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    Summary
    EudraCT Number:2006-002267-11
    Sponsor's Protocol Code Number:CAMN107A2201
    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:2010-03-10
    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 number2006-002267-11
    A.3Full title of the trial
    Estudio multicéntrico, abierto, aleatorizado para evaluar la eficacia de nilotinib frente al mejor tratamiento de soporte con o sin un inhibidor de la tirosina quinasa (a elección del investigador), en pacientes adultos con tumores del estroma gastrointestinal resistentes tanto a imatinib como a sunitinib
    A.3.2Name or abbreviated title of the trial where available
    A2201
    A.4.1Sponsor's protocol code numberCAMN107A2201
    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 No
    D.2.5.1Orphan drug designation number
    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.3.11 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 AuthorisationAlbania
    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/3/01/061
    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.3.11 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: 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 Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 number
    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.3.11 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
    Tumores del Estroma Gastrointestinal (GIST)
    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
    •Evalular si la eficacia de nilotinib es superior al grupo control (mejor tratamiento de soporte con o sin imatinib o sunitinib), medido con la supervivencia libre de progresión.
    E.2.2Secondary objectives of the trial
    •Comparar la tasa de respuesta, tiempo transcurrido hasta la respuesta, duración de la respuesta y tiempo transcurrido hasta la progresión tumoral de nilotinib con el grupo control utilizando los criterios RECIST para evaluar la respuesta.
    •Comparar la supervivencia global de nilotinib con el grupo control.
    •Evaluar la seguridad y tolerabilidad de nilotinib, medido con la tasa y la severidad de los acontecimientos adversos.
    •Evaluar la farmacocinética de la población de nilotinib.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    •A los pacientes incluidos en los centros en los que se disponga de FDG-PET (aproximadamente 60 pacientes), se les realizarán FDG-PET para evaluar la respuesta metabólica tumoral en los dos esquemas de tratamiento distintos. Se realizará en la Visita 2 (día 1) y en la Visita 4 (día 28).
    E.3Principal inclusion criteria
    •Edad igual o superior a 18 años.
    •Diagnóstico histológicamente confirmado de GIST que sea inextirpable y/o metastásico y por lo tanto, no apto para cirugía o modalidad combinada con intento curativo antes de o en la Visita 1.
    •Confirmación radiológica de progresión de la enfermedad (criterios RECIST) durante la terapia con imatinib a una dosis de al menos 400 mg al día y confirmación radiológica de progresión de la enfermedad (criterios RECIST) durante la terapia con sunitinib, iniciada a una dosis diaria de 50 mg (incluso aunque la progresión de la enfermedad ocurriese con una dosis reducida) o intolerancia documentada (definida anteriormente) a imatinib y/o sunitinib.
    •Por lo menos una zona medible de la enfermedad con TAC/RM en la Visita 2, definido con los criterios RECIST (véase Anexo 3, para más detalles).
    •Estado funcional de la OMS de 0, 1 ó 2 en la Visita 1 y 2.
    •Los pacientes deberán presentar función de la médula ósea, de electrolitos y orgánica normal en la Visita 1 y 2, indicada con:
    1. Recuento de neutrófilos absoluto (ANC)  1.5 x 10 9/L
    2. Plaquetas  100 x 10 9/L
    3. ALT y AST ≤ 2.5 x límite superior de normalidad (ULN) o ≤ 5.0 x ULN, si se considera que es debido al tumor
    4. Fosfatasa alcalina ≤ 2.5 x ULN a menos que se considere que es debido al tumor
    5. Bilirrubina sérica ≤ 1.5 x ULN
    6. Lipasa y amilasa sérica ≤ 1.5 x ULN
    7. Potasio sérico ≥ límite inferior de normalidad (LLN) dentro de los límites de normalidad o corregible dentro de los límites de normalidad con suplementos para la Visita 2
    8. Calcio total ≥ LLN dentro de los límites de normalidad o corregible dentro de los límites de normalidad con suplementos en la Visita 2
    9. Magnesio sérico ≥ LLN dentro de los límites de normalidad o corregible dentro de los límites de normalidad con suplementos para la Visita 2
    10. Fósforo sérico ≥ LLN dentro de los límites de normalidad o corregible dentro de los límites de normalidad con suplementos para la Visita 2
    11. Creatinina sérica ≤ 1.5 x ULN o aclaramiento de creatinina de 24 horas ≥ 50 ml/min (se acepta el aclaramiento de creatinina calculado utilizando la fórmula de Cockroft-Gault).
    •Capacidad para comprender y que estén dispuestos a firmar un consentimiento informado por escrito
    E.4Principal exclusion criteria
    •Tratamiento previo con nilotinib
    •Tratamiento previo con nilotinib o con cualquier otro inhibidor de la tirosina quinasa o terapia dirigida, con la excepción de imatinib o sunitinib
    •Tratamiento con cualquier fármaco citotóxico en investigación y/o citotóxico ≤ 4 semanas (6 semanas para nitrosurea o mitomicina C) antes de la Visita 1, con la excepción de la terapia dirigida de sunitinib e imatinib
    • Enfermedades malignas concomitantes o previas (con una recaída en los últimos 5 años o que precisen tratamiento activo) que no sea GIST, con la excepción de cáncer cutáneo de células basales concomitante o previo o carcinoma cervical previo in situ
    • Deterioro de la función cardíaca en la Visita 1 ó 2, incluyendo algo de lo siguiente:
    1. LVEF < 45% o inferior al valor LLN establecido por el centro de investigación (eligiendo el que sea mayor), determinada con ecocardiograma en la Visita 1
    2. Bloqueo completo de rama izquierda
    3. Uso de un marcapasos cardíaco estimulado en el ventrículo
    5. Síndrome congénito de intervalo QT prolongado o antecedentes familiares de síndrome de QT prolongado
    6. Antecedentes o presencia de taquiarritmias auriculares o ventriculares significativas
    7. Bradicardia en reposo clínicamente significativa (< 50 pulsaciones por minuto)
    8. QTc > 450 mseg en el ECG de selección (utilizando la fórmula QTcF). Si el QTc > 450 mseg y los valores de electrolitos no se encuentran dentro de los límites de normalidad (los electrolitos deberían ser corregidos y al paciente se le debería volver a analizar el QTc)
    9. Bloqueo de rama derecha más hemibloqueo anterior izquierdo, bloqueo bifascicular
    10. Infarto de miocardio durante los 12 meses previos a la Visita 1
    12. Otras enfermedades cardíacas clínicamente significativas (por ejemplo, angina inestable, insuficiencia cardíaca congestiva o hipertensión incontrolada
    • Pacientes con enfermedades médicas incontroladas y/o severas concurrentes, que a juicio del investigador, pudiesen causar riesgos de seguridad inaceptables o comprometer el cumplimiento con el protocolo, por ejemplo, deterioro de la función gastrointestinal (GI) o enfermedad GI que pueda alterar significativamente la absorción de las medicaciones del estudio, diabetes incontrolada
    • Para los pacientes a los que se les realice una PET
    1. Incapacidad para permanecer tumbados en el escáner PET durante un máximo de una hora
    2. Ausencia de por lo menos una lesión metastásica mayor o igual a 2 cm en el TAC predosis o en otra imagen radiológica, definido con los criterios RECIST
    • Uso de derivados cumarínicos terapéuticos (es decir, warfarina, acenocumarol, fenprocumon)
    • Uso de cualquier medicación que prolongue el intervalo QT y de inhibidores del CYP3A4, si el tratamiento no puede ser interrumpido de forma segura o cambiado a una medicación distinta antes de iniciar la administración de la medicación del estudio. Por favor, véase http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm para una lista completa de los fármacos que prolongan el intervalo QT además del Anexo 2.
    • Pacientes que hayan sido sometidos a cirugía mayor ≤ 2 semanas antes de la Visita 1 o que no se hayan recuperado de los efectos secundarios de dicho tratamiento.
    • Pacientes que hayan recibido radioterapia de campo extenso ≤ 4 semanas o radioterapia de campo limitado paliativa < 2 semanas antes de la Visita 1 o que no se hayan recuperado de los efectos secundarios de dicho tratamiento.
    • Antecedentes de incumplimiento de regímenes médicos o que no puedan o no quieran regresar a las visitas programadas.
    • Pacientes embarazadas o lactantes o físicamente fértiles (WOCBP). Las mujeres postmenopáusicas deberán haber permanecido amenorréicas durante por lo menos 12 meses para ser consideradas físicamente no fértiles. Las mujeres físicamente fértiles, incluyendo las parejas femeninas de pacientes heterosexuales o bisexuales, deberán acceder a utilizar un método anticonceptivo eficaz durante el estudio y durante tres meses después de la finalización del estudio.
    • Pacientes que no quieran o que no puedan cumplir con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia Libre de progresión (PFS)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    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) 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 Information not present in EudraCT
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Patients with diseas progress on the control arm will be allowed to crossover to the nilotinib arm.
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    The cut-off date for the final primary analysis of progression free survival will be when 136 progression free survival events have occured or alternatively when the last remaining patient drops out, progress or completes a minimum of 32 weeks of dosing, whichever comes first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    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 Decision2007-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
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