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    Summary
    EudraCT Number:2016-003946-99
    Sponsor's Protocol Code Number:GETHI021
    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:2017-03-31
    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 number2016-003946-99
    A.3Full title of the trial
    A multicenter phase 2 study of nivolumab combined with ipilimumab in patients with pediatric solid tumors presenting in adulthood
    Estudio multicéntrico, fase 2 de nivolumab en combinación con ipilimumab para pacientes con tumores pediátricos sólidos avanzados del adulto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter phase 2 study of nivolumab combined with ipilimumab in patients with pediatric solid tumors presenting in adulthood
    Estudio multicéntrico, fase 2 de nivolumab en combinación con ipilimumab para pacientes con tumores pediátricos sólidos avanzados del adulto
    A.4.1Sponsor's protocol code numberGETHI021
    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 SponsorGrupo Español de Tumores Huérfanos e Infrecuentes (GETHI)
    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 supportBristol Mayer
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L
    B.5.2Functional name of contact pointMarta Domínguez
    B.5.3 Address:
    B.5.3.1Street AddressC/ Azcona 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number003491456 11 05
    B.5.5Fax number003491456 11 24
    B.5.6E-mailm.dominguez@dynasolutions.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 Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNivolumab
    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 INNNivolumab
    D.3.9.1CAS number EU/1/15/1014
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    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 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 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 Yes
    D.2.1.1.1Trade name Yervoy
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    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 INNIPILIMUMAB
    D.3.9.1CAS number EU/1/11/698/
    D.3.9.2Current sponsor codeBMS-734016
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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
    Pediatric solid tumors presenting in adulthood
    Tumores pediátricos sólidos avanzados del adulto
    E.1.1.1Medical condition in easily understood language
    Pediatric solid tumors presenting in adulthood
    Tumores pediátricos sólidos avanzados del adulto
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall response rate
    Tasa de respuesta global (TRG)
    E.2.2Secondary objectives of the trial
    - Progression free survival.
    - Overall survival.
    - Disease control rate.
    - Duration of overall response.
    - Time to progression.
    - Time to treatment failure .
    - Time to objective response .
    - Toxicity profile of the combination of Nivolumab and Ipililumab.
    - Quality of life (QoL) along treatment.
    Translational research Objetives:
    - Association between PD-1 and PD-L1 expression in tumor, with the activity of nivolumab and ipilimumab combination.
    - Association between germline coding SNPs and regulatory SNPs with the activity of nivolumab and ipilimumab combination.
    -Association between tumor neoepitopes, determined through WES of tumor DNA, with clinical activity of nivolumab and ipilimumab combination. Additionally, mutational patterns in responders and non-responders will be explored.
    -Association between the degree of activation of lymphocytes, extracted from peripheral blood of patients in this trial, with real clinical activity of nivolumab and ipilimumab combination.
    -Supervivencia sin progresión
    -Supervivencia global
    -Tasa de control de la enfermedad
    -Tiempo transcurrido hasta la respuesta
    -Duración de la respuesta global
    -Tiempo transcurrido hasta la progresión
    -Tiempo transcurrido hasta el fracaso del tratamiento
    -Perfil de toxicidad de la politerapia con nivolumab e ipilimumab
    -La calidad de vida
    Objetivos exploratorios:
    -Evaluar la relación entre el grado de expresión del PD-1 y el PD-L1 en el tumor con la actividad de la politerapia con nivolumab e ipilimumab
    - Evaluar la relación entre los polimorfismos mononucleotídicos de estirpe germinal codificadores y reguladores y la actividad de la politerapia con nivolumab e ipilimumab
    -Evaluar la relación entre los neoepítopos tumorales y la actividad de la politerapia con nivolumab e ipilimumab.
    - Evaluar la relación entre el grado de activación de los linfocitos extraídos de la sangre periférica con la actividad clínica real de la politerapia con nivolumab e ipilimumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be ≥ 18 years of age, and any subjects of any gender is allowed.

    2. Subjects must have histologically confirmed diagnosis of unresectable, recurrent, and/or metastatic childhood malignancies:
    a. Medulloblastoma
    b. Hepatoblastoma
    c. Neuroblastoma
    d. Wilms’ tumor
    e. Retinoblastoma
    f. Pinealoblastoma
    g. Pancreatoblastoma
    h. Askin’s tumor and Ewing family of tumors
    i. Langerhans cell histiocytosis
    j. Other pediatric malignancies: to be discussed with steering comitee.

    3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤2.

    4. Subjects must have at least one site of measurable/evaluable disease on CT/MRI scans. Baseline imaging must be performed within 30 days of Day 1 of study.

    5. Patients may have received prior standard therapy as defined by the attending physician for every tumor subtype. Cases not candidate for standard therapies will be allowed in the trial, according to the attending physician criteria. Additionally those tumors where standard therapy does not exist will be also eligible.

    6. Subjects must have adequate electrolyte values, bone marrow, renal and liver functions at screening as defined below:
    a. WBC ≥ 2 x 109/L
    b. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    c. Platelets ≥ 100 x 109/L
    d. Hemoglobin ≥ 9.0 g/dL
    e. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) 40 mL/min (if using Crockcroft-Gault formula below):
    i. Female CrCl = (140 – age in years) x weight in kg x 0.85
    72 x serum creatinine in mg/dL
    ii. Male CrCl = (140 – age in years) x weight in kg x 1.00
    72 x serum creatinine in mg/dL
    f. Total Bilirubin ≤ 2 x ULN (unless elevated secondary to benign
conditions such as Gilbert’s disease, who can have total bilirrubine < 3.0 mg/dL)
    g. AST and ALT ≤ 3 x ULN (except patient with liver metastasis who can have values ≤ 5 x ULN)

    7. Subjects must be capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening study-specific procedures.

    8. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab.

    9. Women of childbearing potential (WOCBP) must agree to use appropriate and effective method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy from Day 1 of study and for 5 months (time required for nivolumab to undergo 6,1 half-lives) after the last dose of investigational drug administration. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. These durations have been calculated using the upper limit of the half-life for nivolumab and are based on the protocol requirement that WOCBP use contraception for 6,1 half-lives and men who are sexually active with WOCBP use contraception for 8,5 half-lives. Effective methods of birth control include:
    a. total abstinence from sexual intercourse (if it is the subject’s preferred and usual lifestyle; for beginning a minimum one complete menstrual cycle prior to study drug administration and to extend 6 months after treatment);
    b. vasectomized subject or partner(s); vasectomy (males);
    c. intrauterine device (IUD) (females)
    d. double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams; both males and females);
    e. hormonal contraceptives (oral, parenteral or transdermal) for at least 90 days prior to study drug administration (females). If hormonal contraceptives are used, the subject and her partner should also use a single-barrier method.

    10. Life expectancy of >12 weeks.

    11. Patients with primary cancers outside central nervous system with central nervous system disease are eligible for enrolment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression for at least 4 weeks prior to study entry, have no evidence of new or enlarging brain metastases, and are off steroids for at least 7 days before first dose of nivolumab and ipilimumab.
    E.4Principal exclusion criteria
    1. Subjects should be excluded if they have had prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.

    2. Subjects who are curable by conventional multidisciplinary management.

    3. Subjects with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.

    4. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to Day 1 of study or who have not recovered adequately from side effects of such therapy.

    5. Subjects who have active infections requiring therapy.

    6. Subjects should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.

    7. Subjects should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

    8. Subjects that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.

    9. Subjects who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:
    a. Subjects who have received cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment prior to starting study drug.
    b. Patients who have received biologic therapy within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug.
    c. Patients who have been treated with continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug.
    d. Patients who have received any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shorter) prior to starting study drug.

    10. Subjects who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug.

    11. Subjects who have undergone major surgery ≤ 2 weeks prior to starting study drug.

    12. Subjects with active, known or suspected autoimmune disease or a documented history of autoimmune disease.

    13. Women who are pregnant or nursing/breastfeeding.

    14. Subjects who have known hypersensitivity to nivolumab or ipilimumab or another mAb.

    15. Subjects with a history of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease.

    16. Subjects with untreated central nervous system disease.

    17. Subjects who have any inability to comply with protocol required procedures.

    18. Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

    19. Subjects who have received a live vaccine within 30 days prior to the first dose of trial treatment.

    20. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
    1.Debe excluirse a los pacientes que hayan recibido anteriormente tratamiento sistémico con un anticuerpo anti-PD-1, anti-PD-L1, anti-PD-L2 o anti-CTLA-4, o cualquier otro anticuerpo o fármaco que coestimule específicamente a los linfocitos T o actúe sobre las rutas de los puntos de control inmunitario.
    2.Pacientes que puedan curarse con el abordaje pluridisciplinar habitual.
    3.Pacientes que presenten de forma simultánea una enfermedad grave o sin controlar que, en opinión del investigador, pueda entrañar riesgos de seguridad inaceptables o poner en peligro el cumplimiento del protocolo.
    4.Pacientes que hayan recibido radioterapia de campo amplio ≤ 4 semanas o radioterapia de campo limitado con fines paliativos < 2 semanas antes del día 1 del estudio, o que no se hayan recuperado suficientemente de los efectos secundarios.
    5.Pacientes que presenten infecciones activas que requieran tratamiento.
    6.Debe excluirse a los pacientes que presenten resultados positivos en las pruebas del antígeno de superficie del virus de la hepatitis B (Ags VHB) o del ácido ribonucleico del virus de la hepatitis C (anticuerpos frente al VHC), lo que es indicativo de infección aguda o crónica.
    7.Debe excluirse a los pacientes que anteriormente hayan presentado un resultado positivo en las pruebas del virus de la inmunodeficiencia humana (VIH) o presenten el síndrome de inmunodeficiencia adquirida (sida).
    8.Pacientes que presenten toxicomanía o un trastorno psiquiátrico, que interferiría en el cumplimiento de los requisitos del ensayo.
    9.Pacientes que hayan recibido tratamiento antineoplásico sistémico antes de la primera dosis del fármaco del estudio, en los plazos que se indican a continuación:
    a.Pacientes que hayan recibido quimioterapia cíclica en el transcurso de un período de tiempo inferior a la duración del ciclo que se siga para ese tratamiento, respecto al inicio de la administración del fármaco del estudio.
    b.Pacientes que hayan recibido tratamiento biológico en el transcurso de un período de tiempo que sea ≤ 5 veces la semivida de eliminación (t1/2) respecto al inicio de la administración del fármaco del estudio o ≤ 4 semanas antes del inicio de dicha administración (lo que sea inferior).
    c.Pacientes que hayan recibido tratamiento continuo o intermitente con fármacos de molécula pequeña, en el transcurso de un período de tiempo que sea ≤ 5 veces la semivida de eliminación (t1/2) respecto al inicio de la administración del fármaco del estudio o ≤ 4 semanas antes del inicio de dicha administración (lo que sea inferior).
    d.Pacientes que hayan recibido cualquier otro fármaco en investigación en el transcurso de un período de tiempo que sea ≤ 5 veces la semivida de eliminación o inferior al ciclo que se siga para ese tratamiento respecto al inicio de la administración del fármaco del estudio o ≤ 4 semanas antes del inicio de dicha administración (lo que sea inferior).
    10.Pacientes que hayan recibido radioterapia de campo amplio (incluidos radioisótopos terapéuticos como el estroncio 89) ≤ 4 semanas o radioterapia de campo limitado con fines paliativos < 2 semanas antes del inicio de la administración del fármaco del estudio.
    11.Pacientes que se hayan sometido a una intervención de cirugía mayor ≤ 2 antes del inicio de la administración del fármaco del estudio.
    12.Pacientes con enfermedad autoinmunitaria activa (confirmada o sospechada) o antecedentes documentados de enfermedad autoinmunitaria.
    13.Mujeres embarazadas o en período de lactancia.
    14.Pacientes con hipersensibilidad a nivolumab, ipilimumab o a otro AcM.
    15.Pacientes con antecedentes de neumonitis no infecciosa que hayan requerido una tanda de tratamiento con corticoesteroides orales o intravenosos para su recuperación, o con enfermedad pulmonar intersticial.
    16.Pacientes que presenten enfermedad del sistema nervioso central sin tratar.
    17.Pacientes que sean incapaces de cumplir los procedimientos requeridos del protocolo.
    18.Debe excluirse a los pacientes que presenten una enfermedad que requiera tratamiento sistémico con corticoesteroides (> 10 mg/día de prednisona [o equivalente]) u otros medicamentos inmunodepresores, en el transcurso de los 14 días anteriores a la administración del fármaco del estudio. Se permite la administración de corticoesteroides por vía inhalada o tópica y tratamiento de reposición suprarrenal en dosis > 10 mg diarios de prednisona (o equivalente), si el paciente no presenta una enfermedad autoinmunitaria activa.
    19.Pacientes que hayan recibido una vacuna elaborada con microbios vivos en el transcurso de los 30 días anteriores a la primera dosis del tratamiento.
    20.Pacientes con neoplasias malignas previas que hayan estado activas en el transcurso de los 3 años anteriores, salvo los tumores malignos que puedan curarse localmente y aparentemente se hayan curado, como el cáncer de piel de células escamosas o basales, el cáncer superficial de la vejiga o el carcinoma in situ de próstata, cuello uterino o mama
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR)
    Tasa de respuesta global (TRG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 9 weeks since start o treatment.
    Cada 9 semanas desde inicio de tratamiento.
    E.5.2Secondary end point(s)
    - Progression free survival.
    - Overall survival.
    - Disease control rate.
    - Duration of overall response.
    - Time to progression.
    - Time to treatment failure .
    - Time to objective response .
    - Toxicity profile of the combination of Nivolumab and Ipililumab.
    - Quality of life (QoL) along treatment.
    Translational research Objetives:
    - To identify molecular profiles able to predict patient response to treatment in terms of both efficacy and toxicity.
    -Supervivencia sin progresión
    -Supervivencia global
    -Tasa de control de la enfermedad
    -Tiempo transcurrido hasta la respuesta
    -Duración de la respuesta global
    -Tiempo transcurrido hasta la progresión
    -Tiempo transcurrido hasta el fracaso del tratamiento
    -Perfil de toxicidad de la politerapia con nivolumab e ipilimumab
    -La calidad de vida
    Objetivos exploratorios:
    - Identificar perfiles moleculares que permiten predecir la respuesta de los pacientes al tratamiento desde el punto de vista de eficacia y la toxicidad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuosly through the study visits
    A lo largo de las distintas visitas 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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    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 concerned15
    E.8.5The trial involves multiple Member States No
    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
    End of the trial will be consider database lock
    Fin de estudio se considerará fecha cierre base de datos
    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 months
    E.8.9.1In the Member State concerned days
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state98
    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)
    Standard of care
    Práctica clínica habitual
    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 Decision2017-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
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