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    Summary
    EudraCT Number:2013-005428-41
    Sponsor's Protocol Code Number:02044190615-01
    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:2014-11-04
    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 number2013-005428-41
    A.3Full title of the trial
    Phase III study of RegorAfenib VErsus placebo as maintenance therapy in RAS wiLd type metastatic coLOrectal cancer
    Estudio de fase III de regorafenib frente a placebo como terapia de mantenimiento tras un tratamiento de primera línea del cáncer colorrectal metastásico con RAS de tipo natural (ensayo RAVELLO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    maintenance therapy with regorafenib
    Terapia de mantenimiento con regorafenib
    A.3.2Name or abbreviated title of the trial where available
    RAVELLO
    RAVELLO
    A.4.1Sponsor's protocol code number02044190615-01
    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 SponsorDepartment of experimental and clinical medicine "F. Magrassi"
    B.1.3.4CountryItaly
    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 supportDepartment of experimental and clinical medicine Department of experimental and clinical medicine "F.Magrassi"
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportBayer
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartamento de medicina experimental y clinica "F. Magrassi"
    B.5.2Functional name of contact pointProf. Dr. Fortunato Ciardiello
    B.5.3 Address:
    B.5.3.1Street AddressVia Pansini 5
    B.5.3.2Town/ cityNaples
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number+34914328960
    B.5.5Fax number+390815666732
    B.5.6E-mailfortunato.ciardiello@unina2.it
    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 Stivarga
    D.2.1.1.2Name of the Marketing Authorisation holderBayer
    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 nameStivarga
    D.3.4Pharmaceutical form 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 INNRegorafenib
    D.3.9.1CAS number 755037-03-7
    D.3.9.3Other descriptive nameREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The present proposal is aimed to evaluate the efficacy and safety of regorafenib as maintenance therapy in increasing the efficacy of the best available therapy for first line treatment fluoropirimidine based chemotherapy , any variant, in combination with either cetuximab or panitumumab) of RAS wild type metastatic colorectal cancer patients.
    El presente protocolo pretende evaluar la eficacia y seguridad de regorafenib como terapia de mantenimiento incrementando la eficacia de la mejor terapia disponible de primera linea de con quimioterapia basada en fluoropirimidinas (cualquier variante) en combinación con, bien cetuximab, o bien panitumumab, en pacientes con cáncer colorrectal metastásico.
    E.1.1.1Medical condition in easily understood language
    Regorafenib as maintenance therapy of RAS wild type metastatic
    colorectal cancer patients.
    Regorafenib como tratamiento de mantenimiento en pacientes con cáncer colorrectal metastásico con RAS de tipo natural.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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
    The objective of this study is to evaluate efficacy and safety of regorafenib in the maintenance of the response in patients with metastatic colorectal (CRC) RAS wild type after first line therapy
    (fluoropirimidine-based plus anti-EGFR Abs). The primary efficacy endpoint of this study is Progression Free Survival (PFS) defined as the time(days) from randomization for maintenance therapy with study drug to PD or death whichever comes first.
    El objetivo de este estudio es evaluar la eficacia y la seguridad del regorafenib en el mantenimiento de la respuesta en pacientes con cáncer colorrectal (CCR) metastásico con RAS de tipo natural tras el tratamiento de primera línea (basado en fluoropirimidinas más anticuerpos anti-EGFR).
    El criterio principal de valoración de la eficacia de este estudio es la supervivencia sin progresión (SSP), definida como el tiempo (días) desde la aleatorización al tratamiento de mantenimiento con el fármaco del estudio hasta la PE o la muerte, lo que suceda antes.
    E.2.2Secondary objectives of the trial
    - Overall survival (OS)
    - Safety Profile
    - Biomarker correlative studies
    - Supervivencia global (SG).
    - Perfil de seguridad.
    - Estudios correlativos de biomarcadores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent.
    ?Male or female patients >= 18 years
    ?Histological or cytological documentation of adenocarcinoma of the colon or rectum
    ?Genetic diagnosis of RAS(hot spot mutations KRAS codon 2-3-4 and NRAS at least codon 2-3) wild type tumor .
    ?Previous standard first line treatment defined as fluoropirimidine based chemotherapy (any variant) in combination with either cetuximab or panitumumab for a minimum of 4 months and a maximum of 8 months.
    ?Patients that have achieved either partial response (PR) , complete response (CR) or stable disease (SD) at the completion of the first line treatment after a minimum of 4 months (8 cycles) and a maximum of 8 months (16 cycles) .
    ?Patients with PR/SD must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, version 1.1).
    ?Eastern Cooperative Oncology Group (ECOG) Performance Status of ? 1.
    ?Life expectancy of at least 6months.
    ?Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
    o Total bilirubin < 1.5 x the upper limit of normal (ULN).
    o Alanine transaminase (ALT) and aspartate aminotransferase (AST) <3 x ULN (<5 x ULN for patients with liver involvement of their cancer).
    o Serum creatinine< 1.5 x the ULN.
    o Estimated creatinine clearance (CLcr) ? 30 mL/min as calculated using the Cockcroft-Gault equation.
    o INR/PTT < 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ? 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g. heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care.
    o Platelet count ¬> 100000 /mm3, Hemoglobin (Hb) > 9 g/dl, Absolute neutrophil count (ANC) > 1500/mm3
    o Alkaline phosphatase limit < 2.5 x ULN (<5 x ULN for patients with liver involvement of their cancer)
    o Lipase < 1.5 x ULN
    ?Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. The investigator or a designated associate is requested to advise the patient how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.
    ?Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment.
    - Obtención del consentimiento informado firmado antes de cualquier procedimiento específico del estudio. Los pacientes deben ser capaces de comprender un consentimiento informado por escrito y estar dispuestos a firmarlo.
    - Pacientes del sexo masculino o femenino >= 18 años
    - Documentación histológica o citológica de adenocarcinoma del colon o del recto
    - Diagnóstico genético de tumor de tipo RAS natural (mutaciones de punto caliente de KRAS en el codón 2-3-4 y de NRAS al menos en el codón 2-3).
    - Tratamiento de primera línea estándar previo, definido como quimioterapia basada en fluoropirimidinas (cualquier variante) en combinación con cetuximab o panitumumab durante un mínimo de 4 meses.
    - Pacientes que hayan logrado respuesta parcial (RP), respuesta completa (RC) o enfermedad estable (EE) después de la primera línea de entre un mínimo de 4 meses (8 ciclos) y un máximo de 8 (16 ciclos).
    - Los pacientes con RP/EE deben presentar enfermedad mensurable de acuerdo con los Criterios de Evaluación de la Respuesta en Tumores Sólidos (criterios RECIST, versión 1.1).
    - Estado funcional del Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, ECOG) <= 1.
    - Esperanza de vida de al menos 6 meses.
    - Función adecuada medular, hepática y renal según los siguientes resultados analíticos obtenidos en los 7 días previos al inicio del tratamiento del estudio:
    · Bilirrubina total <= 1,5 veces el límite superior de la normalidad (LSN).
    · Alanina transaminasa (ALT) y aspartato aminotransferasa (AST) <= 3 veces el LSN (<= 5 veces el LSN en los pacientes con afectación hepática por el cáncer).
    · Creatinina sérica <= 1,5 veces el LSN.
    · Aclaramiento de la creatinina (CLcr) estimado >= 30 ml/min, calculado con la
    ecuación de Cockcroft-Gault.
    · INR/TTP <= 1,5 veces el LSN y tiempo de tromboplastina parcial (TTP) o tiempo de tromboplastina parcial activada (TTPa) <= 1,5 veces el LSN a menos que reciban tratamiento con anticoagulación terapéutica. Los pacientes tratados con anticoagulantes, p. ej. heparina, podrán participar siempre que no haya evidencia previa de una anomalía subyacente en estos parámetros. Se llevará a cabo un estrecho control con evaluaciones al menos una vez por semana hasta que el INR y el TTP sean estables según una medición previa a la dosis definida por el procedimiento habitual en el centro.
    · Cifra de trombocitos >= 100.000/mm3, hemoglobina (Hb) 9 g/dl, cifra absoluta de neutrófilos (CAN) >= 1.500/mm3
    · Límite de la fosfatasa alcalina <= 2,5 veces el LSN (<= 5 veces el LSN en los
    pacientes con afectación hepática por el cáncer)
    ·Lipasa <= 1,5 veces el LSN
    - Las mujeres fértiles y los hombres deben acceder a usar un método anticonceptivo adecuado antes de entrar en el programa y al menos hasta 8 semanas después de la última administración del fármaco del estudio. Se solicita que el investigador o un auxiliar designado asesore al paciente sobre cómo lograr un control de la natalidad adecuado. Un método anticonceptivo válido se define en el estudio como cualquier método (o combinación de métodos) recomendado médicamente según el procedimiento habitual.
    - Las mujeres fértiles deben someterse a una prueba de embarazo en sangre u orina un máximo de 7 días antes del inicio del tratamiento del estudio, y debe documentarse un resultado negativo antes del inicio del tratamiento del estudio.
    E.4Principal exclusion criteria
    ?Prior treatment with regorafenib.
    ?Interruption of the first line treatment for progressive disease or in which progressive disease was diagnosed prior to entry into this study.
    ?Assumption of strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John?s Wort) (see Section 13.1)
    ?Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (Non invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
    ?Pregnant or breast-feeding patients. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
    ?Congestive heart failure > New York Heart Association (NYHA) class 2.
    ?Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study medication.
    ?Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    ?Uncontrolled hypertension. (systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
    ?Patients with phaeochromocytoma.
    ?Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
    ?Ongoing infection > grade 2 NCI-CTC version 3.0.
    ?Known history of human immunodeficiency virus (HIV) infection.
    ?Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiretroviral therapy.
    ?Patients with seizure disorder requiring medication.
    ?Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
    ?History of organ allograft
    ?Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event > CTCAE Grade 3 within 4 weeks of start of study medication.
    ?Non-healing wound, ulcer, or bone fracture.
    ?Renal failure requiring hemo-or peritoneal dialysis.
    ?Dehydration NCI-CTC version 3.0 grade > 1.
    ?Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results
    ?Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
    ?Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
    ?Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
    ?Patients unable to swallow oral medications
    ?Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample).
    ?Any malabsorption condition
    ?Unresolved toxicity higher than NCI-CTCAE (version 3.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia,oxaliplatin induced neurotoxicity and anti-EGFR Ab induced skin toxicity ? Grade 1
    ?Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site
    - Tratamiento anterior con regorafenib.
    - Interrupción del tratamiento de primera línea por progresión de la enfermedad o diagnóstico de progresión de la enfermedad previo a la entrada en el estudio.
    - Suposición de inhibidores fuertes del citocromo P (CYP) CYP3A4 (p. ej., claritromicina, indinavir, itraconazol, ketoconazol, nefazodona, nelfinavir, posaconazol, ritonavir, saquinavir, telitromicina, voriconazol) o inductores fuertes de CYP3A4 (p. ej., carbamazepina, fenobarbital, fenitoína, rifampicina, hierba de San Juan) (véase la sección 13.1).
    - Cáncer previo o concomitante que sea distinto en el lugar primario o histología de cáncer colorrectal en los 5 años previos a la aleatorización EXCEPTO por cáncer de cuello uterino tratado de forma curativa in situ, cáncer cutáneo no melanoma y tumores vesicales superficiales [Ta (tumor no invasivo), Tis (carcinoma in situ) y T1 (el tumor invade la lámina propia)].
    - Intervención quirúrgica mayor, biopsia abierta o lesión traumática importante en los 28 días previos al inicio del medicamento del estudio.
    - Pacientes que estén embarazadas o en periodo de lactancia. Las mujeres fértiles deben someterse a una prueba de embarazo un máximo de 7 días antes del inicio del tratamiento, y debe documentarse un resultado negativo antes del inicio del tratamiento.
    - Insuficiencia cardíaca congestiva de clase >= 2 de la Asociación del Corazón de Nueva York (New York Heart Association, NYHA).
    - Angina de pecho inestable (síntomas anginosos en reposo), angina de pecho de nuevo inicio (empezó en los 3 meses anteriores). Infarto de miocardio menos de 6 meses antes del inicio del medicamento del estudio.
    - Arritmias cardíacas que requieran tratamiento antiarrítmico (se permiten los
    betabloqueantes o la digoxina).
    - Hipertensión no controlada (presión arterial sistólica > 140 mm Hg o presión diabólica > 90 mm Hg a pesar del tratamiento médico óptimo).
    - Pacientes con feocromocitoma.
    - Episodios trombóticos o embólicos arteriales o venosos, como accidente cerebrovascular (incluidos accidentes isquémicos transitorios), trombosis venosa profunda o embolia pulmonar en los 6 meses previos al inicio del medicamento del estudio.
    - Infección en curso de grado > 2 NCI-CTC versión 3.0.
    - Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH).
    - Hepatitis B o C activa o hepatitis B o C crónica que requiere tratamiento con
    antirretrovirales.
    - Pacientes con trastorno convulsivo que requiere medicación.
    - Tumores cerebrales o meníngeos metastásicos sintomáticos, a menos que hayan transcurrido > 6 meses desde el tratamiento definitivo del paciente, se haya obtenido una prueba de imagen negativa en las 4 semanas previas a la entrada en el estudio y el paciente esté clínicamente estable en lo referente al tumor en el momento de la entrada en el estudio. Además, el paciente no debe estar recibiendo tratamiento agudo con esteroides o en disminución progresiva (el tratamiento crónico con esteroides es aceptable siempre que la dosis haya permanecido estable un mes antes y un mes después de las pruebas radiográficas de la selección).
    - Antecedentes de aloinjerto de órgano.
    - Pacientes con evidencia o antecedentes de diátesis hemorrágica. Cualquier hemorragia o episodio hemorrágico de grado 3 CTCAE en las 4 semanas previas al inicio del medicamento del estudio.
    - Herida sin cicatrizar, úlcera o fractura ósea.
    - Insuficiencia renal que requiere hemodiálisis o diálisis peritoneal.
    - Deshidratación de grado >= 1 NCI-CTC versión 3.0.
    - Toxicomanía, trastornos médicos, psicológicos o sociales que puedan interferir en la participación del paciente en el estudio o en la evaluación de los resultados del estudio.
    - Hipersensibilidad conocida a cualquiera de los fármacos del estudio, grupos de los fármacos del estudio o excipientes de la formulación.
    - Toda enfermedad o trastorno médico que sea inestable o pudiera poner en peligro la seguridad del paciente y su cumplimiento en el estudio.
    - Neumopatía intersticial con signos y síntomas en curso en el momento del
    consentimiento informado.
    - Pacientes que no pueden deglutir medicamentos orales.
    - Proteinuria persistente de grado 3 CTC o mayor (> 3,5 g/24 h, medidos por el cociente de proteína:creatinina en orina en una muestra de orina aleatoria).
    - Cualquier trastorno de mala absorción.
    - Relación estrecha con el centro de investigación; p. ej., familiar cercano del investigador o persona dependiente (p. ej., empleado o estudiante del centro de investigación).
    - Efecto adverso no resuelto de grado > 1 NCI-CTCAE (versión 3.0) atribuido a un
    tratamiento/procedimiento previo excluyendo alopecia, neurotoxicidad inducida por oxaliplatino y toxicidad cutánea inducida por anticuerpos anti-EGFR de grado <=1.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free Survival (PFS)
    Supervivencia sin Progresión (SSP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months
    9 meses
    E.5.2Secondary end point(s)
    Overall Survival
    Safety
    Supervivencia global
    Seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 months
    20 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 480
    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)
    The post-trial treatment of the patients is carried out according to the standard of care at the discretion of the attending physician.
    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 Decision2014-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-30
    P. End of Trial
    P.End of Trial StatusOngoing
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