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    Summary
    EudraCT Number:2005-002911-26
    Sponsor's Protocol Code Number:H3E-SB-S089
    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:2006-01-23
    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 number2005-002911-26
    A.3Full title of the trial
    Estudio aleatorizado de fase 2 con pemetrexed, combinado con cisplatino o carboplatino, como quimioterapia adyuvante de pacientes con cáncer de pulmón no microcítico totalmente resecado en estadio Ib o II
    A Randomized Phase 2 Study of Pemetrexed in Combination with Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage Ib or II Non-Small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberH3E-SB-S089
    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 Information not present in EudraCT
    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 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.3.1Product 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Cisplatine
    D.2.1.1.2Name of the Marketing Authorisation holderBN229AG
    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.3.1Product namecisplatin
    D.3.4Pharmaceutical form Intravenous 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 INNcisplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name carboplatine
    D.2.1.1.2Name of the Marketing Authorisation holder3640AE, mijdrecht
    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.3.1Product namecarboplatin
    D.3.4Pharmaceutical form Intravenous 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberAUC5
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 pulmon no microcitico en estadios Ib, IIA, IIB, completamente resecado.
    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
    Evaluar la viabilidad de la quimioterapia adyuvante con pemetrexed, combinado con cisplatino o con carboplatino, en pacientes con CPNM en estadio Ib o IIa/IIb totalmente resecado. La viabilidad se define como la administración de pemetrexed, combinado aleatoriamente con cisplatino o carboplatino, durante 4 ciclos consecutivos, según se define en el protocolo.
    E.2.2Secondary objectives of the trial
    • Caracterizar los posibles efectos tóxicos cuantitativos y cualitativos y la necesidad de reducir la dosis y aplazar los ciclos como consecuencia de la toxicidad en cualquiera de las ramas de tratamiento.
    Evaluar los parámetros de eficacia (tiempo hasta diferentes acontecimientos) en las dos ramas de tratamiento, entre ellos
    •Supervivencia global (medida a los 3 años).
    •Supervivencia libre de enfermedad a los 3 años.
    •Evaluar los biomarcadores de interés para pemetrexed y el estado de enfermedad y su correlación con la evolución clínica (incluidas la supervivencia global, la supervivencia libre de enfermedad a los 3 años y la toxicidad).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Pacientes con CPNM en estadio Ib, IIa o IIb confirmado por histología tras resección quirúrgica completa (R0). Véase Apéndice al protocolo S089.3, Criterios para la estadificación del cáncer de pulmón del Comité Conjunto Norteamericano sobre el cáncer (Fleming y cols., 1997).
    [2]Resección tumoral completa del CPNM (R0) mediante neumonectomía o lobectomía (se excluye la resección sublobar o en cuña) con extirpación de cualquier ganglio linfático N1 afectado de 3 a 6 semanas antes del reclutamiento para el estudio.
    [3]Ausencia de N2 confirmada en el quirófano (con arreglo a la publicación “Regional Lymph Node Classification for Lung Cancer Staging” [Mountain y cols., 1997], véase referencia completa en la sección 11).
    [4]Categoría funcional de 0 a 1 en la escala de la ECOG (véase Apéndice al protocolo S089.4).
    [5]Ausencia de tratamiento antitumoral previo (quimio-, hormono-, inmunoterapia) para ese CPNM.
    [6]Ausencia de radioterapia previa de ese CPNM.
    [7]Cumplimiento del paciente y proximidad geográfica que garantice el seguimiento.
    [8]Función orgánica adecuada, que abarque todo lo siguiente:
    Reservas medulares suficientes: recuento absoluto de neutrófilos (segmentados y formas en banda) (RAN) 1,5 x 109/l, plaquetas 100 x 109/l y hemoglobina 9 g/dl.
    Hígado: bilirrubina 1,5 veces el límite superior de la normalidad ( LSN), fosfatasa alcalina (FA.), Aspartato transaminasa (AST) y Alanina transaminasa (ALT) 3,0  LSN.
    Función renal: aclaramiento de creatinina (CrCl) 45 ml/minuto calculado según la fórmula normalizada de Cockcroft y Gault (Apéndice al protocolo S089.5).
    [9]Firma del documento de consentimiento informado.
    [10]Edad mínima de 18 años.
    [11]Mujeres: las pacientes deben seguir una pauta anticonceptiva médicamente aprobada durante y hasta 6 meses después del tratamiento, además de mostrar un resultado negativo en la prueba de embarazo en suero o en orina y no estar en periodo de lactancia materna.
    Varones: los pacientes deben seguir una pauta anticonceptiva durante y hasta 6 meses después del período de tratamiento.
    E.4Principal exclusion criteria
    [12]Tratamiento durante los 30 últimos días con algún fármaco que no haya recibido la aprobación de las autoridades sanitarias para ninguna indicación en el momento de la inclusión en el estudio.
    [13]Terminación o abandono previos de este estudio o de cualquier otro estudio donde se investigue con pemetrexed.
    [14]Enfermedad general grave asociada (p. ej., infección activa, incluida la causada por el VIH) que, a juicio del investigador, dificulte al paciente la finalización del estudio.
    [15]Cualquier trastorno general asociado que impida o interfiera la administración de uno de los fármacos de la combinación (cisplatino, carboplatino, o ambos).
    [16]Complicaciones postoperatorias u otros estados relacionados con la cirugía que interfieran la participación en el estudio.
    [17]Rechazo o imposibilidad para tomar la suplementación de ácido fólico, vitamina B12 o la dexametasona (o corticoide equivalente); o cualquier otra imposibilidad para cumplir el protocolo o los procedimientos relacionados con el estudio.
    [18]Enfermedades malignas anteriores, distintas del CPNM, con la salvedad del carcinoma in situ del cuello uterino o del cáncer de piel no melanomatoso, salvo que se haya diagnosticado esa enfermedad maligna con anterioridad y tratado definitivamente al menos 5 años antes sin que quede ninguna señal de recidiva.
    [19]Enfermedad cardiovascular importante, a juzgar por una anomalía electrocardiográfica acompañada de signos clínicos de cardiopatía reciente o recurrente (por ejemplo, infarto de miocardio en los últimos 6 meses, angina de pecho o hipertensión no controlada).
    [20]Insuficiencia renal leve o moderada que impida interrumpir el tratamiento con salicilatos (como el ácido acetilsalicílico) u otros antiinflamatorios no esteroideos (AINE) durante un período de 5 días, a contar desde 2 días antes de la administración de pemetrexed (8 días en el caso de los preparados de larga acción, como el piroxicam). Excepción: se permitirá la administración ininterrumpida de aspirina (ácido acetilsalicílico) en dosis bajas (hasta 150 mg al día).
    [21 ]Derrame (pleural o peritoneal) con repercusión clínica, no susceptible de drenaje.
    [22]Embarazo o lactancia materna.
    [23]Administración simultánea de cualquier otro tratamiento antitumoral.
    [24] Vacunación concomitante o reciente contra la fiebre amarilla.
    E.5 End points
    E.5.1Primary end point(s)
    Administracion de pemetrexed combinado con cisplatino o carboplatino, durante 4 ciclos consecutivos segun el protocolo.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Viabilidad
    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 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) No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 final de ensayo clinico es la ultima visita del ultimo paciente en el ensayo, es decir la visita de seguimiento del ultimo paciente 3 años despues del reclutamiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 112
    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)
    Seguir los tratamientos locales para la enfermendad
    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 Decision2006-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
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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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