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    Summary
    EudraCT Number:2007-000208-34
    Sponsor's Protocol Code Number:CAMN107A2303
    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:2007-04-02
    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 number2007-000208-34
    A.3Full title of the trial
    Estudio fase III, multicéntrico, abierto, aleatorizado de imatinib frente a nilotinib, en pacientes adultos con leucemia mieloide crónica cromosoma Filadelfia positivo (Ph+) en fase crónica (LMC-FC) de nuevo diagnóstico
    A.4.1Sponsor's protocol code numberCAMN107A2303
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/06/375
    D.3 Description of the IMP
    D.3.1Product namenilotinib
    D.3.2Product code AMN107
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMN107
    D.3.9.3Other descriptive namenilotinib
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/1/01/198/
    D.3 Description of the IMP
    D.3.1Product nameimatinib
    D.3.2Product code STI571
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNImatinib mesilate
    D.3.9.1CAS number 220127-57-1
    D.3.9.2Current sponsor codeSTI571
    D.3.9.3Other descriptive nameGlivec
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.IMP: 3
    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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/1/01/198/
    D.3 Description of the IMP
    D.3.1Product nameimatinib
    D.3.2Product code STI571
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNImatinib mesilate
    D.3.9.1CAS number 220127-57-1
    D.3.9.2Current sponsor codeSTI571
    D.3.9.3Other descriptive nameGlivec
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.IMP: 4
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/06/375
    D.3 Description of the IMP
    D.3.1Product namenilotinib
    D.3.2Product code AMN107
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMN107
    D.3.9.3Other descriptive namenilotinib
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    La población del estudio incluye pacientes adultos con nuevo diagnóstico citológico confirmado de LMC-FC Ph+.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Comparar la eficacia (tasa de MMR RMM a los 12 meses) de 400 mg BID de nilotinib con la de 400 mg QD de Glivec en pacientes con LMC-FC cromosoma Filadelfia positivo (Ph+) de nuevo diagnóstico y no tratada previamente.
    • Comparar la eficacia (tasa de MMR RMM a los 12 meses) de 600 mg QD de nilotinib con la de 400 mg QD de Glivec en pacientes con LMC-FC cromosoma Filadelfia positivo (Ph+) de nuevo diagnóstico y no tratada previamente.
    E.2.2Secondary objectives of the trial
    • Evaluar la tasa de RMM a los 12 meses, entre los dos grupos de nilotinib.
    • Evaluar el tiempo hasta y la duración de la RMM de los grupos de tratamiento con nilotinib comparado con Glivec, en pacientes adultos con LMC-FC Ph+.
    • Evaluar el tiempo hasta y la duración de una reducción superior o igual a 4 logaritmos de los niveles de transcritos BCR-ABL, respecto al basal estandarizado de los grupos de tratamiento con nilotinib comparado con Glivec, en pacientes adultos con LMC-FC Ph+.
    • Evaluar la tasa de una reducción superior o igual a 4 logaritmos de los niveles de transcritos BCR-ABL,de los grupos de tratamiento con nilotinib comparado con Glivec, en pacientes adultos con LMC-FC Ph+ después de los 12 meses.
    • Evaluar el perfil de seguridad de los grupos de tratamiento con nilotinib y con Glivec, en pacientes adultos con LMC-FC Ph+.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-estudio opcional de biomarcadores exploratorios. Basado en el protcolo original con fecha 5/2/07
    •• Evaluar los resultados notificados por el paciente (PRO) incluyendo la calidad de vida (QoL), periodo de tiempo de inhabilidad y hospitalizaciones en los tres grupos de tratamiento.
    • Investigar la presencia de mutaciones del BCR-ABL observadas recientemente en los pacientes después de la visita basal y correlacionarlas con al respuesta al tratamiento con imatinib y nilotinib.
    • Examinar si la variación genética individual en los genes relacionados con el metabolismo farmacológico, la patogénesis de la LMC y la trayectoria del fármaco de referencia confieren distintas respuestas a nilotinib y a imatinib (evaluación farmacogenética).
    • Identificar perfiles de expresión genética o marcadores individuales cuya expresión esté asociada con la respuesta al tratamiento con nilotinib y/o imatinib y que posiblemente correlacionen con la severidad y progresión de la enfermedad (evaluación farmacogenómica).
    • Identificar fuentes de variabilidad de la PK de imatinib y de nilotinib además de investigar las relaciones PK/PD de nilotinib y de imatinib.
    • Evaluar 600 mg QD y/o 400 mg BID de nilotinib frente a 400 mg BID de imatinib, combinando los resultados de los estudios AMN107A2302 y STI571K2301.
    • Evaluar el efecto de nilotinib en el estado diabético de pacientes con un diagnóstico conocido y desconocido de diabetes Tipo II concomitante
    E.3Principal inclusion criteria
    •• Pacientes hombres o mujeres con ≥ 18 años.
    • ECOG 0, 1 ó 2.
    • Pacientes que se encuentren dentro de los 6 meses del diagnóstico de LMC-FC (la fecha del diagnóstico inicial es la fecha del primer análisis citogenético). Deberán realizarse análisis citogenéticos convencionales estándares de la médula ósea.(No se aceptará el análisis FISH).
    • Diagnóstico de leucemia mieloide crónica en fase crónica con confirmación citogenética de cromosoma Filadelfia de translocaciones (9;22) (con presencia de BCR-ABL deberán examinarse un mínimo de 20 metafases).
    • LMC en fase crónica documentada cumplirá todos los criterios definidos con:
    • < 15% de blastos en sangre periférica y médula ósea
    • < 30% de blastos más promielocitos en sangre periférica y médula ósea
    • < 20% de basófilos en sangre periférica
    • ≥ 100 x 109/L (≥ 100,000 /mm3) de plaquetas
    • Sin evidencia de lesión leucémica extramedular, con la excepción de hepatoesplenomegalia.
    • Función orgánica final adecuada, definida con:
    • Bilirrubina total < 1.5 x ULN
    • SGOT y SGPT < 2.5 x UNL
    • creatinina < 1.5 x ULN
    • Amilasa y lipasa sérica ≤ 1.5 x ULN
    • Fosfatasa alcalina ≤ 2.5 x ULN, a menos que se considere que es debido al tumor
    • Las pacientes físicamente fértiles deberán presentar una prueba de embarazo negativa en suero durante los 7 días previos al inicio de la medicación del estudio.
    • Los pacientes deben presentar los siguientes valores de laboratorio (≥ LLN (límite inferior de normalidad) o corregible hasta dentro de los límites de normalidad con suplementos antes de la primera dosis de la medicación del estudio):
    • Potasio ≥ LLN
    • Magnesio ≥ LLN
    • Fósforo ≥ LLN
    • Capacidad para proporcionar el consentimiento informado por escrito antes de iniciar cualquier procedimiento de selección relacionado con el estudio.
    E.4Principal exclusion criteria
    • • Mutaciones T315I previamente documentadas.
    • No está permitido el tratamiento con inhibidor(es) de la tirosina quinasa antes de iniciar el estudio, excepto en la siguiente situación: en casos urgentes en los que el paciente precise control de la enfermedad mientras espera que se inicie el estudio, se le puede prescribir Glivec comercializado a cualquier dosis, pero no durante más de 2 semanas.
    • Cualquier tratamiento médico para la LMC antes de iniciar el estudio durante más de 2 semanas, con la excepción de hidroxiurea y/o anagrelida.
    • Deterioro de la función cardíaca, que incluya alguno de los siguientes acontecimientos:
    • LVEF < 45% o por debajo del límite inferior de normalidad del centro (el que sea mayor), determinada con ecocardiograma
    • Incapacidad para determinar el intervalo QT en el EGC
    • Bloqueo completo de rama izquierda
    • Uso de un marcapasos cardíaco
    • Síndrome congénito de intervalo QT prolongado o antecedentes familiares de síndrome de QT prolongado
    • Antecedentes o presencia de taquiarritmias auriculares o ventriculares clínicamente significativas
    • Bradicardia en reposo clínicamente significativa (< 50 pulsaciones por minuto)
    • QTc > 450 mseg en el ECG de la visita basal (utilizando la fórmula QTcF). Si el QTcF > 450 mseg y los electrolitos no se encuentran dentro de los límites de normalidad, deberían corregirse los electrolitos y entonces al paciente se le volverá a analizar el QTc
    • Infarto de miocardio durante los 12 meses previos al inicio estudio
    • Otras enfermedades cardíacas clínicamente significativas (por ejemplo, angina inestable, insuficiencia cardíaca congestiva o hipertensión incontrolada)
    • Infiltración citopatológicamente confirmada conocida del SNC (en ausencia de sospecha afectación del SNC, no es preciso realizar la punción lumbar)
    • Condiciones médicas incontroladas o severas (por ejemplo, diabetes incontrolada, infección incontrolada o activa).
    • Antecedentes de trastornos hemorrágicos adquiridos o congénitos significativos no relacionados con el cáncer.
    • Radioterapia previa en ≥ 25% de la médula ósea.
    • Pacientes que hayan sido sometidos a cirugía mayor durante las 4 semanas previas al Día 1 del estudio o que no se hayan recuperado de la cirugía previa.
    • Tratamiento con otros fármacos en investigación durante los 30 días previos al Día 1.
    • Pacientes con antecedentes de incumplimiento de regímenes médicos o con incapacidad para otorgar un consentimiento informado fiable.
    • Uso de derivados cumarínicos terapéuticos (es decir, warfarina, acenocumarol, fenprocumon).
    • Pacientes con otra enfermedad maligna principal, excepto en el caso de que la otra enfermedad maligna principal no sea clínicamente significativa actualmente ni precise intervención activa.
    • Pacientes que tomen cualquier dosis de los siguientes inhibidores potentes del CYP3A4: eritromicina, ketoconazol, itraconazol, voriconazol, claritromicina, telitromicina, ritonavir, mibefradil) y que el tratamiento no pueda suspenderse ni cambiarse por otra medicación distinta antes de iniciar la medicación del estudio. La lista completa de estas medicaciones se encuentra en la página web http://medicine.iupui.edu/flockhart/table.htm. Deberá contactarse con Novartis, si un paciente precisa iniciar el tratamiento con alguno de estos fármacos durante el estudio.
    • Deterioro de la función gastrointestinal (GI) o enfermedad GI que pueda alterar significativamente la absorción de la medicación del estudio (por ejemplo, enfermedades ulcerativas, náuseas incontroladas, vómitos, diarrea, síndrome de malabsorción, resección del intestino delgado o cirugía de bypass gástrico).
    • Pacientes con antecedentes de pancreatitis aguda durante el año previo al inicio del estudio o antecedentes médicos previos de pancreatitis crónica.
    • Pacientes con enfermedad renal severa o pancreática, hepática crónica o aguda que se considere no relacionada con el tumor.
    • Pacientes que estén recibiendo actualmente tratamiento con alguna de las medicaciones con potencial para prolongar el intervalo QT y que el tratamiento no pueda ni suspenderse ni cambiarse a una medicación diferente antes de iniciar la medicación del estudio. (Por favor, véase http://torsades.org/medical-pros/drug-lists/printable-drug-list.cfm, para una lista global de los fármacos que prolongan el intervalo QT).
    • Pacientes: (a) embarazadas, (b) lactantes, (c) físicamente fértiles sin una prueba de embarazo negativa antes de la visita basal y (d) hombres o mujeres físicamente fértiles que no deseen utilizar métodos anticonceptivos durante todo el ensayo (las mujeres postmenopáusicas deberán haber permanecido amenorréicas durante por lo menos 12 meses para ser consideradas físicamente no fértiles)
    E.5 End points
    E.5.1Primary end point(s)
    La variable de eficacia principal es la tasa de respuesta molecular mayor (RMM) a los 12 meses después del inicio de la primera medicación del estudio, medida con una reducción de  3 logaritmos del transcrito BCR-ABL, respecto a un basal estandarizado o con el % del gen de control/BCR-ABL ≤ 0.1% con la escala internacional, medida con.RT-PCR-Q.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA226
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Los pacientes pueden continuar el tratamiento en el protocolo durante hasta 5 años, hasta la progresión o hasta que al paciente ya no le resulte beneficioso continuar con el tratamiento del estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 318
    F.4.2.2In the whole clinical trial 771
    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 Decision2007-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-21
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