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    Summary
    EudraCT Number:2014-001549-26
    Sponsor's Protocol Code Number:TRASTS
    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:2014-10-03
    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 number2014-001549-26
    A.3Full title of the trial
    Phase I-II prospective trial, multicenter, open label, exploring the combination of Trabectedin plus Radiotherapy in Soft Tissue Sarcoma patients.
    Ensayo clinico Fase I-II, abierto, prospectivo y muticéntrico, que explora la combinación de Trabectedina y Radioterapia en pacientes con Sarcoma de tejidos Blandos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial that evaluates the combination treatment of Trabectedin and Radiotherapy in Soft Tissue Sarcoma patients.
    Ensayo clínico que evalúa la combinación de Trabectedina y Radioterapia para el tratamiento de pacientes con sarcoma de tejidos blandas.
    A.4.1Sponsor's protocol code numberTRASTS
    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 SponsorGEIS
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharmaMar
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGEIS
    B.5.2Functional name of contact pointMelissa Fernández Pinto
    B.5.3 Address:
    B.5.3.1Street AddressC/ Diego de Leon 47, Ed Melior 26
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number0034912866807
    B.5.5Fax number0034918388588
    B.5.6E-mailmelissa.crc@grupogeis.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name YONDELIS 1 mg powder for concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/01/039
    D.3 Description of the IMP
    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 INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Soft Tissue Sarcoma
    Sarcoma de tejidos blandos
    E.1.1.1Medical condition in easily understood language
    Soft Tissue Sarcoma
    Sarcoma de tejidos blandos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cohort A (Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma), and Cohort B (Patients with locally advanced resectable Myxoid Liposarcoma) primary objective is response to treatment of the combination of trabectedin plus radiation therapy.
    El objetivo principal de los pacientes de Cohorte A (pacientes con sarcomas de partes blandas con metástasis limitadas a pulmones no operables, o no resecables o no recomendable una metastasectomía ) y pacientes de la Cohorte B (Paciente con Liposarcoma mixoide resecable y localmente avanzado) es la respuesta al tratamiento de combinación de trabectedina y radioterapia
    E.2.2Secondary objectives of the trial
    For Cohort A:
    - Toxicity profile
    - Efficacy response
    -CHOI criteria response
    - Quality of Life
    For Cohort B:
    - Toxicity profile
    -Activity
    -Efficacy
    -CHOI criteria response
    -Quality of life measured
    Cohorte A:
    - Perfil de toxicidad
    - Eficacia de respuesta,
    -Criterios de respuesta CHOI
    -Calidad de vida
    Cohorte B:
    - Perfil de toxicidad
    -Actividad
    - Eficacia
    - Criterios de respuesta CHOI
    - Calidad de vida
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Traslational sub-study to determine the action mechanism of trabectedin in patients with soft tissue sarcoma and evaluate the efficacy of combined treatment of trabectedin and radiotherapy
    Date and version:
    Objectives of sub-study are to determine:
    Protein expression of FASr, CUL4A, p53, NFAT, p21, HMGA1, E2F1
    RNA expression of these genes
    Pharmacodinamics in cohort B
    Blood detection of HMGA1 and E2F1 (pre and post treatment)
    Titulo: Sub estudio traslacional para determnar el mecanismo de acción de trabectedina en pacientes con sarcoma de partes blandas y valorar la eficacia del tratamiento combinado de trabectedina y radioterapia.
    Date and version:
    Los objetivos del subestudio son determinar:
    Expresion de proteina en FASr, CUL4A, p53, NFAT, p21, HMGA1, E2F1
    Expresion de ARN de estos genes
    Farmacodinámica en la cohorte B
    Detección en sangre de HMGA1 y E2F1 (pre y post tratamiento
    E.3Principal inclusion criteria
    Inclusion Criteria Cohort A
    - Aged between 18 and 70.
    - Patients must have a diagnostic of Soft Tissue Sarcoma with metastasis limited to lung, and not suitable for metatasectomy or surgery resection or not oncologically recommended metastasectomy
    - Patients must have documentation of disease progression within 6 months prior to study entry.
    - The patient must have been considered eligible for systemic chemotherapy. A maximum of two previous lines for advanced/metastatic disease are allowed as long as trabectedin has not been included.
    - The following histological subtypes can be included:
    + Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma)
    + Leiomyosarcoma
    + Angiosarcoma/ epithelial hemangioendothelioma
    + Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid/round cells, pleomorphic)
    + Synovial sarcoma
    + Fibrosarcoma and its variants (epithelial fibrosarcoma/low grade fibromyxoid sarcoma)
    + Hemangiopericytoma/solitary fibroid tumor
    + Neurogenic sarcoma (Malignant peripheral nerve sheath tumor, MPNST)
    + Myxofibrosarcoma
    + Epithelioid Sarcoma
    + Unclassified sarcoma (spindle cell/epithelioid/pleomorphic/myxoid)
    + Measurable disease, according to RECIST V 1.1 criteria
    + Adequate respiratory functions: FEV1 >1L
    - Adequate bone marrow function (hemoglobin > 10 g/dl, leukocytes ? 3.000/mm3, neutrophils ? 1.500/mm3, platelets ? 100.000/mm3). Patients with plasma creatinine ? 1,6 mg/dl, transaminases ? 2.5 times the UNL, total bilirubin ? UNL, CPK ? 2.5 times UNL, alkaline phosphatase ? 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5? nucleotidase and/or GGT must be ? UNL.
    - Normal cardiac function with a LVEF ? 50% by echocardiogram or MUGA.
    - Disease distribution in lungs allows meeting with normal tissue constraints of radiation therapy. Radiation therapist must confirm this point.
    - Patient must have a Central Venous Catheter for treatment
    Cohort B
    - Aged between 18 and 70.
    - Pathological diagnosis of Myxoid Liposarcoma, deep located and more than 5 cm or superficial more than 10 cm.
    - Tumor must be resectable and without evidence of regional or distal spread after adequate staging procedure. Tumor must be located in limbs or superficial trunk wall.
    - Disease distribution allows meeting with normal tissue constraints of radiation therapy. Radiation therapist must confirm this point.
    - Measurable disease, according to RECIST V 1.1 criteria
    - Adequate bone marrow function (hemoglobin > 10 g/dL, leukocytes ? 3.000/mm3, neutrophils ? 1.500/mm3, platelets ? 100.000/mm3). Patients with plasma creatinine ? 1,6 mg/dL, transaminases ? 2.5 times the UNL, total bilirubin ? UNL, CPK ? 2.5 times UNL, alkaline phosphatase ? 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5? nucleotidase and/or GGT must be ? UNL.
    - Normal cardiac function with a LVEF ? 50% by echocardiogram or MUGA.

    - Patient may have had one previous chemotherapy line.
    - Patient must have a Central Venous Catheter for treatment.
    Cohorte A:
    - Edad entre 18 y 70 años
    - Pacientes con diagnóstico de sarcomas de partes blandas con metástasis limitadas a pulmones no operables, o no resecables o no recomendable una metastasectomía
    -Pacientes deben haber tenido una progresión a la enfermedad en los 6 meses previos a la inclusión en el estudio.
    - Pacientes deber ser elegibles para quimioterapia sistémica. Se permite un máximo de dos líneas previas para la enfermedad avanzada /metastásica siempre que no se haya incluido trabectedina.
    - Los siguientes subtipos histológicos pueden ser incluidos:
    +Sarcoma pleomórfico indiferenciado (previamente histiocitoma maligno fibroso)
    +Leiomiosarcoma
    +Angiosarcoma/hemangioendotelioma epitelial
    +Liposarcoma y sus variantes (bien diferenciado, desdiferenciado, mixoide/de celulas redondas, pleomórfico)
    +Sarcoma sinovial
    +Fibrosarcoma y sus variantes (Fibrosarcoma epitelial/Sarcoma fibromixoide de bajo grado)
    +Hemangiopericitoma/Tumor fibroide solitario
    +Sarcoma neurogénico (tumor maligno de vaina nerviosa periférica, MPNST)
    +Mixofibrosarcoma
    +Sarcoma epiteloide
    +Sarcoma inclasificado (de celulas fusiformes/epiteloide/pleomórfico/mixoide)
    -Enfermedad medible, según criterios RECIST v 1.1
    -Funciones respiratorias adecuadas FEV1>1L
    - Parametros hematológicos y bioquímicos adecuados: (hemoglobina > 10 g/dl, leukocitos ? 3.000/mm3, neutrofilos ? 1.500/mm3, plaquetass ? 100.000/mm3).
    Pacientes con creatinina plasmática ? 1,6 mg/dl, transaminasas ? 2.5 veces el límite superior, bilirubina total ? limite superior normal, CPK ? 2.5 veces el limite superior normal, fosfatasa alcalina ? 2.5 el limite superior es aceptable. Si el aumento de la fosfatasa alclaina es > 2.5 veces el límite superior normal , entonces la fracción hepática de la fosfatasa alcalina y/o nucleotidasa 5 y/o GGT deben ser ? que el limite superior de normalidad.
    - Función cardiaca normal con FEVI ? 50%, por ecocardiograma o MUGA.
    - Distribución de la enfermedad en pulmones permite adaptarse a las restricciones normales del tejido sano en radioterapia. El radioterapeuta debe confirmar este punto.
    -Pacientes deben tener un acceso venoso central.
    Cohorte B
    -Edad de 18 a 70 años.
    -Diagnóstico de Liposarcoma Mixoide, localizado profundamente y a más de 5cm, o superficial a más de 10cm.
    -El tumor debe ser rescable y sin evidencia de extensión regional o distal despues de los procedimientos de estadiaje. El tumor debe estar en las extremidades superiores e inferiores o superficialmente en la pared torácica.
    -La distribucion de la enfermedad permite encontrarse con limitaciones en el tejido normal, el radioterapeuta debe confirmar este criterio.
    -Enfermedad medible, siguiendo la criteria RECIST 1.1
    -Parametros hematológicos y bioquímicos adecuados: (hemoglobina > 10 g/dl, leukocitos ? 3.000/mm3, neutrofilos ? 1.500/mm3, plaquetass ? 100.000/mm3).
    Pacientes con creatinina plasmática ? 1,6 mg/dl, transaminasas ? 2.5 veces el límite superior, bilirubina total ? limite superior normal, CPK ? 2.5 veces el limite superior normal, fosfatasa alcalina ? 2.5 el limite superior es aceptable. Si el aumento de la fosfatasa alclaina es > 2.5 veces el límite superior normal , entonces la fracción hepática de la fosfatasa alcalina y/o nucleotidasa 5 y/o GGT deben ser ? que el limite superior de normalidad.
    -Función cardiaca normal con una FEVI de ? 50% por ecocardiograma o MUGA.
    -Paciente debe haber recibido una línea previa de tratamiento.
    -Pacientes deben tener un acceso venoso central.
    E.4Principal exclusion criteria
    Cohort A
    - Previous treatment with trabectedin or radiotherapy involving any lung field.
    - Performance status ? 2 (ECOG).
    - Metastases out of those located in lungs.
    - Plasma bilirubin > UNL.
    - Creatinine > 1.6 mg/dL.
    - History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
    - Severe COPD or other severe pulmonary diseases.
    - Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
    - Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
    - Uncontrolled bacterial, mycotic or viral infections.
    - Known positive test for infection by human immunodeficiency virus (HIV).
    - Women who are pregnant or breast-feeding.




    Cohort B
    1. More than one previous chemotherapy treatment for local disease including trabectedin.
    2. Radiotherapy involving the tumoral bed.
    3. Performance status ? 2 (ECOG).
    4. Presence of metastases or lymph node involvement by the tumor.
    5. Location other than limb or superficial trunk wall.
    6. Plasma bilirubin > UNL.
    7. Creatinine > 1.6 mg/dL.
    8. History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
    9. Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
    10. Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
    11. Uncontrolled bacterial, mycotic or viral infections.
    12. Known positive test for infection by human immunodeficiency virus (HIV).
    13. Women who are pregnant or breast-feeding.
    14. Psychological, familial, social or geographic circumstances that limit the patient?s ability to comply with the protocol or informed consent.
    15. Patients participating in another clinical trial or receiving any other investigational product.
    16. Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
    Cohorte A:
    - Tratamiento previo con trabectedina, o radioterapia en cualquier area de pulmón.
    - Estado Funcional (ECOG) ? 2
    - Metastasis localizadas fuera del pulmón.
    - Bilirrubina plasmática ? limite superior normalidad (LSN)
    -Creatinina ? 1.6 mg/dl
    - Otra enfermedad neoplásica a excepción de carcinoma basocelular o cancer de cervix in situ tratado adecuadamente.
    - EPOC severo u otras enfermedades pulmonares graves.
    - Enfermedad cardiovascular significativa (por ejemplo, disnea ? 2 NYHA)
    - Enfermedad sistémica significativa grado 3 o mayor medida por CTCAE v4.03, que limite la disponibilidad del paciente, o a juicio del investigador que pueda contribuir de manera significativa a la toxicidad del tratamiento.
    - Infecciones bacterianas, micóticas o virales no controladas.
    - Test positivo para el virus de inmunodeficiencia humano (VIH).
    - Mujeres embarazadas o en periodo de lactancia.

    Cohorte B
    - Más de una línea previa de quimioterapia para la enfermedad local, incluyendo trabectedina.
    - Radioterapia en el lecho tumoral
    - Estado funcional ?2 (ECOG)
    -Presencia de metástasis o afectación ganglionar del tumor primario
    -Localización que no sea en extremidades o en la superficie de la pared torácica.
    -Bilirrubina plasmática > Límite superior de normalidad (LSN)
    -Creatinina > 1.6mg/dl
    - History of other neoplastic disease with the exception of basal cell carcinoma or in situ cervical cancer adequately treated.
    - Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
    - Significant systemic diseases grade 3 or higher on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
    - Uncontrolled bacterial, mycotic or viral infections.
    - Known positive test for infection by human immunodeficiency virus (HIV).
    - Women who are pregnant or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of RECIST criteria
    Evaluación por criterios RECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    For phase I and II of cohort A, the imaging evaluation will be performed at baseline and every 6 weeks until disease progression.
    For phase I and II of cohort B, the imaging evaluation to assess response following RECIST criteria, will be performed at baseline, week 10 from starting treatment and at follow up: MRI every 4 months in 1st year, every 6 months during 2nd and 3rd year; Thorax/Abdo CT scan will be performed every 4 months during 3 years.
    Para la fase I y II de la cohorte A, se realizarán pruebas de imagen en el periodo basal y cada 6 semanas hasta progresión de la enfermedad.

    Para la fase I y II de la cohorte B, se realizarán pruebas de imagen para valorar respuesta por RECIST en el periodo basal, en la semana 10 desde el inicio del tratamiento y en las visitas de seguimiento: Resonancia magnética cada 4 meses durante el primer año, cada 6 meses durante el segundo y el tercer año. Un TAC se realizará cada 4 meses durante tres años.
    E.5.2Secondary end point(s)
    Cohort A:
    - Assessment of adverse events following CTCAE v4.03
    - Progression Free survival, Overall Survival, potential predictive/prognostic biomarkers.
    - CHOI criteria response
    - QLQ-C30 EORTC questionnaire

    Cohort B:
    -Assessment of adverse events following CTCAE v4.03
    - Activity assessed by Functional imaging, pathologic response and potential predictive/prognostic biomarkers.
    -Recurrence free survival
    -CHOI criteria Response
    -QLQ-C30 EORTC questionnaire
    Cohorte A:
    - Evaluación de acontecimientos adversos por CTCAE v4.03
    -Supervivencia libre de progresión, supervivencia global, biomarcadores potenciales predictivos/de pronóstico
    -Respuesta según criterios CHOI
    -Cuestionarios QLQ-C30

    Cohorte B:
    -Evaluación de acontecimientos adversos por CTCAE v4.03
    - Actividad evaluada a través de Imagen Funcional, respuesta patológica y biomarcadores potenciales predictivos/de pronóstico.
    - Supervivencia libre de recaída.
    - respuesta segun Criterios CHOI
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Adverse events will be evaluated at the beginning of each cycle prior to treatment, and end of treatment
    -For phase I and II of cohort A, the imaging evaluation will be performed at baseline and every 6 weeks until disease progression.
    For phase I and II of cohort B, the imaging evaluation to assess response following RECIST criteria, will be performed at baseline, week 10 from starting treatment and at follow up: MRI every 4 months in 1st year, every 6 months during 2nd and 3rd year; Thorax/Abdo CT scan will be performed every 4 months during 3 years.
    - tumor collection and blood extractions.
    -Questionnaires in cohort A will be done at baseline, and every 3 cycles until end of treatment; cohort B at baseline, week 10 from beginning of treatment and at end of treatment.
    -Acontecimientos adversos serán evaluados al comienzo de cada ciclo antes de cada tratamiento y en la visita basal, asi como la visita final de tratamiento
    -Fase I,II cohorte A: pruebas de imagen: periodo basal y cada 6 semanas hasta progresión de la enfermedad.
    Fase I,II cohorte B: pruebas de imagen en el periodo basal, en la semana 10 desde el inicio del tratamiento y en las visitas de seguimiento: Resonancia magnética cada 4 meses durante el primer año, cada 6 meses durante el segundo y el tercer año. Un TAC se realizará cada 4 meses durante tres años.
    - Se extraerán muestras de sangre, y se recogeran muestras de tumor.
    -Los cuestionarios en cohorte A: basal, y cada tres semanas hasta fin de tratamiento. Cohorte B: basal, semana 10 y fin de tratamiento
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    trial to evaluate the potentially synergist effect for combination of trabectedin and radiotherapy
    Ensayo que evalua el efecto sinérgico de la combinacion de trabectedina con radioterapia
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 96
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 96
    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 Decision2014-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-21
    P. End of Trial
    P.End of Trial StatusOngoing
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