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    Summary
    EudraCT Number:2009-016922-15
    Sponsor's Protocol Code Number:HSJD-IMANF1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-11-19
    Trial 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 number2009-016922-15
    A.3Full title of the trial
    ENSAYO PILOTO CON IMATINIB PARA PACIENTES CON NEUROFIBROMA PLEXIFORME ASOCIADO A LA NEUROFIBROMATOSIS TIPO I.
    PILOT STUDY WITH IMATINIB FOR PLEXIFORM NEUROFIBROMA IN NEUROFIBROMATOSIS TYPE I PATIENTS
    A.4.1Sponsor's protocol code numberHSJD-IMANF1
    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 SponsorHOSPITAL SANT JOAN DE DÉU
    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 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 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 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 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.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.2.1.1.1Trade name GLIVEC 400 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 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 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 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 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
    Tratamiento de los neurofibromas plexiformes de alto riesgo no abordables quirúrgicamente en pacientes con neurofibromatosis tipo I
    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
    Determinar la eficacia de imatinib en los neurofibromas de niños y adolescentes diagnosticados de neurofibromatosis tipo I.
    E.2.2Secondary objectives of the trial
    1. Determinar la seguridad y tolerancia de imatinib en estos pacientes
    2. Determinar los cambios en cualquiera de las otras lesiones (glioma de nervio óptico, lesiones brillantes cerebrales, otros tumores).
    3. Cuantificar el estado de salud de los pacientes.
    4. Permitir la obtención, conservación y empleo de muestras para investigar posibles asociaciones entre NF1 y respuesta a imatinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnóstico de Neurofibromatosis tipo 1 según los criterios revisados (Apéndice 1).
    2. Diagnóstico de Neurofibroma/Neurofibroma plexiforme de alto riesgo (*) no extirpable de forma completa
    3. Enfermedad mensurable radiológicamente.
    4. Edad de inclusión de 12 meses a 18 años, ambos inclusive
    5. Estatus general correspondiente a escala de Lansky &#8805; 70% en menores de 12 años o a escala Karnofsky &#8805; 70% en mayores de esa edad o ECOG > 2 (Apéndice 2).
    6. Adecuada función orgánica, incluyendo la función hematológica (Hemoglobina > 10 g/dl, Leucocitos > 3000 /mm3, Plaquetas > 100.000 / mm3), renal (Creatinina sérica < 1,5 mg/dl) y hepática (bilirrubina total, AST, ALT inferior a 2 veces el límite superior del rango normal del laboratorio).
    7. Los sujetos con potencial reproductor realizarán un método efectivo de control de natalidad durante todo el estudio. Las mujeres en edad reproductora se incluirán tras la negatividad de la prueba de embarazo.
    8. Consentimiento informado de los padres/representante legal, y consentimiento informado del menor maduro.
    (*) Alto riesgo:
    - Lesiones > 5 cm de diámetro mayor
    - Rápido crecimiento con potencial compromiso de estructuras vitales
    - Lesiones sintomáticas (dolor crónico o alteración funcional)
    - Lesiones con invasión de canal medular o que involucra múltiples raices nerviosas de &#8805; 3 niveles espinales conectados
    - Lesiones desfigurantes
    E.4Principal exclusion criteria
    1. Embarazo o lactancia.
    2. Tratamiento en otro ensayo clínico.
    3. Presencia de una infección no controlada.
    4. Cualquier enfermedad concomitante grave que en la opinión del investigador pueda comprometer completar el estudio o afectar la tolerancia del paciente para este tratamiento.
    4. Tratamiento previo con cualquier fármaco biológico/investigacional en los últimos 3 meses.
    5. Tratamiento quimioterápico las 4 semanas previas.
    6. Radioterapia que abarque el 25% o más de la médula ósea.
    7. El paciente no debe haberse sometido a cirugía mayor en los 14 días previos al inicio del tratamiento
    8. Hipersensibilidad al prinicipio activo del fármaco en investigación o a cualquiera de sus excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    Determinar la tasa de respuestas objetivas de imatinib en los neurofibromas de niños y adolescentes diagnosticados de neurofibromatosis tipo I.
    La tasa de respuestas objetivas al tratamiento se determinará mediante análisis de RM cada 6 meses.

    Se considerará:

    Muy buena respuesta: Disminución de más de un 20% del tamaño tumoral original.
    Buena respuesta: Cualquier tipo de reducción en el tamaño de la masa. Cualquier tipo de mejoría objetiva de los síntomas si éstos estaban presentes al inicio del tratamiento.
    Respuesta parcial: Estabilidad o disminución de la velocidad de crecimiento de la lesión sin ningún tipo de mejoría objetiva de los síntomas presentes al inicio del tratamiento.
    Mala respuesta: Progresión de la enfermedad.

    Si en la evaluación final a los 12 meses, se constata que persiste esta Buena o Muy Buena Respuesta se podrá continuar el tratamiento hasta confirmar ausencia de mejoría clínica o radiológica en un periodo de 6 meses.

    En el caso de una Respuesta Parcial se valorará individualmente la situación de cada paciente. En caso de decidirse la adición de cualquier otro tipo de tratamiento al fármaco en investigación, el paciente no será valorable para el objetivo primario del mismo. Será seguido a efectos de seguridad exclusivamente, durante un máximo de tres años. En estos casos, se valorarán los acontecimientos adversos y tratamientos recibidos.
    En el caso de Mala Respuesta el paciente será excluido del estudio.
    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 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) 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    La duración del estudio será de 1 año, durante el cual se administrará el fármaco. Posteriormente, se hará un seguimiento de los pacientes hasta un periodo de 3 años desde la administración de la última dosis del fármaco en estudio.
    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 months0
    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 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-11-19. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Menores de edad
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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 Decision2010-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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