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    Summary
    EudraCT Number:2013-002200-13
    Sponsor's Protocol Code Number:CBGJ398X2201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-12-27
    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 number2013-002200-13
    A.3Full title of the trial
    A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma.
    Estudio fase 2, multicéntrico, abierto de BGJ398 en pacientes con glioblastoma recurrente resecable o irresecable.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 study of BGJ398 in patients with recurrent GBM.
    Un estudio fase 2 de BGJ398 en pacientes con GBM recurrente.
    A.4.1Sponsor's protocol code numberCBGJ398X2201
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico Oncología (GMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.com
    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 nameBGJ398 25 mg
    D.3.2Product code BGJ398
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNBGJ398
    D.3.9.2Current sponsor codeBGJ398
    D.3.9.3Other descriptive nameBGJ398
    D.3.9.4EV Substance CodeSUB31319
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 nameBGJ398 100 mg
    D.3.2Product code BGJ398
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNBGJ398
    D.3.9.2Current sponsor codeBGJ398
    D.3.9.3Other descriptive nameBGJ398
    D.3.9.4EV Substance CodeSUB31319
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    recurrent resectable or unresectable Glioblastoma.
    Glioblastoma recurrente resecable o irresecable.
    E.1.1.1Medical condition in easily understood language
    A phase 2 study of BGJ398 in patients with recurrent glioblastoma.
    Estudio fase 2 de BGJ398 en pacientes con glioblastoma recurrente.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator)
    Evaluar la actividad antitumoral de BGJ398 para pacientes con GBM con una translocación o amplificación en FGFR1, 2, 3 ó 4, basado en la SLP6.
    E.2.2Secondary objectives of the trial
    1) To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Overall Response Rate (ORR - patients with measurable disease -as defined by RANO criteria as assessed by the investigator
    2) To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Overall Survival
    3) Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose
    interruptions, reductions and dose intensity, and evaluations of laboratory values
    1.- Evaluar la actividad antitumoral de BGJ398 para pacientes con GBM con una translocación o amplificación en FGFR1, 2, 3 ó 4, basado en la TRG.
    2.- Evaluar mejor la a actividad antitumoral de BGJ398 para pacientes con GBM con una translocación o amplificación en FGFR1, 2, 3 ó 4, basado en la SG.
    3.- Caracterizar la seguridad y la tolerabilidad de BGJ398.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Patients with histologically confirmed GBM at the time of diagnosis or prior relapse.
    2) Documentation of amplification, translocation, or activating mutation to FGFR1, FGFR2, or FGFR3, or FGFR4
    3) RANO defined tumor progression by MRI in comparison to a prior scan
    4) Patients must have received prior external beam radiotherapy and temozolomide.
    Other protocol defined criteria may apply
    1. Pacientes con GBM histológicamente confirmado en el momento del diagnóstico o antes de la recaída. Recuerde que se permiten todos los subtipos de GBM (por ejemplo, gliosarcoma). Los pacientes serán elegibles si la histología original fue de glioma de grado bajo y se realizó un diagnóstico histológico posterior de GBM. Cualquier duda sobre la elegibilidad debería ser comentada con Novartis.
    2. Deberá disponerse de por lo menos 15 ó 20 secciones no teñidas y/o un bloque de tumor de por lo menos una cirugía deberá disponerse para análisis molecular, excepto que Novartis y el investigador acuerden lo contrario.
    3. Se requiere documentación por escrito de determinación de laboratorio central o local de amplificación o translocación a FGFR1, FGFR2, FGFR3 o FGFR4. Los pacientes a los que se identifique que presentan una mutación activada en FGFR 1, 2, 3 ó 4 pueden ser elegibles, pendiente de acuerdo entre Novartis y el investigador.
    4. Progresión del tumor definida con los criterios RANO con RM en comparación con un escáner previo; O, progresión que no cumple los criterios RANO pero la progresión de la enfermedad es obvia a criterio del investigador y es comentado con Novartis; O enfermedad progresiva/recurrente demostrada histológicamente basada en histología, si la cirugía fue el tratamiento para la progresión más reciente.
    5. Los pacientes deberán haber recibido radioterapia de haz externo y temozolomida previamente.
    6. Los tratamientos previos permitidos incluyen:
    a. Cirugía previa (número ilimitado).
    b. Se permite un máximo de dos regímenes previos de quimioterapia (incluyendo bevacizumab) para enfermedad recurrente.
    7. Inclusión específica de grupo:
    Grupo 1: progresión del tumor definida con RANO según el criterio de inclusión 4. Además, los pacientes sometidos recientemente a resección por progresión del tumor definida con RANO también pueden ser elegibles para el grupo 1, asumiendo que cumplan todos los criterios de inclusión/exclusión y la cirugía más reciente haya ocurrido dentro de las seis semanas de la primera dosis prevista del tratamiento.
    Grupo 2: progresión del tumor definida con RANO según el criterio de inclusión 4 y resección quirúrgica prevista. Además, si un paciente asignado al grupo 2 no es sometido a la resección quirúrgica prevista, entonces el paciente podrá continuar la terapia igual que el grupo 1. Si un paciente en el grupo 2 precisa ser sometido a resección quirúrgica antes de lo inicialmente previsto (y ha recibido menos de 5 días de BGJ398), entonces el paciente aún podrá continuar la terapia postquirúrgicamente igual que el grupo 2, independientemente del número de días que el paciente recibió BGJ398 pre-quirúrgicamente.
    E.4Principal exclusion criteria
    1) History of another primary malignancy
    2) Prior or current treatment with a FGFR inhibitor
    3) Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
    4) Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment.
    Other protocol defined criteria may apply
    1. Antecedentes de otra enfermedad maligna primaria excepto: carcinoma in situ de cualquier tipo que haya sido tratado adecuadamente; o carcinoma no melanomatoso cutáneo; o cualquier otra enfermedad maligna tratada curativamente que no haya sido tratada en los 3 meses previos o que se prevea que precisa tratamiento para recurrencia durante el transcurso del estudio; o cualquier malignidad indolente que no precise tratamiento dentro de los 2 años previos (incluso si nunca fue tratada previamente).
    2. Tratamiento previo o actual con un inhibidor de FGFR (excepto que entre el investigador y Novartis se acuerde lo contrario en una base individualizada).
    3. Síntomas neurológicos relacionados con enfermedad subyacente que precisen aumento de dosis de corticosteroides. Nota: El uso de esteroides para el manejo de tumores del SNC está permitido pero deberá ser a una dosis estable durante por lo menos 2 semanas antes de la TC/RM basal. Si la dosis de corticosteroides se aumenta entre la fecha de la imagen y el inicio del tratamiento del estudio, se precisa una nueva TC/RM basal. La definición de esteroides estables incluye pacientes sin esteroides.
    4. Los pacientes no deberán recibir fármacos antiepilépticos inductores
    enzimáticos (EIAED) (Remítase al Suplemento 2 para la lista de
    medicaciones prohibidas). Si ha sido tratado previamente con un EIAED, el
    paciente deberá haberlo suspendido durante por lo menos 2 semanas antes del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    progression free survival
    supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    1) Overall response rate
    2) Overall survival
    3) safety and tolerability
    1) Tasa de respuesta global
    2) La supervivencia global
    3) Seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 8 months after LPLV
    2) 8 months after LPLV
    3) 8 months after LPLV
    1) 8 meses después de la última visita del último paciente (LPLV)
    2) 8 meses después de la última visita del último paciente (LPLV)
    3) 8 meses después de la última visita del último paciente (LPLV)
    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 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) 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 No
    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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Italy
    Netherlands
    Sweden
    Australia
    Germany
    Spain
    Switzerland
    United States
    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
    End of study will be upon completion of the follow up period for the last patient treated. This will be either upon study completion of the last patient treated or once the last patient has expired or all patients have completed the study and have been followed for at least one year after their first dose of study treatment, have been lost to follow-up, or withdrew consent, whichever occurs first.
    El fin del estudio será una vez finalizado el periodo de seguimiento del último paciente tratado. Lo que ocurra primero de los siguientes casos: una vez que el último paciente haya sido tratado o una vez que el último paciente ha caducado o que todos los pacientes que han completado el estudio y han sido seguidos durante al menos un año después de la primera dosis del tratamiento del estudio, se han perdido en el seguimiento, o se retiró el consentimiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 32
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguo
    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 Decision2014-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-03
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