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    Summary
    EudraCT Number:2009-012616-40
    Sponsor's Protocol Code Number:CAMN107A2405
    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:2009-10-05
    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 number2009-012616-40
    A.3Full title of the trial
    ESTUDIO ABIERTO, ALEATORIZADO DE NILOTINIB VS. IMATINIB ESTÁNDAR (400/600 MG QD) COMPARANDO LA CINÉTICA DE LA RESPUESTA MOLECULAR COMPLETA EN PACIENTES CON LMC-FC CON EVIDENCIA DE LEUCEMIA PERSISTENTE POR RQ-RCP
    An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients with Evidence of Persistent Leukemia by RQ-PCR
    A.4.1Sponsor's protocol code numberCAMN107A2405
    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 Yes
    D.2.1.1.1Trade name TASIGNA 200 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical 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.3.8INN - Proposed INNNILOTINIB
    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 100 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/01/021
    D.3 Description of the IMP
    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
    D.3.9.3Other descriptive nameIMATINIB
    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 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
    Nilotinib vs. Imatinib Estándar (400/600 mg QD) Comparando la Cinética de la Respuesta Molecular Completa en Pacientes con LMC-FC con Evidencia de Leucemia Persistente por RQ-RCP.
    Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients with Evidence of Persistent Leukemia by RQ-PCR.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009012
    E.1.2Term Chronic myelogenous leukemia
    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 mejor tasa de RMC acumulada durante el primer año de terapia del estudio con nilotinib frente a imatinib
    -To compare the rate of confirmed best cumulative CMR within the first year of study therapy with nilotinib or imatinib
    E.2.2Secondary objectives of the trial
    - Caracterizar las cinéticas de la RMC conseguida en ambas ramas del tratamiento
    - Comparar la supervivencia libre de progresión entre las dos ramas
    - To characterize kinetics of CMR achieved in both treatment arms
    - To compare progression-free survival between the two arms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Pacientes = o >18 años de edad

    2-Diagnóstico de leucemia mieloide crónica en fase crónica (CML-CP) asociada con BCR- ABL cuantificable por medio de RQ-PCR (IS)

    3-CCyR* documentada por médula ósea (prueba citogenética estándar) o sangre periférica
    BCR-ABL <1% IS según se define en el apéndice 1

    4-Enfermedad persistente demostrada por dos pruebas positivas de PCR (es decir, nivel de BCR-ABL <1% IS) que se hayan realizado durante los últimos nueve meses y con una separación mínima entre sí de 10 semanas. Una de ellas debe realizarse en los 3 meses previos a la aleatorización (consulte la definición de enfermedad persistente en el apéndice 1).

    5-Tratamiento con imatinib durante al menos 2 años con 400 mg ó 600 mg y una dosis estable (la dosis no ha cambiado en los 6 meses anteriores). Los pacientes que recibieron 800 mg/día de imatinib en el pasado, pero cuya dosis se redujo posteriormente a 600 mg ó 400 mg/día durante más de 6 meses antes de la aleatorización también son elegibles para este estudio.

    6-Debe haber recibido tratamiento con Glivec®/Gleevec®

    7-Sin otra terapia contra la leucemia en la actualidad ni planificada

    8-Estado de funcionalidad ECOG 0,1 o 2

    9-Función de órgano terminal adecuada conforme a la definición:
    a. Bilirrubina total < 1,5 x LSN (LSN = límite superior dentro de lo normal en un laboratorio local institucional) No se aplica a los pacientes con hiperbilirubinemia (p. ej. enfermedad de Gilbert) grado <3.
    b. AST (SGOT) y ALT (SGPT) < 2,5 x LSN
    c. Amilasa sérica y lipasa = o < 1,5 x LSN
    d. Fosfatasa alcalina = or < 2,5 x LSN

    10-Los pacientes deben presentar los siguientes valores en los análisis de laboratorio (DLN = dentro de los límites normales en el laboratorio local institucional) o corregido dentro de los límites normales con suplementos antes de tomar la primera dosis de la medicación del estudio
    a. Potasio (DLN)
    b. Magnesio (DLN)
    c. Fosforo (DLN)
    d. Calcio (DLN)

    11. Esperanza de vida superior a 12 meses sin necesidad de realizar ninguna intervención

    12. El paciente ha otorgado el consentimiento informado por escrito para participar en este estudio

    *Nota: Una de las pruebas PCR empleadas para documentar la persistencia de la enfermedad también puede servir para documentar la CCyR, si <1% en la IS (véase el criterio de inclusión n. 4)
    E.4Principal exclusion criteria
    1. Fase acelerada o crisis blástica previas
    2. El paciente tiene evidencia de un incremento de PCR (un incremento confirmado >1 log en los 6 meses anteriores)

    3. El paciente ha recibido otro agente en investigación en los últimos 6 meses o TKI diferente de imatinib

    4. Trasplante previo de células madre

    5. Alteración de la función cardíaca que incluya cualquiera de las siguientes:
    a.Incapacidad para controlar el intervalo QT/QTc en el ECG
    b.Síndrome del QT largo o antecedentes familiares conocidos de síndrome de QT largo.
    c.Bradicardia en reposo clínicamente significativa (< 50 latidos por minuto)
    d.QTc > 450 ms en ECG inicial de referencia (mediante la fórmula QTcF). QTcF >450 ms y los electrolitos no están dentro del intervalo normal, es necesario corregir los electrolitos y, entonces, volver a seleccionar para QTc
    e.Infarto de miocardio en los 12 meses anteriores al inicio del estudio
    f.Otras enfermedades cardíacas sin controlar clínicamente significativas (p. ej. angina inestable, insuficiencia cardíaca congestiva o hipertensión sin controlar)
    g.Antecedentes o presencia de taquiarritmias auriculares o ventriculares

    6. Administración de terapia con citoquina (p. ej. G-CSF, GM-CSF o SCF) en las 4 semanas anteriores al comienzo del estudio

    7. Transcripción atípica de BCR-ABL no cuantificable mediante RQ-PCR estándar.

    8. Otra enfermedad maligna importante, que requiere tratamiento general (quimioterapia o radiación)

    9. Enfermedad hepática aguda

    10. Enfermedad pancreática aguda o grave

    11. Otra enfermedad grave o que ponga en riesgo la vida

    12. Antecedentes de trastorno hemorrágico adquirido o congénito importante no relacionado con el cáncer

    13. Alteración de la función gastrointestinal (GI) o enfermedad GI que pueda alterar significativamente la absorción del fármaco del estudio

    14. Pacientes que reciban activamente terapia con inhibidores potentes de CYP3A4 y el tratamiento no se puede ni retirar ni transferir a otro medicamento antes de comenzar con el fármaco del estudio

    15. Pacientes que están recibiendo tratamiento con cualquier medicación que tenga la posibilidad de prolongar el intervalo QT y el tratamiento no se puede ni retirar ni transferir a otro medicamento antes de comenzar con el fármaco en estudio

    16. Los pacientes que estén: (a) embarazadas, (b) en periodo de lactancia, (c) o que puedan concebir sin una prueba de embarazo negativa antes del momento inicial y (d) los hombres o mujeres con capacidad para concebir que no deseen usar medidas anticonceptivas durante el ensayo (las mujeres posmenopáusicas deben estar amenorreicas durante al menos 12 meses para que se considere que carecen de capacidad para concebir)

    17. Interrupción de la terapia con imatinib durante un periodo acumulado que supere los 21 días en los 3 meses anteriores

    18. Toxicidad importante de imatinib en los últimos 3 meses

    19. Antecedentes de incumplimiento o incapacidad para otorgar el consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de RMC acumulada durante el primer año de terapia del estudio con nilotinib frente a imatinib
    Rate of confirmed best cumulative CMR within the first year of study therapy with nilotinib or imatinib
    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 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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 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
    último paciente última visita
    last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 192
    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 Decision2009-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-03
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