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    Summary
    EudraCT Number:2013-004714-18
    Sponsor's Protocol Code Number:INCB18424-267
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-16
    Trial results View 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 number2013-004714-18
    A.3Full title of the trial
    A Randomized, Double-Blind Study of Ruxolitinib or Placebo in
    Combination With Regorafenib in Subjects With Relapsed or
    Refractory Metastatic Colorectal Cancer
    Estudio con enmascaramiento doble y aleatorizado, de Ruxolitinib o placebo en combinación con Regorafenib en pacientes con cáncer colorrectal metastásico recidivante o resistente al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ruxolitinib in Combination With Regorafenib in Subjects Metastatic Colorectal Cancer
    Estudio de Ruxolitinib combinado con Regorafenib en pacientes con Cancer Colorectal Metastasico
    A.3.2Name or abbreviated title of the trial where available
    Ruxolitinib in Combination With Regorafenib in Metastatic Colorectal Cancer
    A.4.1Sponsor's protocol code numberINCB18424-267
    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 SponsorIncyte Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressRt 141 &Henry Clay Road
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19880
    B.5.3.4CountryUnited States
    B.5.5Fax number13024252734
    B.5.6E-mailRegAffairs@incyte.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 Jakafi
    D.2.1.1.2Name of the Marketing Authorisation holderIncyte Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameruxolitinib
    D.3.2Product code INCB018424
    D.3.4Pharmaceutical form 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 INNruxolitinib
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeINCB018424
    D.3.9.3Other descriptive nameRUXOLITINIB
    D.3.9.4EV Substance CodeSUB32273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Pharma AG
    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 nameRegorafenib
    D.3.2Product code L01XE21
    D.3.4Pharmaceutical form 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 number40
    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 placeboTablet
    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
    Relapsed or refractory metastatic colorectal cancer
    CCR metastásico recidivante o resistente al tratamiento.
    E.1.1.1Medical condition in easily understood language
    Advanced colorectal cancer
    Cancer Colorectal avanzado.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10010030
    E.1.2Term Colorectal cancer recurrent
    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 17.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term 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
    Part 1 (Safety Run-in)
    - To determine the doses of ruxolitinib and regorafenib that are safe and tolerable when administered in combination.
    Part 2 (Randomized Phase)
    - To evaluate and compare the OS of subjects with metastatic CRC when treated with ruxolitinib in combination with regorafenib versus regorafenib alone.
    Parte 1 (fase de preinclusión de seguridad):
    - Determinar las dosis de ruxolitinib y regorafenib que son seguras y tolerables cuando se administran en combinación.

    Parte 2 (fase aleatorizada):
    - Evaluar y comparar la supervivencia global (SG) de sujetos con CCR metastásico cuando reciben tratamiento con ruxolitinib en combinación con regorafenib comparado con regorafenib en solitario.
    E.2.2Secondary objectives of the trial
    - To evaluate and compare the efficacy of the 2 treatment groups with respect to PFS.
    -To evaluate and compare the efficacy of the 2 treatment groups with respect to overall tumor response and duration of response.
    -To evaluate and compare disease control of ruxolitinib in combination with regorafenib versus regorafenib alone.
    -To evaluate and compare the safety and tolerability of ruxolitinib in combination with regorafenib versus regorafenib alone.
    - Evaluar y comparar la eficacia de los dos grupos de tratamiento con respecto a la supervivencia sin progresión

    - Evaluar y comparar la eficacia de los dos grupos de tratamiento con respecto a la respuesta tumoral global y la duración de la respuesta.

    - Evaluar y comparar el control de la enfermedad de ruxolitinib en combinación con regorafenib y de regorafenib en solitario.

    - Evaluar y comparar la seguridad y la tolerabilidad de ruxolitinib en combinación con regorafenib y de regorafenib en solitario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female 18 years or older.
    - Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic.
    - Previous treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti-VEGF therapy (if no contraindication); and if KRAS wild type and no contraindication, an anti-EGFR therapy; and progressed following the last administration of approved therapy.
    - Radiographically measurable or evaluable disease (per RECIST 1.1).
    - Eastern Cooperative Oncology Group performance status of 0 to 2.
    - Three or more weeks have elapsed from the completion of previous treatment regimen and subjects must have recovered or be at a new stable baseline from any related toxicities.
    - Radiotherapy to disease sites is allowed provided:
    - Four or more weeks have elapsed since the completion of radiation therapy.
    - Subjects who received palliative radiation treatment to a limited field or on an accelerated schedule within the last 7 days are eligible
    - Disease sites within the field of prior irradiation have subsequently progressed or there are other metastatic disease sites outside the field of prior irradiation.
    - All treatment related toxicities have resolved or are at a new stable baseline.
    - Hombres o mujeres de 18 años o más.
    - Adenocarcinoma de colon o recto metastásico confirmado mediante histología o citología.
    - Tratamiento previo con quimioterapia con fluoropirimidina, oxaliplatino e irinotecán; un tratamiento anti VEGF (factor de crecimiento endotelial vascular) (si no hay contraindicación); y si el gen KRAS es de tipo natural y no hay contraindicación, un tratamiento anti EGFR (receptor del factor de crecimiento epidérmico); y progresión tumoral tras la última administración del tratamiento aprobado.
    - También podrán participar en el estudio los sujetos que han suspendido el tratamiento por toxicidad inaceptable.
    - Enfermedad medible o evaluable radiográficamente (según RECIST 1.1).
    - Estado funcional de 0 a 2 segú el Grupo Oncolóico Cooperativo de la Costa Este.
    - Han transcurrido al menos tres semanas desde la finalización del régimen de tratamiento anterior y los sujetos deben haberse recuperado o estar en un nuevo punto inicial estable de cualesquiera toxicidades relacionadas con el tratamiento.
    - Se permite la radioterapia en las localizaciones tumorales, siempre que:
    - Hayan transcurrido al menos cuatro semanas desde la finalización de la radioterapia.
    - Los sujetos que recibieron radioterapia paliativa en un campo limitado o con una pauta acelerada en los últimos 7 días son elegibles para la inclusión.
    - Las localizaciones tumorales situadas dentro del campo de irradiación anterior han progresado posteriormente o hay otras localizaciones tumorales metastásicas fuera del campo de irradiación anterior.
    -Todas las toxicidades relacionadas con el tratamiento se han resuelto o han alcanzado un nuevo punto inicial estable
    E.4Principal exclusion criteria
    Subjects who meet any of the following will not be included in the study:
    - Received prior treatment with regorafenib.
    - Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
    - History of abdominal fistula or gastrointestinal perforation at any point within 6 months prior to day 1 of study drug administration, unless surgically repaired.
    Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.
    - Recent history (?4 weeks of Day 1 of study drug administration) of a major surgery or significant traumatic injury.
    - Recent history (? 3 months) or ongoing partial or complete bowel obstruction unless corrected with surgery.
    - Blood pressure ? 140/90 mmHg
    - Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
    - Known central nervous system metastases or history of uncontrolled seizures.
    - Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class II, III, or IV congestive heart failure, and arrhythmia requiring therapy.
    - Creatinine clearance < 50 mL/min measured or calculated by Cockroft-Gault equation
    - Inadequate hepatic, and bone marrow function as evidenced by:
    - Absolute neutrophil count < 1.5 × 109/L.
    - Platelets < 100 × 109/L.
    - Hemoglobin < 9 g/dL (transfusions are permitted to achieve baseline hemoglobin level).
    - ALT/AST > 2.5 × the upper limit of normal (ULN); or > 5 × ULN in the presence of liver metastases.
    - Total bilirubin > 1.5 × ULN (if total bilirubin is > 1.5 × ULN then the subject may participate if the direct bilirubin is ? 1.5 × ULN).
    - Concurrent anticancer therapy
    - Subjects who participated in any other study in which an investigational study drug was received within 28 days prior to first dose.
    - Current or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
    - Known HIV infection.
    - HBV or HCV viremia or at risk for HBV or HCV reactivation.
    sujetos que cumplan alguno de los siguientes criterios:
    - Han recibido tratamiento previo con regorafenib.
    - Presencia de enfermedad digestiva activa u otra afección que interferiría significativamente con la absorción de fármacos.
    - Antecedentes de fístula abdominal o perforación gastrointestinal en cualquier punto en los 6 meses anteriores al día 1 de administración del fármaco del estudio, salvo que se haya reparado quirúrgicamente.
    - Úlcera péptica activa, enteropatía inflamatoria (como colitis ulcerosa, enfermedad de Crohn), diverticulitis u otra afección digestiva con aumento del riesgo de perforación o hemorragia digestiva.
    - Antecedentes recientes (<= 4 semanas antes del día 1 de administración del fármaco del estudio) de una cirugía mayor o lesión traumática significativa.
    - Antecedentes recientes <= 3 meses) de obstrucción intestinal completa o parcial en curso, salvo que se haya corregido mediante cirugía.
    - Tensión arterial >=140/90 mmHg.
    - Enfermedad infecciosa crónica o actual activa que requiera tratamiento con antimicóticos, antivíricos o antibióticos sistémicos.
    - Metástasis conocidas en el sistema nervioso central o antecedentes de convulsiones no controladas.
    - Cardiopatía significativa desde el punto de vista clínico incluidos angina inestable, infarto agudo de miocardio en los 6 meses anteriores al día 1 de administración del fármaco del estudio, insuficiencia cardiaca congestiva de clase II, III o IV de la New York Heart Association y arritmia que requiere tratamiento.
    - Aclaramiento de creatinina <50 ml/min medido o calculado mediante la ecuación de Cockroft-Gault o tasa de filtración glomerular (TFG) estimada <50 ml/min/1,73 m2 usando la fórmula MDNP.
    - Función hepática y medular inadecuada, puesta de manifiesto por:
    - Cifra absoluta de neutrófilos <1,5 × 109/l.
    - Trombocitos <100 × 109/l.
    - Hemoglobina <9 g/dl (se permiten las transfusiones para alcanzar el nivel de hemoglobina basal).
    - ALAT/ASAT >2,5 × límite superior de la normalidad (LSN), o >5 × LSN en presencia de metástasis hepáticas.
    - Bilirrubina total >1,5 × LSN (si la bilirrubina total es >1,5 × LSN el sujeto puede participar si la bilirrubina directa es ?,5 × LSN).
    - Tratamiento antineoplásico concurrente (p. ej., quimioterapia, radioterapia, cirugía, inmunoterapia, terapia biológica, terapia hormonal o embolización del tumor).
    -Sujetos que participaron en cualquier otro estudio en el que se recibió un fármaco en investigación en los 28 días anteriores a la primera dosis.
    - Otra neoplasia maligna actual o previa en los 5 años anteriores a la entrada en el estudio, salvo carcinoma cutáneo espinocelular o basocelular curado, carcinoma vesical superficial, neoplasia intraepitelial de próstata, carcinoma localizado de cuello uterino u otra neoplasia maligna no invasiva
    - Infecció por VIH conocida.
    - Viremia por VHB o VHC o riesgo de reactivación del VHB o VHC.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint OS is defined as the interval from date of randomization to death due to any cause.
    El criterio principal de Supervivencia global determinada desde la fecha de la aleatorización hasta la muerte por cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint OS is defined as the interval from date of randomization to death due to any cause. Subjects without death observed at the time of the analysis will be censored at last date known to be alive.
    El criterio principal de valoración de la SG se define como el intervalo desde la fecha de la aleatorización hasta la muerte por cualquier causa. Los pacientes cuya muerte no se haya constatado en el momento del análisis se censurarán en la última fecha en que se sabe que estaban vivos.
    E.5.2Secondary end point(s)
    PFS, defined as the interval from date of randomization to the earlier of death or disease progression by RECIST 1.1 as assessed by the investigator.

    ORR by treatment groups along with 95% exact CIs.
    La SSP, definida como el intervalo desde la fecha de la aleatorización hasta la muerte o la progresión de la enfermedad según RECIST 1.1, lo que ocurra antes, según evaluación del investigador.

    La TRG se presentará por grupos de tratamiento junto con los IC exactos del 95 %.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The interval from date of randomization to the earlier of death or disease progression by RECIST 1.1 as assessed by the investigator
    El intervalo desde la fecha de la aleatorización hasta la muerte o la progresión de la enfermedad según RECIST 1.1, lo que ocurra antes, según evaluación del investigador.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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) 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 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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Spain
    United Kingdom
    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
    There is no predefined end of trial
    No está predefinido el fin de ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    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 months5
    E.8.9.2In all countries concerned by the trial days1
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 210
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 420
    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
    N/A
    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 Decision2014-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-17
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