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    Summary
    EudraCT Number:2006-003568-73
    Sponsor's Protocol Code Number:GECP06/01
    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:2010-03-05
    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 number2006-003568-73
    A.3Full title of the trial
    Estudio fase III, multicéntrico, abierto, randomizado de tratamiento con erlotinib (Tarceva®) versus quimioterapia en pacientes con carcinoma no microcítico de pulmón avanzado que presentan mutaciones en el dominio tirosina quinasa (TK) del Receptor del Factor de Crecimiento Epidérmico (EGFR)

    A phase III, multicenter, open-label, randomized trial of erlotinib (Tarceva®) versus chemotherapy in patients with advanced non-small cell lung cancer with mutations in the tyrosine kinase domain of the Epidermal Growth Factor Receptor (EGFR)
    A.4.1Sponsor's protocol code numberGECP06/01
    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 SponsorGrupo Español de Cáncer de Pulmón
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNErlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo50-8231/OSI-774
    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) 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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNErlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo05-08231/OSI-774
    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: 3
    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 Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNErlotinib
    D.3.9.1CAS number 183319-69-9
    D.3.9.2Current sponsor codeRo05-08231/OSI-774
    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
    Cáncer de pulmón no microcítico avanzado (estadios IIIB-IV)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la supervivencia libre de progresión, evaluada por el investigador, en los dos brazos de tratamiento del estudio (quimioterapia convencional versus erlotinib) en pacientes con cáncer de pulmón no microcítico (CPNM) en estadios avanzados (estadio IIIB y estadio IV), que no han recibido quimioterapia previa para su enfermedad y que presentan mutaciones en el dominio tirosina quinasa del receptor del factor de crecimiento epidérmico (EGFR).
    E.2.2Secondary objectives of the trial
    • Respuesta objetiva evaluada por el investigador
    • Supervivencia global (incluidas las tasas de supervivencia al cabo de uno y dos años)
    • Localización de la progresión
    • Perfil de seguridad
    • Análisis de mutaciones génicas del EGFR en suero
    • Calidad de vida (LCSS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Antes del comienzo de los procedimientos específicos del protocolo, deberá obtenerse y documentarse el consentimiento informado escrito u oral ante testigos.
    2. Diagnóstico histológico de cáncer de pulmón no microcítico (CPNM), estadio IV o estadio IIIB con derrame pleural maligno o tumores N3 no candidatos a recibir radioterapia torácica, que presenten deleciones en el exón 19 o mutación en el exón 21 en el dominio tirosina quinasa del EGFR
    3. Enfermedad medible o evaluable.
    4. Pacientes mayores de 18 años.
    5. Estado funcional < 2 en la escala de ECOG.
    6. Adecuada reserva medular:
    a. Hemoglobina ≥ 9 g/dL
    b. Cifra absoluta de neutrófilos > 1.500/μL.
    c. Recuento de plaquetas > 100.000/μL.
    7. Adecuada función renal: creatinina sérica < 1,5 x límite superior de la normalidad (LSN) o aclaramiento calculado de creatinina (CrCl) > 60 ml/min usando la fórmula de Cockcroft-Gault:
    a. Hombres: CrCl = (140 –edad) x peso/(72 x creatinina en suero)
    b. Mujeres: CrCl = [(140 – edad) x peso/(72 x creatinina en suero)] x 0,85.
    Si no presenta adecuada función renal, se administrará carboplatino y se utilizará la fórmula de Calvert para el cálculo de la dosis teniendo en cuenta el AUC planificada.
    DOSIS TOTAL (*) DE CBDCA A ADMINISTRAR = AUC x (GFR + 25)
    GFR = Aclaramiento de creatinina en orina de 24 horas, con diuresis superior a 2.000 cc/24 horas.
    8. Adecuada función hepática:
    a. Bilirrubina total < LSN.
    b. ASAT (SGOT) y/o ALAT (SGPT) < 2.5 x LSN.
    c. Fosfatasa alcalina < 5 LSN, excepto en presencia de únicamente metástasis óseas y en ausencia de cualquier trastorno hepático.
    9. Los pacientes deberán estar accesibles para el tratamiento y el seguimiento.
    10. Pacientes capaces de realizar un adecuado cumplimiento terapeútico y accesibles para su correcto seguimiento.
    11. Las mujeres en edad fértil deben tener una prueba de embarazo negativa en suero u orina dentro de los 7 días previos al inicio del tratamiento.
    12. Los pacientes de ambos sexos en edad fértil, incluyendo las mujeres que hayan tenido la última menstruación hace menos de 2 años, deben utilizar un método anticonceptivo adecuado.
    13. Posibilidad de deglución oral.
    14. Los pacientes con metastásis cerebrales asintomáticas y estables con tratamiento médico serán elegibles para el estudio. También serán elegibles pacientes que hayan recibido tratamiento con radioterapia para sus metástasis cerebrales antes del inicio del tratamiento sistémico para el cáncer de pulmón no microcítico.
    15. Ausencia de problemas de tránsito intestinal, como síndrome de malabsorción, enfermedad inflamatoria crónica intestinal u otras patologías que, a criterio de investigador, puedan alteral la absorción del medicamento.
    E.4Principal exclusion criteria
    1. Pacientes embarazadas o en periodo de lactancia.
    2. Mujeres potencialmente fértiles que presenten un resultado positivo en la prueba de embarazo de la evaluación basal o que no hayan realizado dicha prueba.
    3. Varones y mujeres sexualmente activos (en edad fértil) que no estén dispuestos a utilizar métodos anticonceptivos durante el estudio.
    4. Tratamiento previo con quimioterapia para enfermedad metastásica. Se permite la administración de quimioterapia neoadyuvante o adyuvante siempre y cuando esta haya finalizado ≥ 6 meses antes de la entrada en el estudio.
    5. Tratamiento previo con agentes terapeúticos dirigidos hacia el EGFR.
    6. Los pacientes pueden haber recibido radioterapia, siempre que la lesión irradiada no sea la única lesion diana para evaluar la respuesta y siempre que se haya completado la radioterapia antes de iniciar el tratamiento del estudio ( se recomienda un periodo de 2 semanas).
    7. Tratamiento con un agente farmacológico experimental durante las 3 semanas previas a la inclusión en el estudio.
    8. Cualquier anomalía oftalmológica significativa conocida de la superficie ocular.No se recomienda el uso de lentes de contacto
    9. Neurotoxicidad motora o sensorial preexistente en grado > 2 según la escala NCI-CTC.
    10. Evidencia de compresión de médula espinal.
    11. Incapacidad para tomar la medicación oral o procedimientos quirúrgicos previos que afecten a la absorción e impliquen la necesidad de alimentación intravenosa o parenteral.
    12. Otras enfermedades o condiciones clínicas graves, incluidas, pero no limitadas a:
    a. Cardiopatía inestable a pesar del tratamiento, infarto de miocardio durante los 6 meses anteriores a la inclusión en el estudio.
    b. Antecedentes de trastornos neurológicos o psiquiátricos significativos, incluida demencia y ataques epilépticos.
    c. Infección activa no controlada.
    d. Úlcera péptica activa no controlada.
    e. Diabetes mellitus inestable o cualquier otra contraindicación para el uso de corticoides.
    f. ASAT y/o ALAT > 1,5 x LSN asociada a fosfatasa alcalina > 2,5 x LSN.
    g. Enfermedad pulmonar obstructiva crónica que hubiese requerido hospitalización durante el año anterior.
    h. Otros procesos médicos subyacentes graves que pudieran afectar la capacidad del paciente para participar en el estudio.
    13. Contraindicación absoluta para el uso de esteroides.
    14. Demencia o estado mental significativamente alterado que pudiera interferir en la comprensión y otorgamiento del consentimiento informado.
    15. Historia de otra neoplasia a excepción de carcinoma in situ de cervix, carcinoma cutáneo basocelular tratado adecuadamente, carcinoma de próstata de buen pronóstico (Gleason ≤ 6) tratado radicalmente. Historia de otra neoplasia tratada curativamente y sin evidencia de enfermedad en los últimos 5 años.
    E.5 End points
    E.5.1Primary end point(s)
    Comparar la supervivencia libre de progresión, evaluada por el investigador, en los dos brazos de tratamiento del estudio (quimioterapia convencional versus erlotinib) en pacientes con cáncer de pulmón no microcítico (CPNM) en estadios avanzados (estadio IIIB y estadio IV), que no han recibido quimioterapia previa para su enfermedad y que presentan mutaciones en el dominio tirosina quinasa del receptor del factor de crecimiento epidérmico (EGFR)
    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 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 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 No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned52
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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 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
    La terminación del ensayo clínico tendrá lugar en la fecha de fallecimiento del último paciente vivo del estudio.
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 173
    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)
    No distinto del tratamiento habitual
    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 Decision2006-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
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