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    Summary
    EudraCT Number:2014-003773-42
    Sponsor's Protocol Code Number:PM1183-B-005-14
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-003773-42
    A.3Full title of the trial
    A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.
    Estudio clínico multicéntrico de fase II de lurbinectedina (PM01183) en tumores sólidos avanzados seleccionados.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.
    Estudio clínico de lurbinectedina (PM01183) en tumores sólidos avanzados seleccionados.
    A.3.2Name or abbreviated title of the trial where available
    N.A.
    N.A.
    A.4.1Sponsor's protocol code numberPM1183-B-005-14
    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 SponsorPharma Mar S.A. Sociedad Unipersonal
    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 supportPharma Mar, S.A. Sociedad Unipersonal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharma Mar, S.A. Sociedad Unipersonal
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAvd. De Los Reyes nº 1, Pol. Ind. La Mina
    B.5.3.2Town/ cityColmenar Viejo (Madrid)
    B.5.3.3Post code28770
    B.5.3.4CountrySpain
    B.5.4Telephone number3491846 60 87
    B.5.5Fax number3491846 60 03
    B.5.6E-mailclinicaltrials@pharmamar.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 nameLurbinectedina
    D.3.2Product code PM01183
    D.3.4Pharmaceutical form Powder for 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 INNLurbinectedina
    D.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.9.4EV Substance CodeSUB31196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Selected Advanced Solid Tumors.
    Tumores sólidos avanzados seleccionados.
    E.1.1.1Medical condition in easily understood language
    Selected Advanced Solid Tumors.
    Tumores sólidos avanzados seleccionados.
    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 10048683
    E.1.2Term Advanced 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 antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to RECIST v 1.1 in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs) and Ewing´s family of tumors (EFTs).
    Evaluar la actividad antitumoral de lurbinectedina (PM01183) en cuanto a tasa de respuesta global (TRG), de acuerdo con RECIST v. 1.1, en los siguientes tumores sólidos avanzados: carcinoma microcítico pulmonar (CMP), carcinoma de cabeza y cuello (CyC), tumores neuroendocrinos (TNE), carcinoma de vías biliares, carcinoma endometrial, carcinoma de mama metastásico asociado a BRCA 1/2, carcinoma de origen primario desconocido, tumores de células germinales (TCG) y familia de tumores de Ewing (FTE).
    E.2.2Secondary objectives of the trial
    *Characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit (ORR or stable disease (SD) lasting over four months (SD>=4 months)), progression-free survival (PFS) and one-year overall survival (1y-OS) in each cohort of advanced solid tumors.
    *Characterize the plasma pharmacokinetics (PK) of PM01183.
    *Conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis.
    *Evaluate the safety profile of PM01183 in this patient population.
    ?Caracterizar mejor la actividad antitumoral de PM01183 en cuanto a duración de la respuesta (DR), beneficio clínico (TRG o enfermedad estable [EE] durante más de cuatro meses [EE ? 4 meses]), supervivencia libre de progresión (SLP) y supervivencia global a un año (SG-1a) en cada cohorte de tumores sólidos avanzados.
    ?Caracterizar la farmacocinética (FC) plasmática de PM01183.
    ?Realizar un análisis exploratorio farmacogenómico (FGx) y farmacogenético.
    ?Evaluar el perfil de seguridad de PM01183 en esta población de pacientes.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An exploratory pharmacogenomic (PGx) and pharmacogenetic sub-study.
    Un sub-estudio exploratorio farmacogenómico (FGx) y farmacogenético.
    E.3Principal inclusion criteria
    1)Age ? 18 years.
    2)Voluntary signed informed consent (IC) of the patient before any study-specific procedure.
    3)Pathologically proven diagnosis of any of the following malignancies:
    a)Small cell lung cancer (SCLC).
    b)Head and neck carcinoma (H&N). Salivary glands and oropharynx carcinoma are excluded.
    c)Neuroendocrine tumors (NETs), excluding carcinoid tumors.
    d)Biliary tract carcinoma.
    e)Endometrial carcinoma.
    f)BRCA 1/2-associated metastatic breast carcinoma,
    g)Carcinoma of unknown primary site.
    h)Germ cell tumor (GCTs), excluding pure teratocarcinoma.
    i)Ewing?s family of tumors (EFTs).
    4)Prior treatment. Patients must have received:
    a)SCLC: one prior chemotherapy-containing line.
    b)H&N: one or two prior chemotherapy-containing lines.
    c)NETs: one prior chemotherapy-containing line. No more than three prior hormone or biological therapy lines.
    d)Biliary tract carcinoma: one prior chemotherapy-containing line.
    e)Endometrial carcinoma: one prior chemotherapy-containing line.
    f)BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy containing lines.
    g)Carcinoma of unknown primary site: one or two prior chemotherapy-containing lines.
    h)GCTs: no limit of prior therapy (patients with no other clinical therapeutic options).
    i)EFTs: two prior chemotherapy-containing lines.
    5)Measurable disease as defined by RECIST v.1.1, and documented progression before study entry.
    6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) ? 2.
    7)Adequate major organ function:
    a)Hemoglobin ? 9 g/dl, prior red blood cell (RBC) transfusions are allowed if clinically indicated; absolute neutrophil count (ANC) ? 2.0 x 109/l; and platelet count ? 100 x 109/l.
    b)Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ? 3.0 x upper limit of normal (ULN).
    c)Total bilirubin ? 1.5 x ULN, or direct bilirubin
    ? ULN.
    d)Albumin ? 3 g/dl.
    e)Serum creatinine ? 1.5 x ULN.
    f)Creatine phosphokinase (CPK) ? 2.5 x ULN.
    8)Washout periods prior to Day 1 of Cycle 1:
    a)At least three weeks since the last chemotherapy (six weeks if therapy contained nitrosureas or systemic mitomycin C).
    b)At least four weeks since the last monoclonal antibody (MAb)-containing therapy, or radiotherapy (RT) > 30 gray (Gy).
    c)At least two weeks since the last biological/investigational therapy (excluding MAbs) or palliative RT (? 10 fractions or ? 30 Gy total dose).
    9)Grade ? 1 toxicity due to any previous cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v.4). Grade 2 is allowed in case of alopecia and/or peripheral sensory neuropathy.
    10)Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry. Fertile women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation.
    1)Edad ? 18 años.
    2)Consentimiento informado (CI) firmado voluntariamente por el paciente antes de cualquier procedimiento específico del estudio.
    3)Diagnóstico demostrado patológicamente de cualquiera de las neoplasias malignas siguientes:
    a)Carcinoma microcítico pulmonar (CMP)
    b)Carcinoma de cabeza y cuello (CyC). Se excluye el carcinoma de glándulas salivales y de orofaringe.
    c)Tumores neuroendocrinos (TNE), excluidos los tumores carcinoides
    d)Carcinoma de vías biliares
    e)Carcinoma endometrial
    f)Carcinoma de mama metastásico asociado a BRCA 1/2
    g)Carcinoma de origen primario desconocido
    h)Tumor de células germinales (TCG), excluido el teratocarcinoma puro
    i)Familia de tumores de Ewing (FTE)
    4)Tratamiento previo. Los pacientes deben haber recibido:
    a)CMP: una línea de quimioterapia previa.
    b)CyC: una o dos líneas de quimioterapia previas.
    c)TNE: una línea de quimioterapia previa. No más de tres líneas de tratamiento biológico u hormonal previas.
    d)Carcinoma de vías biliares: una línea de quimioterapia previa.
    e)Carcinoma endometrial: una línea de quimioterapia previa.
    f)Carcinoma de mama metastásico asociado a BRCA 1/2: al menos una línea de quimioterapia previa, pero no más de tres.
    g)Carcinoma de origen primario desconocido: una o dos líneas de quimioterapia previas.
    h)TCG: sin límite de tratamiento previo (pacientes sin otras opciones clínicas terapéuticas).
    i)FTE: dos líneas de quimioterapia previas.
    5)Enfermedad medible definida por RECIST v. 1.1 y progresión documentada antes de entrar en el estudio.
    6)Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) ? 2.
    7)Funcionamiento adecuado de los órganos vitales mayores:
    a)Hemoglobina ? 9 g/dl, se permiten transfusiones de eritrocitos previas si está clínicamente indicado; recuento absoluto de neutrófilos (RAN) ? 2,0 x 109/l y recuento plaquetario ? 100 x 109/l
    b)Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) ? 3,0 x límite superior del valor normal (LSN)
    c)Bilirrubina total ? 1,5 x LSN o bilirrubina directa
    ? LSN
    d)Albúmina ? 3 g/dl
    e)Creatinina sérica ? 1,5 x LSN
    f)Creatina fosfocinasa (CPK) ? 2,5 x LSN
    8)Períodos de lavado antes del día 1 del ciclo 1:
    a)Al menos tres semanas desde la última quimioterapia (seis semanas si el tratamiento contenía nitrosoureas o mitomicina C sistémica).
    b)Al menos cuatro semanas desde el último tratamiento que contenía anticuerpos monoclonales (AcM) o radioterapia (RT) > 30 gray (Gy).
    c)Al menos dos semanas desde el último tratamiento biológico/en investigación (AcM excluidos) o RT paliativa (? 10 fracciones o dosis total ? 30 Gy).
    9)Toxicidad de grado ? 1 debido a tratamiento previo para el cáncer según los criterios terminológicos comunes de acontecimientos adversos del Instituto Nacional del Cáncer (NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events v. 4). Se permite el grado 2 en caso de alopecia o neuropatía sensitiva periférica.
    10)En las mujeres en edad de procrear se debe excluir el embarazo con pruebas adecuadas antes de entrar en el estudio. Las mujeres y hombres fértiles deben aceptar utilizar un método anticonceptivo médicamente aceptable durante todo el período de tratamiento y durante como mínimo seis semanas después de la interrupción del tratamiento.
    E.4Principal exclusion criteria
    1)Prior treatment with PM01183 or trabectedin.
    2)Prior or concurrent malignant disease unless in complete remission for more than five years, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma.
    3)Known central nervous system (CNS) involvement. In patients with SCLC, brain computed tomography (CT)-scan results must be provided at baseline.
    4)Relevant diseases or clinical situations which may increase the patient?s risk:
    a)History within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment.
    b)Grade ? 3 dyspnea or daily intermittent oxygen requirement within two weeks prior to the study treatment onset.
    c)Active infection.
    d)Unhealed wounds or presence of any external drainage.
    e)Known chronic active hepatitis or cirrhosis.
    f)Immunocompromised patients, including known infection by human immunodeficiency virus (HIV).
    5)Pregnant or breastfeeding women.
    6)Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
    7)Limitation of the patient?s ability to comply with the treatment or to follow-up the protocol.
    1)Tratamiento previo con PM01183 o trabectedina.
    2)Neoplasia maligna previa o concurrente salvo que haya estado en remisión completa durante más de cinco años, excepto carcinoma de cuello uterino in situ, carcinoma basocelular o espinocelular de la piel y carcinoma de células transicionales de vejiga in situ tratados.
    3)Afectación conocida del sistema nervioso central (SNC). En pacientes con CMP, deben facilitarse los resultados de la tomografía computarizada (TC) cerebral en el momento basal.
    4)Enfermedades o situaciones clínicas relevantes que podrían aumentar el riesgo del paciente:
    a)Antecedentes en el último año o presencia de angina inestable, infarto de miocardio, insuficiencia cardíaca congestiva o valvulopatía cardíaca clínicamente significativa o arritmia sintomática o cualquier arritmia ventricular asintomática que requiera tratamiento actualmente.
    b)Disnea de grado ? 3 o necesidad de oxígeno intermitente diario en las dos semanas anteriores al inicio del tratamiento del estudio.
    c)Infección activa
    d)Heridas no cicatrizadas o presencia de drenaje externo.
    e)Hepatitis activa crónica o cirrosis conocida.
    f)Pacientes inmunodeprimidos, como infección conocida por virus de la inmunodeficiencia humana (VIH).
    5)Mujeres embarazadas o en lactancia
    6)Necesidad inmediata de RT (p. ej., metástasis óseas dolorosas o riesgo de compresión de médula espinal).
    7)Limitación de la capacidad del paciente de cumplir con el tratamiento o el seguimiento del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) in each tumor type. ORR is defined as the percentage of patients with a confirmed response, either complete (CR) or partial (PR), according to the RECIST (v. 1.1).
    Tasa de respuesta global (TRG) en cada tipo de tumor. La TRG se define como el porcentaje de pacientes con una respuesta confirmada, ya sea completa (RC) o parcial (RP), según RECIST (v. 1.1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Along the study.
    A lo largo del estudio.
    E.5.2Secondary end point(s)
    Efficacy:
    ?Duration of Response (DR), defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when PD, recurrence or death is documented.
    ?Clinical Benefit, defined as ORR or stable disease lasting over four months (SD ? 4 months).
    ?Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation.
    ?PFS4/PFS6, defined as the Kaplan-Meier estimates of the probability of being free from progression and death after the first infusion at these time points (4 and 6 months).
    ?OS6/OS12, defined as the Kaplan-Meier estimates of the probability of being alive after the first infusion at these time points (6 and 12 months).
    Plasma Pharmacokinetics (PK) of PM01183
    Non-compartmental (NCA) PK parameters: area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL) and half-life (t1/2). Population PK parameters of the compartment model to be developed (initially based on Volumes and Clearance), and PK/PD correlation parameters, if applicable.
    Pharmacogenetics
    This analysis will be performed in those patients who signed the IC for the pharmacogenetic sub-study. The presence or absence of known polymorphisms from a single sample collected just before the PM01183 treatment start will be assessed to explain the individual variability in the main PK parameters.
    Pharmacogenomics (PGx):
    This exploratory analysis will be performed in those patients treated in any arm who signed the IC for the PGx sub-study. mRNA or protein expression levels of factors involved in DNA repair mechanisms, or related to the mechanism of action of lurbinectedin, will be evaluated from prior available tumor tissue samples obtained at diagnosis or relapse. Their mutational status might be also analyzed. Their correlation with the clinical response and outcome after treatment will be assessed.
    Safety Profile:
    ?Clinical examinations.
    ?Clinical assessment of AEs and serious adverse events (SAEs).
    ?Changes in laboratory parameters (hematological and biochemical, including liver function tests).
    ?Reasons for treatment discontinuations.
    ?Reasons for dose reduction and treatment delays.
    Eficacia:
    ?Duración de la respuesta (DR), definida como el tiempo entre la fecha en que se cumplen los criterios de respuesta (RC o RP, lo que se alcance primero) hasta la primera fecha en que se documenta PE, recidiva o muerte.
    ?Beneficio clínico, definido como TRG o enfermedad estable durante más de cuatro meses (EE ? 4 meses).
    ?Supervivencia libre de progresión (SLP), definida como el período de tiempo desde la fecha de la primera perfusión hasta la fecha de PE, muerte (por cualquier causa) o última evaluación del tumor.
    ?SLP4/SLP6, definida como los cálculos de Kaplan-Meier de la probabilidad de estar libre de progresión y muerte después de la primera perfusión en estos intervalos de tiempo (4 y 6 meses).
    ?SG6/SG12, definida como los cálculos de Kaplan-Meier de la probabilidad de estar vivo después de la primera perfusión en estos intervalos de tiempo (6 y 12 meses).
    Farmacocinética (FC) plasmática de PM01183:
    Parámetros FC no compartimentales (ANC): área bajo la curva (AUC), concentración plasmática máxima (Cmáx), aclaramiento (CL) y semivida (t1/2). Parámetros FC de la población del modelo compartimental a desarrollar (basados inicialmente en volúmenes y aclaramiento) y parámetros de la correlación FC/FD, si procede.
    Farmacogenética:
    Este análisis se realizará en aquellos pacientes que han firmado el CI para el subestudio farmacogenético. Se evaluará la presencia o ausencia de polimorfismos conocidos de una única muestra recogida justo antes de iniciar el tratamiento con PM01183 para explicar la variabilidad individual en los principales parámetros FC.
    Farmacogenómica (FGx):
    Este análisis exploratorio se realizará en los pacientes tratados en cualquier grupo que han firmado el CI para el subestudio FGx. Se evaluarán niveles de expresión de ARNm o proteínas de factores que intervienen en mecanismos de reparación del ADN o relacionados con el mecanismo de acción de lurbinectedina a partir de muestras previas de tejido tumoral obtenidas en el momento del diagnóstico o en la recaída. También se analizará su estado mutacional. Se evaluará su correlación con la respuesta clínica y el resultado después del tratamiento.
    Perfil de seguridad:
    ?Exploraciones físicas.
    ?Evaluación clínica de AA y acontecimientos adversos graves (AAG).
    ?Cambios en los parámetros de laboratorio (hematológicos y bioquímicos, como pruebas de la función hepática.
    ?Motivos para interrumpir el tratamiento.
    ?Motivos para reducir la dosis y retrasar el tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study.
    A lo largo del 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 Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Switzerland
    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
    When all evaluable patients have at least 12 months of follow-up.
    Cuando todos los pacientes evaluables se hayan controlado
    durante al menos 12 meses.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 225
    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 Decision2015-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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