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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-000913-13
    Sponsor's Protocol Code Number:H3E-MC-S095
    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:2007-04-24
    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 number2007-000913-13
    A.3Full title of the trial
    Phase 2 Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

    Estudio Fase II de terapia concurrente con Carboplatino, Pemetrexed y Radioterapia para Cáncer de Pulmón Microcítico en Estadio Limitado
    A.4.1Sponsor's protocol code numberH3E-MC-S095
    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 SponsorLilly 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 Yes
    D.2.1.1.1Trade name Alimta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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.3.1Product nameAlimta
    D.3.2Product code LY231514
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpemetrexed
    D.3.9.1CAS number 150399-23-8
    D.3.9.2Current sponsor codeLY231514 disodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    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 Carboplatin
    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.3.1Product namecarboplatin
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarboplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    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 diagnóstico histopatológico o citológico de cáncer de pulmón microcítico estadio limitado que no han recibido quimioterapia o radioterapia previa.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10041069
    E.1.2Term Small cell lung cancer limited stage
    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 principal de este estudio en fase II es calcular la tasa de respuesta global tras el tratamiento con pemetrexed + carboplatino (en dosis de 500 mg/m2 y ABC objetivo de 5, respectivamente) y radiación concurrente (hasta una dosis acumulada de 50 Gy) en pacientes con LS-SCLC.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio en fase II son los siguientes:
    •Evaluar el tiempo hasta el acontecimiento para:
    Supervivencia Libre de Progresión
    Supervivencia global en un año
    Duración de la respuesta
    •Determinar la tasa de Respuestas Completas.
    •Evaluar la seguridad y caracterizar mejor los efectos tóxicos agudos y tardíos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1]Diagnóstico histológico y/o citológico de LS-SCLC, sin derrame pleural maligno demostrado citológicamente y limitado a un hemitórax (véase el Anexo al protocolo S095.3, Estadiaje del carcinoma pulmonar microcítico).
    [2]Estado funcional de 0 a 1 en la escala de estado funcional ECOG (Oken y cols. 1982) (véase el Anexo al protocolo S095.4., Escala del estado funcional ECOG).
    [3]Enfermedad medible, que se define por:
    •Debe haber al menos una lesión medible en una dimensión que cumpla los criterios de evaluación de la respuesta en los tumores sólidos (Response Evaluation Criteria in Solid Tumors) (RECIST; Therasse y cols. 2000) al menos 10 mm de diámetro mayor en tomografía computarizada (TC) espiral o al menos 20 mm con técnicas convencionales. No puede utilizarse la tomografía por emisión de positrones (PET) ni la ecografía.
    [4]Función orgánica adecuada, que comprenda lo siguiente:
    •Reserva de médula ósea adecuada: recuento absoluto de neutrófilos (RAN) (segmentados y cayados)  1,5  109/l, plaquetas 100  109/l y hemoglobina 9 g/dl.
    •Datos hepáticos: bilirrubina 1,5 veces el límite superior de la normalidad (LSN); fosfatasa alcalina (FA), aspartato transaminasa (AST) y alanina transaminasa (ALT) 3,0  LSN.
    •Datos renales: aclaramiento de creatinina (CrCl) calculado 45 ml/min según la fórmula estándar de Cockcroft y Gault (véase el Anexo al protocolo S095.5, Cálculo del aclaramiento de creatinina de Cockcroft y Gault).
    [5]Función pulmonar adecuada, definida como un volumen espiratorio forzado en 1 segundo (FEV1) > 30% del valor normal previsto y capacidad de difusión (DLCO) > 40% del valor normal previsto.
    [6]Documento de consentimiento informado firmado por el paciente.
    [7]Varones o mujeres de 18 o más años de edad.
    [8]Para mujeres: deben estar esterilizadas por cirugía o en período posmenopáusico, o deben utilizar un régimen anticonceptivo médicamente autorizado (p. ej., un dispositivo intrauterino [DIU], píldoras anticonceptivas o un anticonceptivo de barrera) durante el estudio y hasta transcurridos 6 meses desde la finalización del período de tratamiento; la prueba de embarazo en suero u orina realizada en un plazo máximo de 7 días antes de la inclusión en el estudio deberá ser negativa, y no podrán estar en período de lactancia.
    Para varones: deben estar esterilizados por cirugía o deben utilizar un régimen anticonceptivo durante el estudio y hasta transcurridos 6 meses desde la finalización del período de tratamiento.
    [9]Se requiere el cumplimiento del paciente y la proximidad geográfica que permitan realizar un seguimiento adecuado.
    [10]Esperanza de vida estimada como mínimo en 12 semanas.
    E.4Principal exclusion criteria
    [11]Han recibido tratamiento en los últimos 30 días con un fármaco que no ha obtenido la aprobación reguladora para ninguna indicación en el momento de la inclusión en el estudio.
    [12]Padecen un trastorno cardíaco grave, como un infarto de miocardio en los seis meses previos, angina o cardiopatía, de acuerdo con la definición de clase III o IV de la New York Heart Association (véase el Anexo al protocolo S095.6, Clasificaciones de la New York Heart Association).
    [13]Diagnóstico de un trastorno sistémico concomitante grave (p. ej., infección activa, incluyendo VIH) que, en opinión del investigador, comprometería la capacidad del paciente para completar el estudio.
    [14]Han recibido recientemente (en los 30 días anteriores al tratamiento del estudio) o de manera concurrente una vacuna contra la fiebre amarilla.
    [15]Han padecido un proceso maligno previo distinto al SCLC, carcinoma in situ de cuello uterino o cáncer cutáneo distinto al melanoma, salvo que haya sido diagnosticado y tratado definitivamente al menos 5 años antes sin signos posteriores de recidiva. Los pacientes con antecedentes de cáncer de próstata de bajo grado (puntuación de Gleason  6) localizado serán elegibles aunque el diagnóstico se haya efectuado menos de 5 años antes.
    [16]Quimioterapia previa para este cáncer y/o RTT previa.
    [17]Pacientes embarazadas o en período de lactancia.
    [18]Pérdida de peso importante ( 10%) en las 6 semanas previas a la inclusión en el estudio.
    [19]Administración concurrente de cualquier otro tratamiento antitumoral.
    [20]Incapacidad para interrumpir la administración de ácido acetilsalicílico u otros antiinflamatorios no esteroideos distintos a una dosis de ácido acetilsalicílico ≤ 1,3 gramos diarios, durante un período de 5 días (de 8 días para los fármacos de acción prolongada, como por ejemplo piroxicam).
    [21]Incapacidad o falta de disposición para recibir suplementos de ácido fólico o vitamina B12.
    [22]Incapacidad para tomar corticosteroides.
    [23]Finalización o retirada de este estudio o de cualquier otro estudio que investigue pemetrexed, carboplatino y/o RTT.
    [24]Incapacidad o falta de disposición para cumplir el protocolo o los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de respuesta global de pemetrexed y carboplatino con radioterapia concurrente
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 47
    F.4.2.2In the whole clinical trial 55
    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 Decision2007-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-20
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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
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