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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2006-006429-24
    Sponsor's Protocol Code Number:H3E-XM-S113
    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:2007-03-08
    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 number2006-006429-24
    A.3Full title of the trial
    Ensayo Fase II de Pemetrexed más Cisplatino como tratamiento de pacientes con cáncer microcítico de pulmón, enfermedad extendida
    A.4.1Sponsor's protocol code numberH3E-XM-S113
    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 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 namePemetrexed
    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.3.11 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.2.1.2Country 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 nameCisplatino
    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.3.11 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 microcítico de pulmón, enfermedad extendida
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar tasa de respuesta tras 6 ciclos de terapia combinada de pemetrexed más cisplatino en pacientes con CPM-EE
    E.2.2Secondary objectives of the trial
    • Evaluar la tolerancia y toxicidad del tratamiento.
    • Evaluar la supervivencia global
    • Evaluar el supervivencia libre de progresión de la enfermedad
    • Evaluar la duración del tiempo de respuesta tumoral
    • Tasa de estabilizaciones
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnóstico histológico o citológico de CPM-EE, incluido el derrame pleural maligno.
    Estado funcional de 0 a 2 en la escala de estado funcional ECOG.
    Ausencia de quimioterapia sistémica, inmunoterapia o terapia biológica para el CPM.
    Se permite la radioterapia previa de <25% de la médula ósea. Los pacientes que hayan recibido radiación previa de la pelvis total o del tórax para el tratamiento del CPM no son elegibles. La radioterapia previa debe darse por concluida al menos 2 semanas antes del reclutamiento en el estudio. Los pacientes se deberán haber recuperado de los efectos tóxicos agudos del tratamiento antes de su reclutamiento en el estudio.
    Debe haber al menos una lesión medible en una dimensión que cumpla los criterios de evaluación de la respuesta en los tumores sólidos (RECIST). Una lesión medible se define como una lesión que puede ser medida con precisión al menos en una dimensión y es > o igual a 20 mm con técnicas convencionales o es > o igual a 10 mm con tomografía computarizada (TC) espiral (se medirá el diámetro mayor).
    Para medir las lesiones no podrán utilizarse la tomografía de emisión de positrones (PET) ni la ecografía.
    Función orgánica adecuada, que comprenda lo siguiente:
    -Reserva de médula ósea adecuada: recuento absoluto de neutrófilos (RAN) (segmentados y cayados) > o igual a 1,5 x 109/l, plaquetas >o igual a 100 x 109/l y hemoglobina > o igual a 9 g/dl.
    -Datos hepáticos: bilirrubina < o igual a 1,5 veces el límite superior de la normalidad (LSN), fosfatasa alcalina (FA), aspartato transaminasa (AST) y alanina transaminasa (ALT) < o igual a 3,0 x LSN (se pueden aceptar valores de FA, AST, y ALT < o igual a 5 x LSN si hay afectación tumoral del hígado).
    -Datos renales: aclaramiento de creatinina (ClCr) calculado > o igual a 45 ml/min según la fórmula estándar de Cockcroft y Gault
    Esperanza de vida estimada como mínimo en 12 semanas.
    Para mujeres: Deben ser estériles por métodos quirúrgicos, posmenopáusicas o seguir una pauta anticonceptiva médicamente aprobada (p. ej., dispositivo intrauterino [DIU], anticonceptivos orales o dispositivo de barrera) durante el período de tratamiento y 6 meses después del mismo; deben tener un resultado negativo en una prueba de embarazo en sangre o en orina realizada en los 7 días anteriores a la inclusión en el estudio, y no deben estar en período de lactancia.
    Para varones: Deben ser estériles por métodos quirúrgicos o utilizar un método anticonceptivo durante el período de tratamiento y los 6 meses posteriores al mismo.
    El paciente muestra una disposición y tiene una proximidad geográfica que permiten un seguimiento adecuado.
    El paciente o su representante legal deben firmar un documento de consentimiento informado.
    Los pacientes deben tener al menos 18 años de edad.
    E.4Principal exclusion criteria
    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.
    Han participado previamente en un estudio con pemetrexed.
    Tienen un diagnóstico histológico mixto de CPM y CPNM.
    Tienen un trastorno sistémico concomitante que, en opinión del investigador, podría comprometer su capacidad para cumplir el protocolo.
    Tienen una infección activa (≥ 38,5 ºC y/o reciben antibioterapia intravenosa).
    Padecen un trastorno cardíaco grave, como un infarto de miocardio en los seis meses previos, angina o cardiopatía, conforme a la definición de clase III o IV de la New York Heart Association
    Han recibido recientemente (en los 30 días anteriores al tratamiento del estudio) o de manera concurrente una vacuna contra la fiebre amarilla.
    Han padecido un proceso maligno previo distinto al CPM, 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 < o igual a 6) localizado serán elegibles aunque el diagnóstico se haya efectuado menos de 5 años antes.
    Las metástasis sintomáticas en el sistema nervioso central (SNC) y las metástasis asintomáticas en el SNC requieren terapia concurrente con corticosteroides. Las metástasis en el SNC tratadas y estables se permiten; el paciente debe estar estable después de la radioterapia durante > o igual a 2 semanas y sin corticosteroides durante > o igual a 1 semana.
    Presencia de acumulaciones clínicamente importantes de líquido en tercer espacio (por ejemplo, ascitis o derrame pleural) que no pueden ser controladas con drenaje u otros procedimientos antes de su inclusión en el estudio.
    Pérdida de peso significativa (> o igual a 10%) durante el período de 6 semanas anterior a la inclusión en el estudio.
    Administración concomitante de cualquier otro tratamiento antitumoral.
    Insuficiencia renal severa (aclaramiento de creatinina ≤ 45 ml/min).
    Tampoco podrán participar aquellos pacientes que presenten insuficiencia renal leve a moderada (aclaramiento de creatinina de 45 a 79 ml/min) y que no puedan dejar de tomar antiinflamatorios no esteroideos (AINEs) como ibuprofeno y ácido acetilsalicílico (> 1,3 g diarios) durante dos días antes, el mismo día y dos días después de la administración de pemetrexed (8 días en el caso de los preparados de larga acción, como el piroxicam). En aquellos pacientes con aclaramiento de creatinina >80 ml/min, se permitirá la administración de ibuprofeno o aspirina < 1,3 gr/d.
    Incapacidad o no deseo de tomar los suplementos de ácido fólico y vitamina B12.
    Incapacidad para tomar corticosteroides.
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de respuesta
    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 Yes
    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.8.3 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 concerned8
    E.8.5The trial involves multiple Member States No
    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
    Final del estudio: última visita del último paciente
    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 months0
    E.8.9.1In the Member State concerned 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 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 No
    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 state44
    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 Decision2007-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-01
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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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