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    Summary
    EudraCT Number:2009-017775-19
    Sponsor's Protocol Code Number:CAMN107EIC01
    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:2010-03-22
    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 number2009-017775-19
    A.3Full title of the trial
    Estudio fase IIIb, multicéntrico, abierto, de nilotinib, en pacientes adultos con LMC Ph+ de nuevo diagnóstico en fase crónica y /o BCR-ABL positivo

    A Phase IIIb, multicentre, open-label study of nilotinib in adult patients with newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase
    A.3.2Name or abbreviated title of the trial where available
    ENEST1st
    A.4.1Sponsor's protocol code numberCAMN107EIC01
    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.3.8INN - Proposed INNnilotinib
    D.3.9.1CAS number 923288-90-8
    D.3.9.2Current sponsor codeAMN107
    D.3.9.3Other descriptive nameNILOTINIB HYDROCHLORIDE MONOHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Pacientes adultos con LMC Ph+ de nuevo diagnóstico en fase crónica y /o BCR-ABL positivo

    Newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase in adult patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10052065
    E.1.2Term Chronic phase chronic myeloid leukaemia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objetivo principal:
    • Evaluar la tasa de RMC después de 18 meses de tratamiento con nilotinib.

    To evaluate the rate of CMR after 18 months of nilotinib treatment
    E.2.2Secondary objectives of the trial
    Objetivos secundarios:
    • Evaluar la tasa de progresión anual y de eventos anuales a los 12 y 24 meses de tratamiento.
    • Evaluar la tasa de respuesta molecular mayor a los 12 y 24 meses de tratamiento
    • Evaluar la tasa de respuesta citogenética completa a los 12 y 24 meses de tratamiento
    • Evaluar la tasa de RMC a los 12 y 24 meses de tratamiento
    • Evaluar la tasa anual de eventos en pacientes que alcancen una RMC a los 12 meses de tratamiento.
    • Evaluar la supervivencia libre de evento (SLE) y la supervivencia global (SG) a los 12 meses de tratamiento y a los 24 meses de tratamiento
    • Evaluar el perfil de seguridad y de tolerabilidad de nilotinib
    Objetivos exploratorios:
    • Identificar la dinámica de la respuesta molecular y los patrones potenciales.
    • Evaluar la cinética de la RMM a los 3, 6, 9, 12, 15, 18, 21 y 24 meses de tratamiento


    To evaluate the rate of annual progression and annual events at 12 and 24 months of treatment
    To evaluate the rate of major molecular
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes deberán cumplir todos los criterios de inclusión y ninguno de los criterios de exclusión para poder participar en el estudio. Los pacientes deberán cumplir todos los criterios de inclusión dentro de las 4 semanas previas a la inclusión (las evaluaciones de la médula ósea pueden realizarse dentro de las 8 semanas previas) para participar en el estudio.
    Criterios de inclusión:
    • Mujeres o varones con diagnóstico de LMC-FC con confirmación citogenética de cromosoma Ph [translocación t(9;22)] (si la muestra de médula ósea se obtuvo durante las 8 semanas previas al inicio del estudio pero antes de que el paciente otorgase su consentimiento, la muestra de médula ósea no debería repetirse después de que el paciente consienta formalmente a participar en el estudio).
    • Los casos de Ph negativo o los pacientes con translocaciones variantes que sean BCR-ABL positivos en PCR multiplex (Cross et al 1994) también son elegibles.
    • El pretratamiento con hidroxiurea durante hasta 6 meses está permitido igual que el tratamiento con imatinib durante hasta 3 meses. El investigador deberá informar al CMD solicitando la revisión de cualquier paciente que haya recibido tratamiento previo con imatinib durante 6 semanas o más para asegurar que el paciente no esté presentando fallo al tratamiento con imatinib.
    • Edad &#8805; 18 años (ningún límite superior de edad)
    • Estado funcional de la OMS 0-2
    • Niveles séricos normales &#8805; LIN (límite inferior de normalidad) de potasio, magnesio, calcio total corregido para la albúmina sérica o fósforo o corregido hasta dentro de los límites de normalidad con suplementos, antes de la primera dosis de la medicación del estudio.
    • AST y ALT &#8804; 2.5 x LSN o &#8804; 5.0 x LSN, si se considera debido a la leucemia
    • Fosfatasa alcalina &#8804; 2.5 x LSN, a menos que se considere debido a la leucemia
    • Bilirrubina total &#8804; 1.5 x LSN, excepto Síndrome de Gilbert conocido
    • Amilasa y lipasa sérica &#8804; 1.5 x LSN
    • Creatinina sérica &#8804; 1.5 x LSN
    • Consentimiento informado por escrito antes de realizar cualquier procedimiento del estudio



    Patients must meet all inclusion criteria and none of the exclusion criteria to enter the study. Patients must meet all inclusion criteria within 4 weeks of enrollment (bone marrow examinations may be within 8 weeks) to enter the study.
    ? Male or female patients with diagnosis of CP-CML with
    cytogenetic confirmation of Ph chromosome [t(9;22)
    translocation] (if the bone marrow sample is taken within 8 weeks
    of study start but before the patient consents, the bone marrow
    should not be repeated after the patient formally consents to the
    study)
    ? Ph negative cases or patients with variant translocations who are
    BCR-ABL positive in multiplex PCR (Cross et al 1994) are eligible
    as well
    ? Pretreatment with Hydroxyurea for a duration of up to 6 months is
    permitted as is treatment with Imatinib for up to 3 months The
    investigator should notify the DMC requesting review of any
    patient who has received prior imatinib treatment for 6 or more
    weeks to ensure that the patient is not failing on imatinib.
    ? Age ? 18 years old (no upper age limit)
    ? WHO performance status 0-2
    ? Normal serum levels ? LLN (lower limit of normal) of potassium,
    magnesium, total calcium corrected for serum albumin or
    phosphorus, or corrected to within normal limits with
    supplements, prior to the first dose of study medication
    ? AST and ALT ? 2.5 x ULN or ? 5.0 x ULN if considered due to
    leukaemia
    ? Alkaline phosphatase ? 2.5 x ULN unless considered due to
    leukaemia
    ? Total bilirubin ? 1.5 x ULN, except know Mb. Gilbert
    ? Serum lipase and amylase ? 1.5 x ULN
    ? Serum creatinine ? 1.5 x ULN
    ? Written informed consent prior to any study procedures being
    performed
    E.4Principal exclusion criteria
    Criterios de exclusión:
    • Deterioro conocido de la función cardíaca, incluyendo alguno de los siguientes acontecimientos:
    • LVEF < 45%
    • Bloqueo completo de rama izquierda
    • Bloqueo completo de rama derecha más hemibloqueo anterior izquierdo, bloqueo bifascicular
    • Uso de marcapasos ventricular
    • Síndrome congénito de QT prolongado
    • Historia de 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 selección. Si QTc > 450 mseg y los electrolitos no se encuentran dentro de los rangos de normalidad antes de la dosis de nilotinib, los electrolitos deberían ser corregidos y al paciente se le debería volver a analizar el QTc.
    • Infarto de miocardio dentro de los 12 meses previos al inicio de nilotinib.
    • Otra enfermedad cardíaca clínicamente significativa (por ejemplo, angina inestable, insuficiencia cardíaca congestiva, hipertensión incontrolada).
    • Antecedentes de pancreatitis crónica o aguda (es decir, durante el año previo al inicio de la medicación del estudio).
    • Otras condiciones médicas incontroladas concurrentes (por ejemplo, diabetes incontrolada, infecciones incontroladas o activas, enfermedad renal y hepática crónica o aguda) que pudiese causar riesgos de seguridad inaceptables o comprometer el cumplimiento con el protocolo.
    • Deterioro de la función gastrointestinal o enfermedad que pueda alterar 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).
    • Medicaciones concomitantes con prolongación potencial del QT (véase vínculo para la lista completa: http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm).
    • Medicaciones concomitantes que se conoce que son inductores o inhibidores potentes de la isoenzima del CYP450, CYP3A4: véase vínculo para la lista completa (http://medicine.iupui.edu/flockhart/table.htm)
    • Pacientes que hayan sido sometidos a cirugía mayor &#8804; 2 semanas antes del inicio de la medicación del estudio o que no se hayan recuperado de los efectos secundarios de dicha terapia.
    • Mujeres embarazadas o lactantes o mujeres físicamente fértiles que no utilicen un método anticonceptivo eficaz. (Las mujeres físicamente fértiles deberán presentar una prueba de embarazo en suero negativa durante los 14 días previos a la administración de nilotinib). Las mujeres postmenopáusicas deberán haber permanecido amenorreicas durante por lo menos 12 meses para ser consideradas físicamente no fértiles. Las mujeres deberán acceder a utilizar un método anticonceptivo eficaz de barrera durante el estudio y durante hasta 3 meses después de la retirada de la medicación del estudio.
    • Tratamiento con algún factor de crecimiento hematopoyético estimulante de colonias (por ejemplo, G-GSF, GM-CSF) &#8804; 1 semana antes del inicio de la medicación del estudio.
    • Diagnóstico conocido de infección por virus de la inmunodeficiencia humana (VIH) (la prueba del VIH no es obligatoria).
    • Pacientes con antecedentes de otra enfermedad maligna principal que actualmente sea clínicamente significativa o que precise intervención activa actualmente.
    • Pacientes que no quieran o no puedan cumplir con el protocolo.




    Known impaired cardiac function, including any of the following:
    LVEF < 45%
    - Complete left bundle branch block
    - Right bundle branch block plus left anterior hemiblock,
    bifascicular block
    - Use of a ventricular-paced pacemaker
    - Congenital long QT syndrome
    - History of or presence of clinically significant ventricular or
    atrial tachyarrhythmias
    - Clinically significant resting bradycardia (<50 beats per
    minute)
    - QTc>450 msec on screening ECG. If QTc > 450 msec and
    electrolytes are not within normal ranges before Nilotinib
    dosing, electrolytes should be corrected and then the patient
    rescreened for QTc criterion.
    - Myocardial infarction with 12 months prior to starting Nilotinib
    - Other clinical significant heart disease (e.g. unstable angina,
    congestive heart failure, uncontrolled hypertension)
    ? History of acute (i.e., within 1 year of starting study medication) or
    chronic pancreatitis
    ? Other concurrent uncontrolled medical conditions (e.g.,
    uncontrolled diabetes, active or uncontrolled infections, acute or
    chronic liver and renal disease) that could cause unacceptable
    safety risks or compromise compliance with the protocol
    ? Impaired gastrointestinal function or disease that may alter the
    absorption of study drug (e.g., ulcerative disease, uncontrolled
    nausea, vomiting and diarrhea, malabsorption syndrome, small
    bowel resection or gastric by-pass surgery)
    ? Concomitant medications with potential QT prolongation (see link
    for complete list: http://www.torsades.org/medical-pros/druglists/
    printable-drug-list.cfm)
    ? Concomitant medicati
    E.5 End points
    E.5.1Primary end point(s)
    Objetivo principal:
    • Evaluar la tasa de RMC después de 18 meses de tratamiento con nilotinib.


    The primary objective of the study is to evaluate the rate of CMR after 18 months of study treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic 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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA331
    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
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 743
    F.4.2.2In the whole clinical trial 806
    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 Decision2010-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-07
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