORR), Duration of Response (DOR), Clinical Benefit Rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) ? 6 months) and Overall Survival (OS).
    Seguridad: acontecimientos adversos (AA), acontecimientos adversos graves (AAG). Tolerabilidad: Interrupciones, reducciones e intensidad de la dosis.
    Concentración de MCS110 libre en suero y parámetros PK derivados
    Concentración de carboplatino, gemcitabina y dFdU (el metabolito principal de gem) en plasma y parámetros PK derivados.
    Niveles circulantes totales del CSF-1, CTX-1 en suero y monocitos circulantes en sangre. Contenido de TAM y TIL en biopsias del tumor antes y después de la dosis.
    Respuesta del tumor según RECIST v1.1 (determinada por la evaluación del investigador local): tasa de respuesta global (TRG), duración de la respuesta (DR), tasa de beneficio clínico (respuesta completa (RC) + respuesta parcial (RP) + enfermedad estable (EE) ? 6 meses) y supervivencia global (SG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Continuously
    2. Please refer to protocol section 7
    3. Please refer to protocol section 7
    4. Please refer to protocol section 7
    5. ORR:Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
    DOR: Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
    Clinical benefit rate: Tumor evaluation at screening and then every six weeks until the end of cycle 8. Thereafter every 9 weeks (after cycle 8).
    Overall survival: 4, 6, 9, 12 and 18 months
    1. continuamente
    2. Por favor consulte la sección de protocolo 7
    3. Por favor, consulte la sección de protocolo 7
    4. Por favor, consulte la sección de protocolo 7
    5. TRG: evaluación del tumor en la selección y luego cada seis semanas hasta el final del ciclo 8. sucesivo, cada 9 semanas (después del ciclo 8).
    DOR: evaluación del tumor en la selección y luego cada seis semanas hasta el final del ciclo 8. sucesivo, cada 9 semanas (después del ciclo 8).
    Tasa de beneficio clínico: Tumor de evaluación en la selección y luego cada seis semanas hasta el final del ciclo 8. sucesivo, cada 9 semanas (después del ciclo 8).
    La supervivencia global: 4, 6, 9, 12 y 18 meses
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    carboplatino, gemcitabina
    carboplatin , gemcitabine
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Czech Republic
    France
    Germany
    Hong Kong
    Israel
    Italy
    Korea, Democratic People's Republic of
    Singapore
    Spain
    Taiwan
    Turkey
    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
    End of study will be upon completion of survival follow-up or if the study is terminated early.

    The survival follow-up will end once at least 80% of patients enrolled have died,
    discontinued, withdrawn consent, been lost to follow-up or all the patients have completed the survival follow-up period (18 months after the first dose of treatment), whichever occurs earlier.
    El fin de estudio tendrá lugar una vez completado el seguimiento de la supervivencia o si el estudio finaliza prematuramente.
    El seguimiento de la supervivencia finalizará cuando al menos el 80% de las pacientes incluidas hayan fallecido, se hayan retirado, hayan revocado su consentimiento, sean pérdida de seguimiento o cuando todas las pacientes hayan completado el periodo de seguimiento de la supervivencia (18 meses después de la primera dosis del tratamiento), aquello que ocurra antes.
    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
    E.8.9.2In all countries concerned by the trial months34
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 78
    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
    Ninguno
    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 Decision2015-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-23
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