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    Summary
    EudraCT Number:2008-001546-67
    Sponsor's Protocol Code Number:1200.41
    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:2009-03-10
    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 number2008-001546-67
    A.3Full title of the trial
    Ensayo clínico de Fase II, de un solo brazo de tratamiento, con BIBW 2992 (Tovok?) en pacientes con cáncer de pulmón no microcítico seleccionados demográficamente y genotípicamente.

    A Phase II single-arm trial of BIBW 2992 in demographically and genotypically selected non-small cell lung cancer patients
    A.4.1Sponsor's protocol code number1200.41
    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 SponsorBoehringer Ingelheim España 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 nameTOVOK
    D.3.2Product code BIBW 2992
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeBIBW 2992
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 nameTOVOK
    D.3.2Product code BIBW 2992
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeBIBW 2992
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 con cancer de pulmón no microcítico en estadío IIIB / IV
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo primario de este estudio de Fase II, abierto, de un sólo brazo de tratamiento es la evaluación de la eficacia de BIBW 2992 definido como la tasa de respuesta objetiva (Respuesta Completa, Respuesta Parcial) determinada por los criterios RECIST en pacientes con cancer de pulmon no microcítico avanzado, estadío IIIB o IV cuyo tumor contenga mutaciones activadoras en los exones 18 a 21 del receptor EGFR, mutaciones del receptor HER2/neu, y tumores positivos para FISH en el receptor EGFR sin detección de mutaciones en el EGFR.
    E.2.2Secondary objectives of the trial
    ?Control de la enfermedad (Remisión Completa, Respuesta Parcial, Enfermedad Estable) determinado por RECIST
    ?Supervivencia libre de progresión
    ?Parámetros Farmacocinéticos de BIBW 2992
    ?Seguridad de BIBW 2992 determinado por la intensidad e incidencia de acontecimientos adversos, según los criterios CTCAE Version 3.0, especialmente reacciones cutáneas y efectos gastro-intestinales
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Pacientes con confirmación anatomopatológica de diagnóstico de cancer de pulmón no microcítico estadío IIIB/IV (con derrame pleural); con clasificación histopatológica de adenocarcinoma o carcinoma broncoalveolar.
    2.Pacientes no fumadores que hayan fumado menos de 15 paquetes-año y que hayan dejado de fumar al menos 1 año antes del diagnóstico (para las cohortes 1 y 2).
    3. Presencia de mutaciones activadoras en el exon 18 a 21 del receptor EGFR o HER2/neu confirmado mediante secuenciación directa de ADN de tejido del tumor o por un aumento en el numero de copias del gen EGFR determinado por análisis FISH.
    4. Tratamiento previo:
    ?Cohorte 1: enfermedad progresiva después de un tratamiento con un inhibidor reversible de la Tyrosina kinasa EGFR admisnistrado posteriormente a la detección de la mutación activadora en el receptor EGFR.
    ?Cohorte 2: no tratamiento previo con inhibidores de la Tyrosina kinasa EGFR, hasta 3 líneas de quimioterapia (incluyendo tratamiento adyuvante)
    ?Cohorte 3: sin restricciones
    5. Pacientes con al menos una lesión tumoral que pueda ser medida con exactitud mediante tomografía computerizada (TC) o imágenes de resonancia magnética (RMN) en al menos una dimensión. El diámetro mayor a registrar debe ser ?20 mm si se utilizan técnicas convencionales o ?10 mm en caso de utilizarse la TC helicoidal.
    6. Hombres o mujeres ?18 años
    7. Esperanza de vida mínima de 3 meses
    8. Consentimiento informado por escrito según las normas GCP de las ICH
    9. Eastern Cooperative Oncology Group (ECOG) grado 0, 1 o 2
    E.4Principal exclusion criteria
    1. Más de 3 regimenes de tratamiento quimioterápico citotóxico para el cancer de pulmon no microcítico en recaída o metastático, excepto en pacientes con mutaciones del HER2/neu que pueden haber recibido cualquier terapia previa
    2. Quimioterapia, hormonoterapia (distinta a Megace® o tratamiento esteroideo requeridos para el tratamiento de mantenimiento no antineoplásico) o inmunoterapia en las últimas 4 semanas o dentro de un periodo menor a 4 vidas medias del tratamiento previo antes del inicio de la medicación del estudio y/o persistencia de toxicidades de terapias antineoplásicas previas que sean clínicamente significativas.
    3. Metastásis cerebrales sintomáticas; los pacientes con metástasis cerebrales asintomáticas bajo tratamiento son elegibles para el estudio si presentan una enfermedad cerebral estable durante al menos 4 semanas sin requerir tratamiento esteroideo o antiepiléptico.
    4. Transtornos gastro-intestinales agudos recientes o clínicamente significativos con diarrea como síntoma principal, por ejemplo Enfermedad de Crohn, malabsorción o diarrea de grado CTCAE>2 de cualquier etiología en el momento basal.
    5. Cualquier otra enfermedad o disfunción orgánica sistémica que pueda poner en peligro la vida del paciente y que, en opinion del investigador podría comprometer la seguridad del paciente o interferir en la evaluación de la seguridad de la medicación del estudio.
    6. Otros cánceres diagnosticados durante los últimos 5 años (distintos al cáncer de piel no melanomatoso o al cáncer de cuello uterino in situ)
    7. Radioterapia durante las 2 semanas anteriores al inicio del tratamiento con el fármaco de estudio
    8.Pacientes con una infección activa grave (por ejemplo, que requiera tratamiento antibiótico vía endovenosa, tratamiento antifúngico, o agentes antivirales).
    9.Pacientes con infección conocida por el VIH, hepatitis B activa o hepatitis C activa.
    10.Existencia o sospecha de alcoholismo o drogadicción.
    11. Mujeres y hombres en edad fértil no dispuestos a utilizar un método anticonceptivo fiable durante el ensayo.
    12.Embarazo o período de lactancia.
    13.Pacientes incapaces de cumplir con el protocolo.
    14. Antecedentes de cardiopatía no controlada o clínicamente significativa, entre ellas la insuficiencia cardiaca congestiva, angina de pecho, infarto de miocardio, arritmia, inclusive una clasificación funcional de grado 3 según la New York Heart Association (NYHA) .
    15.Función ventricular izquierda con una fracción de eyección en reposo inferior al 50% mediante una ventriculografía isotópica (MUGA) o un ecocardiograma.
    16. Recuento absoluto de neutrófilos (ANC) < 1500/mm³.
    17. Recuento de plaquetas < 100 000 / mm³.
    18. Bilirrubina > 1.5 mg / dl (>26 µmol / L, equivalente en unidades SI).
    19. Niveles de aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 3 veces el límite superior de la normalidad (en relación con metástasis hepáticas > 5 veces el límite superior de la normalidad).
    20.Niveles de creatinina sérica > 1,5 veces el límite superior de la normalidad
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal de este estudio es la tasa de respuesta objetiva (Respuesta Completa, Respuesta Parcial) determinada por los criterios RECIST
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    El ensayo clínico se considerará finalizado en el momento en que el último paciente haya realizado la última visita, incluyendo las visitas de seguimiento.
    En caso de que el promotor del ensayo decida terminar el estudio por razones de seguridad, los pacientes no continuarán con el tratamiento de 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 months8
    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 months5
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2009-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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