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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2005-005535-10
    Sponsor's Protocol Code Number:H3E-MC-JMHX
    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:2006-02-02
    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 number2005-005535-10
    A.3Full title of the trial
    Estudio fase 2 de pemetrexed para el tratamiento de pacientes con tumores sólidos y acumulación líquida estable en el tercer espacio


    A Phase 2 study of ALIMTA in solid tumor patients with stable third-space fluid
    A.4.1Sponsor's protocol code numberH3E-MC-JMHX
    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 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 cáncer pulmonar no microcítico avanzado y/o metastásico recidivado (estadio III o IV) 24 pacientes, que muestren acumulaciones de líquido en el tercer espacio.
    Pacientes con cáncer ovárico avanzado, resistente al platino, que muestren acumulaciones de líquido en el tercer espacio.24 pacientes
    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
    El objetivo principal de este estudio de fase 2 consiste en evaluar la seguridad y la farmacocinética de pemetrexed en pacientes con líquido en el tercer espacio (derrame pleural o ascitis).
    E.2.2Secondary objectives of the trial
    •Identificar los aumentos en la toxicidad de pemetrexed en pacientes con líquido en el tercer espacio conforme a la escala CTC (criterios comunes de toxicidad), en su versión 2.0 (NCI 1998).
    •Evaluar la relevancia clínica de cualquier cambio en la farmacocinética de pemetrexed en pacientes con líquido en el tercer espacio.
    •Aportar recomendaciones para dosificar pemetrexed en los pacientes con líquido en el tercer espacio.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    [[1]Diagnóstico histológico o citológico de CPNM localmente avanzado o metastásico (estadio III o IV en el momento de la inclusión) o de cáncer ovárico epitelial recidivante, resistente al platino, no sensible a tratamiento curativo.
    Los pacientes con CPNM deberán haber recibido tratamiento previo con una quimioterapia que contenga algún compuesto de platino para tratar su enfermedad localmente avanzada o metastásica. Asimismo, se podrá elegir a los pacientes con CPNM si han recibido de forma neoadyuvante o adyuvante un régimen de quimioterapia basado en platino pero deberán, además, haber recibido otro régimen adicional de quimioterapia tras la recidiva.
    Las pacientes con cáncer ovárico han de mostrar enfermedad resistente al platino, que se define como una neoplasia que recidive en menos de 6 meses después del tratamiento, de primera o segunda línea, basado en platino o progresión del tumor durante el tratamiento de primera o segunda línea basado en platino.
    Las pacientes con cáncer ovárico reclutadas en este estudio para el tratamiento de tercera línea no deberán haber mostrado una enfermedad resistente al platino después del tratamiento de primera línea. Las pacientes reclutadas en este estudio para el tratamiento de tercera línea deberán haber presentado una recidiva de la enfermedad en menos de 6 meses después del tratamiento de segunda línea basado en el platino o una enfermedad progresiva (EP) como respuesta máxima. Para las pacientes, cuyo tratamiento del estudio represente la tercera línea, la respuesta máxima al tratamiento de primera línea basado en el platino debería haber sido una respuesta completa (RC), una respuesta parcial (RP), una enfermedad estable (EE) o una respuesta no evaluable debido a una cirugía citorreductora óptima.
    [2]Presencia de líquido clínicamente detectable (mediante exploración física) y estable (sin necesidad de drenaje durante al menos 3 semanas después del 1er ciclo) en tercer espacio (ascitis o derrame pleural).
    [3]Para el reclutamiento de este estudio no se exigirán lesiones medibles.
    [4]El tratamiento antineoplásico previo (con excepción de la radioterapia) se habrá completado como mínimo 3 semanas antes del reclutamiento y el paciente deberá haberse recuperado de los efectos tóxicos agudos de la quimioterapia.
    [5]Se permitirá la radioterapia previa sobre <25% de la médula ósea. No se autorizará la radioterapia previa de toda la pelvis. La radioterapia previa deberá haberse finalizado por lo menos 2 semanas antes del reclutamiento del estudio y el paciente se encontrará recuperado de los efectos tóxicos agudos de este tratamiento antes del reclutamiento para el estudio.
    [6]Categoría funcional ECOG (Eastern Cooperative Oncology Group) de 0 a 1 (Oken y cols., 1982; véase apéndice al protocolo JMHX.3.).
    [7]Esperanza mínima de vida de 8 semanas.
    [8]Cumplimiento terapéutico y proximidad geográfica que permitan un seguimiento idóneo del paciente.
    [9]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 x veces el límite superior de la normalidad (LSN), fosfatasa alcalina (F. Alc.), aspartato transaminasa (AST) y alanito transaminasa (ALT) 3  LSN (se admitirán valores de F. Alc., AST y ALT 5 x LSN si el hígado presenta afectación tumoral).
    •Riñón: CrCl calculado >45 mL/min según la fórmula convencional de Cockcroft y Gault (Cockcroft y Gault, 1976; véase apéndice al protocolo JMHX.4). Las decisiones de reclutamiento y dosificación basadas en el aclaramiento de creatinina se tomarán en función de los valores del laboratorio local. Se reclutará a los pacientes sobre la base del valor del laboratorio local. Se utilizará el mismo laboratorio local a lo largo del estudio para tomar las decisiones posológicas.
    [10]Firma del documento de consentimiento informado.
    [11]Varones o mujeres con una edad mínima de 18 años.
    [12]Los pacientes de ambos sexos, en edad fértil, deberán seguir un método anticonceptivo autorizado, si procede (por ejemplo, dispositivo intrauterino, anticonceptivos orales o dispositivos de barrera), durante y hasta 3 meses después del tratamiento. Se exigirá a las mujeres en edad fértil un resultado negativo de una prueba de embarazo en el suero realizada en los 7 días anteriores al reclutamiento del estudio.
    E.4Principal exclusion criteria
    [1] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    [2] Active infection that, in the opinion of the investigator, would compromise the patient’s ability to tolerate therapy.
    [3] Pregnancy.
    [4] Breast-feeding.
    [5] Serious concomitant systemic disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator.
    [6] Second primary malignancy that is clinically detectable at the time of consideration for study enrollment (with the exception of in situ carcinoma of the cervix, adequately treated basal cell carcinoma, and early stage prostate cancer with Gleason grade < 6).
    [7] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
    [8] Brain metastases. patients who are symptomatic for brain metastases must have a pretreatment computed tomography or magnetic resonance imaging (CT or MRI) of the brain. A patient with documented brain metastases at the time of study entry will be excluded from entering the study. Patients with prior brain metastases may be considered if they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic.
    [9] Significant weight loss (>10% of body weight) over the 6 weeks before study entry.
    [10] Inability or unwillingness to take folic acid, vitamin B12 supplementation, or a corticosteroid.
    [11] Have previously completed or withdrawn from this study or any other study investigating pemetrexed.
    E.5 End points
    E.5.1Primary end point(s)
    Los parámetros farmacocinéticos que se determinarán en función de los datos de la concentración plasmática frente al tiempo son: Cmáx, t1/2, AUC desde el tiempo 0 hasta el infinito (AUC[0-]), Vss y aclaramiento plasmático total (CLP).
    En el estudio se han incorporado dos cruces independientes, de una sola secuencia, para investigar los posibles cambios en la farmacocinética de pemetrexed entre pacientes con derrame pleural o ascitis..
    En este ensayo se reclutarán a unos 48 pacientes, repartidos en 4 grupos de 12 según el tipo de enfermedad y el drenaje, o no, del líquido del tercer espacio antes del segundo ciclo de tratamiento (véase sección 3.1). En total, se drenará el líquido del tercer espacio de 12 pacientes con CPNM y de otros 12 con cáncer ovárico a los 21 días de la administración de pemetrexed en el primer ciclo y se procederá al análisis farmacocinético. El número de 12 pacientes da una probabilidad mínima del 90% para detectar un cambio del 30% en el CL o en el Vss de pemetrexed con un valor de significación del 5%. Este cálculo se basa en un coeficiente de variación (CV) intraindividual máximo del 20% de los parámetros farmacocinéticos examinados.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    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.8.5The 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
    Ultima visita (aproximadamente 30 dias despues de la discontinuacion) del ultimo paciente del ensayo
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-02-02. Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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 Decision2006-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-11
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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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