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    Summary
    EudraCT Number:2014-003127-22
    Sponsor's Protocol Code Number:SOG-CPE-2014-03
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-11-04
    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 number2014-003127-22
    A.3Full title of the trial
    Phase II study with pazopanib and weekly paclitaxel in metastatic or locally advanced squamous penile carcinoma patients previously treated with cisplatin based chemotherapy
    Estudio fase II de tratamiento con pazopanib y paclitaxel en administración semanal en pacientes con carcinoma epidermoide de pene metastásico o localmente avanzado que hayan sido tratados previamente con esquemas de quimioterapia que incluyan platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with pazopanib and weekly paclitaxel in penile carcinoma
    Estudio de tratamiento con pazopanib y paclitaxel en administración semanal en pacientes con carcinoma de pene
    A.3.2Name or abbreviated title of the trial where available
    PAZOPEN
    PAZOPEN
    A.4.1Sponsor's protocol code numberSOG-CPE-2014-03
    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 SponsorSOGUG (Spanish Oncology Genitourinary Group)
    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 supportSOGUG
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES SOLUCIONES, S.L.
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressSalamanca, 7
    B.5.3.2Town/ cityTorrejón de la Calzada (MADRID)
    B.5.3.3Post code28991
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804103
    B.5.5Fax number+34918169172
    B.5.6E-mailjuanluis.sanz@apices.es
    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.2.5The 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 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 INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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.2.5The 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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: 3
    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.2.5The 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 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 INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Metastatic or locally advanced squamous penile carcinoma
    Carcinoma epidermoide de pene metastásico o localmente avanzado
    E.1.1.1Medical condition in easily understood language
    Penile cancer
    Cáncer de pene
    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 LLT
    E.1.2Classification code 10034318
    E.1.2Term Penile squamous cell carcinoma stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate response rate in terms of complete and partial response (RECIST criteria version 1.1)
    Evaluar la tasa de respuesta, en términos de respuesta completa y parcial, evaluada según los criterios RECIST versión 1.1
    E.2.2Secondary objectives of the trial
    - Clinical benefit rate (complete and partial response and stable disease) evaluated according RECIST criteria version 1.1
    - Progression free survival
    - Response duration
    - Overall survival
    - Safety and tolerability profile
    - Tasa de beneficio clínico (respuesta completa y parcial y enfermedad estable), evaluada según los criterios RECIST versión 1.1
    - Supervivencia libre de progresión
    - Duración de la respuesta
    - Supervivencia global
    - Perfil de seguridad y tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Age >= 18 years
    3. Histologically confirmed diagnosis of squamous cell carcinoma of the penis
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    5. Measurable disease criteria according to RECIST criteria (version 1.1)
    6. Progressive disease after treatment with cisplatin or carboplatin based chemotherapy. At least two cycles of chemotherapy had been administered either in neoadyuvant, adyuvant or metastatic setting.
    7. Archived tumor tissue must be provided for all subjects for biomarker analysis before and/or during treatment with investigational product.
    8. Adequate organ system function
    - Haemoglobin >= 9.0 gr/dl (5.6 mmol/L) and stable in the previous 4 weeks to start study treatment
    - Neutrophils >= 1.5 x 10*9/L
    - Platelets >= 100 x 10*9/L
    - Total bilirubin <= 1.5 x UNL
    - AST/SGOT and ALT/SGPT <= 2.5 x UNL
    9. Normal coagulation tests:
    - Prothrombin time (PT) or international normalized ratio (INR) <= 1.2 X ULN
    - Activated partial thromboplastin time (aPTT) <= 1.2 X ULN
    10. Are able to swallow and retain oral tablets
    1. Consentimiento informado por escrito
    2.Edad >= 18 años
    3. Diagnóstico histológico confirmado de carcinoma de pene de células escamosas
    4. ECOG PS 0-1
    5. Enfermedad medible según los criterios RECIST versión 1.1 (Anexo 4)
    6. Progresión de la enfermedad tras tratamiento con quimioterapia basada en cisplatino o carboplatino. Se deben haber administrado al menos dos ciclos de quimioterapia, ya sea en el ámbito neoadyuvante, adyuvante o metastásico
    7. Disponibilidad de tejido tumoral para el análisis de biomarcadores antes y/o durante la administración del tratamiento en investigación.
    8.Función hematológica, hepática y renal adecuadas:
    - Hemoglobina >= 9.0 gr/dl (5.6 mmol/L) y estable en las 4 semanas previas al inicio del tratamiento
    - Neutrófilos >= 1.5 x 10*9/L
    - Plaquetas >= 100 x 10*9/L
    - Bilirrubina total <= 1.5 x LSN
    - AST/SGOT y ALT/SGPT <= 2.5 x LSN
    - Creatinina <=1.5 x LSN (133 µmol/L). Si creatinina > 1.5 x LSN, el aclaramiento de creatinina deberá ser <= 30 mL/min calculado de acuerdo a la fórmula de Cockroft y Gault
    - Ratio Proteína/Creatinina < 1 o proteína en orina (de 24h) <1g
    9.Pruebas de coagulación normales:
    - Tiempo de protrombina (PT) o cociente normalizado internacional (INR) <= 1.2 X LSN
    - Tiempo parcial de tromboplastina activada <= 1.2 X LSN
    10. Capaz de tragar y retener los comprimidos orales
    E.4Principal exclusion criteria
    1. Prior malignancy.
    2. Central nervous system metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants
    3. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
    4. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
    5. Corrected QT interval (QTc) > 480 msecs
    6. History of any one or more of the following cardiovascular conditions within the past 6 months:
    - Cardiac angioplasty or stenting
    - Myocardial infarction
    - Unstable angina
    - Coronary artery bypass graft surgery
    - Symptomatic peripheral vascular disease
    - Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
    7. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >= 140 mmHg or diastolic blood pressure (DBP) of >= 90mmHg].
    8. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
    Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
    9. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
    10. Evidence of active bleeding or bleeding diathesis.
    11. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage
    12. Recent hemoptysis (>= 1/2 teaspoon [2.5 mL]) of red blood within 8 weeks before first dose of study drug).
    13. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subjects safety, provision of informed consent, or compliance to study procedures.
    14. Unable or unwilling to discontinue use of prohibited medications 14 days prior to the first dose of study drug and for the duration of the study.
    15. Treatment with any of the following anti-cancer therapies:
    - radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
    - chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days prior to the first dose of Pazopanib
    16. Administration of any non-oncologic investigational drug within 30 days prior to receiving the first dose of study treatment
    17. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
    18. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or paclitaxel and/or excipients that contraindicates their participation.
    19. Previous taxane or/and antiVEGF treatment would not allow patient to participate in the study.
    1. Enfermedad cancerosa previa.
    2. Metástasis en el sistema nervioso central (SNC) al inicio del estudio, a excepción de aquellos sujetos que hayan tenido metástasis en el SNC previamente tratadas (cirugía ± radioterapia, radiocirugía o bisturí de rayos gamma) y que cumplan los siguientes criterios: a. paciente asintomático y b. paciente que no precisa en la actualidad tratamiento con esteroides ni medicación anticonvulsivante inductores enzimáticos.
    3. Trastornos gastrointestinales clínicamente significativos que pueden aumentar el riesgo de sangrado gastrointestinal
    4. Trastornos gastrointestinales clínicamente significativos que puedan afectar a la absorción del producto en investigación
    5. Prolongación del intervalo QT corregido (QTc) > 480 milisegundos
    6. Historia de al menos uno de los siguientes trastornos cardiovasculares dentro de los últimos 6 meses:
    - Angioplastia o stent cardiaco
    - Infarto agudo de miocardio
    - Angina inestable
    - Cirugía coronaria de bypass
    - Enfermedad vascular periférica sintomática
    - Insuficiencia cardíaca congestiva de clase III o IV, definida por la New York Heart Association (NYHA)
    7. Hipertensión mal controlada [definida como presión arterial sistólica (PAS) >= 140 mmHg o presión arterial diastólica (PAD) >= 90 mmHg].
    8. Historia de accidente cerebrovascular incluido ataque isquémico transitorio (AIT), embolismo pulmonar o trombosis venosa profunda no tratada (TVP) en los últimos 6 meses.
    9. Cirugía mayor o traumatismo en los 28 días previos a la administración de la primera dosis del tratamiento del estudio y/o presencia de cualquier herida no cicatrizada, fractura o úlcera (procedimientos como la colocación de un catéter no se considera cirugía mayor).
    10. Evidencia de hemorragia activa o diátesis hemorrágica.
    11. Lesiones endobronquiales conocidas y/o lesiones que infiltran los vasos pulmonares mayores que aumentan el riesgo de hemorragia pulmonar.
    12. Hemoptisis reciente (>= 1/2 cucharadita o 2,5 mL) de sangre roja en las 8 semanas previas a la administración de la primera dosis del fármaco del estudio).
    13. Cualquier trastorno médico, psiquiátrico o de otro tipo que sea grave y/o inestable que pudiera interferir con la seguridad del paciente, la prestación del consentimiento informado, o el cumplimiento de los procedimientos del estudio.
    14. El paciente no puede o no quiere dejar de utilizar medicación no permitida en el estudio durante al menos 14 días antes de la primera dosis del fármaco del estudio y durante la duración del estudio.
    15. Tratamiento con cualquiera de las siguientes terapias contra el cáncer:
    - Radioterapia, cirugía o embolización del tumor dentro de los 14 días previos a la primera dosis de pazopanib
    - Quimioterapia, inmunoterapia, terapia biológica, fármacos en investigación o terapia hormonal dentro de los 14 días antes de la primera dosis de pazopanib
    16. Administración de cualquier fármaco en investigación no oncológico dentro de los 30 días previos a recibir la primera dosis del tratamiento del estudio.
    17. Presencia de cualquier toxicidad > Grado 1 y/o que está progresando en severidad relacionada con el tratamiento previo para el cáncer, excepto alopecia.
    18. Hipersensibilidad inmediata o tardía conocida a pazopanib o paclitaxel y/o fármacos químicamente relacionados con pazopanib o paclitaxel y/o a alguno de los excipientes, que contraindique su participación.
    19. Tratamiento previo con taxanos y/o antiVEGF.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate in terms of complete and partial response (RECIST criteria version 1.1)
    Tasa de respuesta, en términos de respuesta completa y parcial, evaluada según los criterios RECIST versión 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks
    Cada 8 semanas
    E.5.2Secondary end point(s)
    - Clinical benefit rate (complete and partial response and stable disease) evaluated according RECIST criteria version 1.1
    - Progression free survival
    - Response duration
    - Overall survival
    - Safety and tolerability profile
    - Tasa de beneficio clínico (respuesta completa y parcial y enfermedad estable), evaluada según los criterios RECIST versión 1.1
    - Supervivencia libre de progresión
    - Duración de la respuesta
    - Supervivencia global
    - Perfil de seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Every 8 weeks
    - Every 8 weeks
    - Every 8 weeks
    - Every 8 weeks
    - Every 4 weeks
    - Cada 8 semanas
    - Cada 8 semanas
    - Cada 8 semanas
    - Cada 8 semanas
    - Cada 4 semanas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety 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 Yes
    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.8.3 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 concerned8
    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
    LVLS
    Última visita del último paciente
    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 months6
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    F.2 Gender
    F.2.1Female No
    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 state32
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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