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    Summary
    EudraCT Number:2018-001201-93
    Sponsor's Protocol Code Number:CABOPRE
    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:2018-08-02
    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 number2018-001201-93
    A.3Full title of the trial
    Phase II study for the evaluation of neoadjuvant treatment with cabozantinib prior to cytoreductive nephrectomy in patients with locally advanced or metastatic renal cell carcinoma
    Estudio de fase II para la evaluación del tratamiento neoadyuvante con cabozantinib previo a la nefrectomía citorreductora en pacientes con cáncer de células renales localmente avanzado o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial for the evaluation of a new drug (cabozantinib) treatment given before having kidney surgery in patients with kidney cancer that is advanced or has spread
    Ensayo clínico para la evaluación de un nuevo tratamiento farmacológico (cabozantinib) administrado antes de una cirugía renal en pacientes con cáncer de riñón que está avanzado o se ha diseminado
    A.3.2Name or abbreviated title of the trial where available
    CABOPRE
    CABOPRE
    A.4.1Sponsor's protocol code numberCABOPRE
    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 SponsorFundación ONCOSUR
    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 supportIpsen Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación ONCOSUR
    B.5.2Functional name of contact pointPLATAFORMA DE ENSAYOS CLÍNICOS
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Córdoba s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number34628 88 64 20
    B.5.6E-mailsecretaria_tecnica@oncosur.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 Cabometyx
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCabometyx
    D.3.2Product code XL184
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCABOZANTINIB
    D.3.9.1CAS number 849217-68-1
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 60
    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
    Locally Advanced or Metastatic Renal Cell Carcinoma
    Cáncer de células renales localmente avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    Patients with Kidney Cancer that is advanced or that has spread.
    Pacientes con cáncer de riñón avanzado o que se ha extendido
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of preoperative treatment with cabozantinib (Cabometyx), measured by the radiological response rate prior to cytoreductive nephrectomy, in patients with advanced or metastatic renal cell carcinoma who are candidates for cytoreductive nephrectomy .
    Evaluar la eficacia del tratamiento preoperatorio con cabozantinib (Cabometyx), medida como la tasa de respuesta radiológica previa a la cirugía citorreductora (NC) en pacientes con cáncer de células renales avanzado o metastásico candidatos a NC.
    E.2.2Secondary objectives of the trial
    -To evaluate radiological response rates during treatment with cabozantinib in patients with advanced or metastatic renal cell carcinoma who are candidates for cytoreductive nephrectomy (NC).

    -To evaluate progression-free survival in patients undergoing CN after treatment with cabozantinib.

    -To evaluate overall survival in patients undergoing CN after a 12-week course of treatment with cabozantinib.

    -To evaluate the safety and tolerance of cabozantinib when administered before cytoreductive surgery, on the basis of the incidence and intensity of treatment-related adverse events reported during the study and classified according to the NCI CTCAE v4.03, and surgical complications according to the Clavien-Dindo classification system.

    -To evaluate changes in serum molecular markers of renal cell carcinoma associated with cabozantinib treatment in patients who are candidates for CN.
    -Evaluar la tasa de respuesta radiológica durante el tratamiento con cabozantinib en pacientes con cáncer de células renales avanzado o metastásico candidatos a cirugía citorreductora (NC).

    -Evaluar la supervivencia libre de progresión en pacientes sometidos a NC tras un tratamiento con cabozantinib.

    -Evaluar la supervivencia global en pacientes sometidos a NC tras un tratamiento de 12 semanas con cabozantinib.

    -Evaluar la seguridad y tolerabilidad de cabozantinib cuando se administra antes de la cirugía citorreductora, en base a la incidencia e intensidad de los acontecimientos adversos relacionados con el tratamiento notificados durante el estudio y clasificados según la CTCAE del NCI v4.03, así como las complicaciones quirúrgicas según la evaluación del sistema de clasificación de Clavien-Dindo.

    -Evaluar los cambios en los marcadores moleculares séricos del cáncer de células renales asociados al tratamiento con cabozantinib en pacientes candidatos a una NC.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To improve understanding of the mechanism of action of cabozantinib.

    - To evaluate the relationship between the expression of c-MET in tissue, c-MET in tumor-derived exosomes, and cabozantinib effectiveness.

    - To improve understanding and knowledge of the biology of the disease and response to the drug. For these purposes, analyses performed during the study will include:
    o Determination of tumor exome, transcriptome, and proteome.
    -Entender mejor el mecanismo de acción de cabozantinib.

    -Evaluar la relación entre la expresión de C-MET tisular, C-MET en exosomas
    derivados del tumor y la eficacia del cabozantinib.

    -Incrementar el conocimiento y la compresión de la biología de la enfermedad y la respuesta al fármaco. Para ello se realizarán los siguientes análisis (entre otros):
    o Determinación del exoma tumoral, transcriptoma y proteoma
    E.3Principal inclusion criteria
    Patients must meet the following inclusion criteria:

    1. Patients with locally advanced or metastatic renal cell carcinoma with a clear cell component confirmed histologically by biopsy.

    2. Patients eligible for CN according to their surgical risk established in routine clinical practice at the center.

    3. Age ≥ 18 years.

    4. Patients with an ECOG performance status of between 0 and 1.

    5. Patients with appropriate organ and bone marrow function within 4 weeks prior to starting treatment with cabozantinib:
    o Leukocyte count > 4,000 cells/µL
    o Hemoglobin > 9 g/dL
    o Platelet count > 100,000/mm3
    o Serum creatinine < 2.0 mg/dL or serum creatinine clearance > 30 mL/min (according to the Cockcroft-Gault formula (Cockcroft and Gault 1976).
    o Preserved liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) in the absence of liver metastases; < 5 x ULN in the case of liver metastases.
    o Lipase < 2 x ULN. Amilase < 2 x LSN
    o INR and APTT ≤ 1.5 x ULN of the center. This only applies to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation with low molecular weight heparins should maintain stable doses.

    6. Patients with no radiological or clinical evidence of pancreatitis.

    7. Patients with evaluable tumor disease according to the RECIST criteria 1.1 (Eisenhauer et al. 2009).

    8. Patients with controlled blood pressure (systolic < 145 mmHg; diastolic blood pressure < 90 mmHg).

    9. Patients who sign informed consent to participate in the study.

    10. Patients may have brain metastases appropriately treated with radiation therapy and/or surgery (including radiosurgery), as long as they do not require the concomitant use of corticosteroids.
    Los pacientes deben cumplir los siguientes criterios de inclusión:

    1. Pacientes con cáncer de células renales localmente avanzado o metastásico con un componente de células claras confirmado histológicamente mediante biopsia.

    2. Pacientes aptos para una cirugía citorreductora (NC) de acuerdo con el riesgo quirúrgico establecido en la práctica clínica habitual del centro.

    3. Edad ≥ 18 años.

    4. Pacientes con un estado funcional ECOG de entre 0 y 1.

    5. Pacientes con una función orgánica y de médula ósea adecuadas dentro de las 4 semanas previas al inicio del tratamiento con cabozantinib:
    o Recuento de leucocitos > 4.000 células/μL
    o Hemoglobina > 9 g/dL
    o Recuento de plaquetas > 100.000/mm3
    o Creatinina sérica < 2,0 mg/dL o aclaramiento de la creatinina sérica > 30
    mL/min (según la fórmula de Cockcroft-Gault (Cockcroft and Gault 1976)).
    o Función hepática preservada: alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) < 2,5 x límite superior de la normalidad (LSN) en ausencia de metástasis hepáticas; < 5 x LSN en el caso de metástasis hepáticas.
    o Lipasa < 2 x LSN. Amilasa < 2 x LSN .
    o INR y TTPA ≤ 1,5 vece el LSN del centro. Esto solo aplica a pacientes que no reciban anticoagulación terapéutica; los pacientes que reciban
    anticoagulación terapéutica con heparinas de bajo peso molecular deben mantener dosis estables.

    6. Pacientes sin evidencia radiológica o clínica de pancreatitis.

    7. Pacientes con enfermedad neoplásica evaluable según los criterios RECIST 1.1 (Eisenhauer et al. 2009).

    8. Pacientes con tensión arterial controlada (sistólica < 145 mmHg; diastólica < 90 mmHg).

    9. Pacientes que firman el consentimiento informado para participar en el estudio.

    10. Los pacientes pueden tener metástasis cerebrales adecuadamente tratadas con radioterapia y/o cirugía (incluyendo radiocirugía), siempre y cuando no requieran el uso concomitante de corticoesteroides.
    E.4Principal exclusion criteria
    1. Patients with a second active malignant tumor.

    2. Patients with tumors treated in the last 2 years.

    3. Pregnant or breast-feeding women.

    4. Women of child-bearing potential who do not agree to use a contraceptive method during treatment. Women participating in the study should have undergone surgical sterilization, be post-menopausal, or agree to use a highly effective contraceptive method (in accordance with CTFG criteria) during the treatment period. Both patients of both sexes and their partners must use effective contraception during treatment and, at least, up to four months after completing treatment. Since oral contraceptives can not possibly be considered "effective contraceptive methods", they should be used in conjunction with another method, such as a barrier method.

    5. Fertile men who do not agree to use a contraceptive method during treatment. Male participants in the study should have undergone surgical sterilization, or agree to use a highly effective contraceptive method (in accordance with CTFG criteria) during the treatment period.

    6. Patients with gastrointestinal disorders, including:
    o Inability to take oral medication.
    o Need for parenteral nutrition.
    o Prior surgical procedures affecting absorption.
    o Active gastrointestinal bleeding.
    o Malabsorption syndrome.
    o Gastrointestinal disorders that increase the risk of perforation.

    7. Patients who have had any of the following conditions within the 12 months prior to inclusion in the study: myocardial infarction, uncontrolled angina, uncontrolled hypertension, peripheral arterial or coronary graft bypass, congestive heart failure, stroke, or transient ischemic attack.

    8. Patients with tumors that invade or affect major blood vessels, gastrointestinal tract, or trachea/bronchi.

    9. Patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases.

    10. Patients with active hepatitis or hepatitis C.

    11. Patients with active tuberculosis.

    12. Patients with uncontrolled (Ca > 12 mg/dL) or symptomatic hypercalcemia who require continuous treatment with bisphosphonates or denosumab.

    13. Patients who have undergone major surgery within 4 weeks prior to inclusion in the study.

    14. Patients with active bleeding.

    15. Patients with a recent episode of intestinal obstruction.

    16. Patients who have previously received VEGF growth factor-targeted therapy for advanced disease.

    17. Patients who have undergone radiation therapy for bone metastases within 2 weeks prior to the first dose of cabozantinib, or any external radiation therapy within 4 weeks prior to the first dose of cabozantinib.

    18. Patients who have received an allogeneic transplant or stem cells in the last 5 years.

    19. Malignant tumors within 3 years before Day 1 of Cycle 1, except for those with negligible risk of metastasis or death and who have been treated with curative intent, such as cervical carcinoma in situ or localized prostate cancer treated with curative intent.

    20. Patients receiving therapeutic doses of oral anticoagulants (e.g., warfarin, direct thrombin inhibitors and Factor Xa) or antiplatelet agents (e.g., clopidogrel). The use of low molecular weight heparins is allowed.

    21. Hypersensitivity to the active substance or to any of the excipients (exclude lactose intolerant patients since each film-coated tablet contains 46.61 mg of lactose)

    22. Any other clinical condition that the physician responsible for the patient considers to be inappropriate for inclusion in the study.
    1. Pacientes con un segundo tumor maligno activo.

    2. Pacientes con tumores tratados en los últimos 2 años.

    3. Mujeres embarazadas o lactantes.

    4. Mujeres en estado fértil que no acepten utilizar método contraceptivo durante el tratamiento. Las mujeres participantes en el estudio deberán haberse sometido a esterilización quirúrgica, estar en estado post-menopáusico o aceptar el uso de un método contraceptivo de alta eficacia [de acuerdo con los criterios del CTFG (CTFG2014)] durante el periodo de tratamiento. Tanto los pacientes de ambos sexos como sus parejas deben usar métodos anticonceptivos eficaces durante el tratamiento y, como mínimo, hasta cuatro meses después de completar el tratamiento. Dado que los anticonceptivos orales posiblemente no pueden considerarse “métodos anticonceptivos eficaces”, deben utilizarse junto con otro método, como un método de barrera.

    5. Hombres en estado fértil que no acepten utilizar método contraceptivo durante el tratamiento. Los hombres participantes en el estudio deberán haberse sometido a esterilización quirúrgica o aceptar el uso de un método contraceptivo de alta eficacia
    [de acuerdo con los criterios del CTFG (CTFG 2014)] durante el periodo de tratamiento.

    6. Pacientes con alteraciones gastrointestinales, incluyendo:
    o Incapacidad para tomar medicación oral.
    o Necesidad de nutrición parenteral.
    o Procedimientos quirúrgicos previos que afecten la absorción.
    o Sangrado gastrointestinal activo.
    o Síndrome de malabsorción.
    o Alteraciones gastrointestinales que incrementen el riesgo de perforación.

    7. Pacientes que hayan sufrido cualquiera de las siguientes condiciones dentro de los 12 meses previos a su inclusión en el estudio: infarto de miocardio, angina no controlada, hipertensión no controlada, bypass mediante injerto arterial periférico o coronario, insuficiencia cardiaca congestiva, accidente cerebrovascular o accidente isquémico transitorio.

    8. Pacientes con tumores que invadan o afecten vasos sanguíneos mayores, el tracto gastrointestinal o la tráquea/bronquios.

    9. Pacientes infectados con el virus de la inmunodeficiencia humana (VIH) o enfermedades relacionadas con el síndrome de inmunodeficiencia adquirida (SIDA).

    10. Pacientes con hepatitis activa o con hepatitis C.

    11. Pacientes con tuberculosis activa.

    12. Pacientes con hipercalcemia no controlada (Ca > 12mg/dL) o sintomática que requiera tratamiento ininterrumpido con bifosfonatos o denosumab.

    13. Pacientes sometidos a cirugía mayor dentro de las 4 semanas previas a la inclusión en el estudio.

    14. Pacientes con hemorragias activas.

    15. Pacientes con algún episodio reciente de obstrucción intestinal.

    16. Pacientes con con alguna terapia previa dirigida al factor de crecimiento VEGF para enfermedad avanzada.

    17. Pacientes sometidos a radioterapia para las metástasis óseas durante las 2 semanas previas a la primera dosis de cabozantinib o sometidos a cualquier radioterapia externa dentro de las 4 semanas previas a la primera dosis de cabozantinib.

    18. Pacientes que hayan recibido un trasplante alogénico o células madre en los últimos 5 años.

    19. Neoplasias malignas en los 3 años anteriores al día 1 del ciclo 1, a excepción de los que tengan riesgo insignificante de metástasis o muerta y hayan sido tratados con intención curativa como el carcinoma in situ de cuello uterino o cáncer de próstata localizado tratado con intención curativa.

    20. Pacientes que reciben un tratamiento anticoagulante a dosis terapéuticas con anticoagulantes orales (p. ej., warfarina, inhibidores directos de la trombina y del Factor Xa) o antiagregantes plaquetarios (p. ej., clopidogrel). El uso de heparinas de bajo peso molecular está permitido.

    21. Hipersensibilidad al principio activo o a alguno de los excipientes (excluir a los pacientes intolerantes a la lactosa ya que cada comprimido recubierto con película contiene 46,61 mg de lactosa).

    22. Cualquier otra condición clínica que considere el médico responsable del paciente como inadecuado para la inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response to preoperative treatment with cabozantinib, defined as the percentage of patients that reach a total or partial radiological response after a 12-week course of treatment with cabozantinib, defined according to the RECIST 1.1 criteria (Eisenhauer et al., 2009)
    Respuesta objetiva al tratamiento preoperatorio con cabozantinib, definida como el porcentaje de pacientes que alcanzan una respuesta radiológica total o parcial a las 12 semanas de iniciar el tratamiento con cabozantinib, definidas de acuerdo con los criterios RECIST 1.1 (Eisenhauer et al. 2009)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After a 12-week course of treatment with cabozantinib (visit 2)
    A las 12 semanas de iniciar el tratamiento con cabozantinib (visita 2)
    E.5.2Secondary end point(s)
    1. Better objective response during treatment with cabozantinib, defined as the percentage of patients that reach a total or partial radiological response during treatment with cabozantinib.

    2. Progression Free Survival, defined as the time (in months) elapsed since the start of treatment
    with cabozantinib until the progression of the disease (according to the RECIST criteria 1.1) or the death of the patient.

    3. Percentage of patients free of progression (according to the RECIST criteria1.1) after 12 months from the start of treatment with cabozantinib.

    4. Overall Survival, defined as the time (in months) elapsed since the start of treatment with cabozantinib until the death of the patient.

    5. Frequency of adverse events related to cabozantinib registered during the study.

    6. Variation in the concentration of biomarkers from the beginning of treatment with cabozantinb until its completion.
    Endpoints secundarios
    1. Mejor respuesta objetiva durante el tratamiento con cabozantinib, definida como el porcentaje de pacientes que alcanzan una respuesta radiológica total o parcial durante el tratamiento con cabozantinib.

    2. Supervivencia Libre de Progresión, definida como el tiempo (en meses) transcurrido desde el inicio de tratamiento con cabozantinib hasta la progresión de la enfermedad (de acuerdo con los criterios RECIST 1.1) o el fallecimiento del paciente.

    3. Porcentaje de pacientes libres de progresión (de acuerdo con los criterios RECIST 1.1) tras 12 meses del inicio del tratamiento con cabozantinib.

    4. Supervivencia Global, definida como el tiempo (en meses) transcurrido desde el inicio del tratamiento con cabozantinib hasta el fallecimiento del paciente.

    5. Frecuencia de acontecimientos adversos relacionados con cabozantinib registrados durante el estudio.

    6. Variación de la concentración de los biomarcadores desde el inicio del tratamiento con cabozantinb hasta su finalización.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During all study

    2. During all study

    3. Final Visit (12 months from the start of treatment with cabozantinib)

    4. During all study

    5. During all study

    6. Basal Visit, D1C1, D1C3, D1C4, Final Visit (12 months from the start of treatment with cabozantinib)
    1. Durante todo el estudio

    2. Durante todo el estudio

    3. Visita Final (12 meses del inicio del tratamiento con cabozantinib)

    4. Durante todo el estudio

    5. Durante todo el estudio

    6. Visita Basal, D1C1, D1C3, D1C4, Visita Final (12 meses del inicio del tratamiento con cabozantinib)
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned5
    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 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
    Last Patient Last Visit
    La fecha de final del ensayo será la última visita del último paciente.
    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 months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    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)
    Once patient ended the particpation in the trial she/he will receive expected normal treatment for her/his condition.
    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 Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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