Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-003164-35
    Sponsor's Protocol Code Number:PELICAN
    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:2010-03-15
    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 number2005-003164-35
    A.3Full title of the trial
    Estudio multinacional, aleatorizado y abierto, para comprobar el tratamiento con doxorrubicina liposomal pegilada o capecitabina como quimioterapia de primera línea par el cáncer de mama metastático
    A.3.2Name or abbreviated title of the trial where available
    PELICAN
    A.4.1Sponsor's protocol code numberPELICAN
    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 Sponsoressex pharma GmbH
    B.1.3.4CountryGermany
    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 Caelyx
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europa Essex Pharma
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCAELYX
    D.3.4Pharmaceutical form Concentrate 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 INNDoxorrubicina hidroclorhidro (pegilada liposomal)
    D.3.9.1CAS number 25316-40-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 RoleComparator
    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 Xeloda 150 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma (Schweiz) AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameXELODA
    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 INNcapecitabina
    D.3.9.1CAS number 154361-50-9
    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 Information not present in EudraCT
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Xeloda 500mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma (Schweiz) AG
    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 nameXELODA
    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 INNcapecitabina
    D.3.9.1CAS number 154361-50-9
    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.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 mama metastásico
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    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 primario del estudio es comparar el tiempo de progression (TTP) en pacientes con cáncer de mama metastásico tratadas con doxorrubcina liposomal pegilada (50 mg/m2 cada 28 días) o con capecitabina (1250 mg/m2 BID x 14 días cada 21 días).
    E.2.2Secondary objectives of the trial
    - Comparar las tasas de respuesta global (RC+RP) entre los dos grupos de tratamiento
    - Comparar la supervivencia global entre los dos grupos de tratamiento
    - Evaluar los efectos de la doxorrubicina liposomal pegilada y la capecitabina sobre la calidad de vida determinada mediante los cuestionarios EORTC QLQ-C30 y SSQ
    - Comparar los tiempos hasta el fracaso del tratamiento entre los dos grupos de tratamiento
    -Evaluar las cargas del tratamiento relacionadas con la edad y la comorbilidad en todas las pacientes mediante métodos de evaluación geriátrica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Mujeres
    - Enfermedad metastásica de cáncer de mama confirmado citológica o histológicamente
    - Edad igual o superior a 18 años
    - Enfermedad evaluable (al menos una lesión medible unidimensionalmente conforme a los criterios RECIST en al menos una localización que no haya sido irradiada); sin embargo, no se excluye a las pacientes que sólo presenten enfermedad no medible / evaluable. Tampoco se escluye a las pacientes que sólo presenten metástasis óseas
    - Estado funcional del ECOG 0-2
    - las pacientes deben tener una esperanza de vida suficiente como para recibir tratamiento de quimioterapia
    - Voluntad y capacidad para completar los cuestionarios del estudio
    - Funcion renal adecuada, evidenciada por una creatinina sérica =<1.5mg/dl. No obstante, si la creatinina sérica es > 1.5mg/dl pero=< 1.8 mg/dl, entonces el aclaramiento de creatinina debe ser=>45 ml/dl pero =< 1.8 mg/dl, entonces el aclaramiento de creatinina debe ser =>45ml/min.
    - Función de médula ósea adecuada, evidenciada por un recuento de leucocitos > 3.5 x 10^9/L, una hemoglobina => 9.0g/dl y un recuento de plaquetas =>100 x10^9/L
    - Función hepática adecuada, evidenciada por una bilirrubina =<1.5 veces el límite superior de la normalidad (LSN), salvo a que se deben a metastasis hepáticas
    - los valores de Na y K de las pacientes deben estar dentro de los limites normales
    - Estado clínico (comorbilidad) que permita un tratamiento en terapia monoterapia o pacientes que hayan expresado su voluntad de ser tratadas con monoterapia
    - Tratamiento con trastuzumab no indicado
    - Firma del documento de consentimiento informado indicando que la paciente entiende el propósito y los procedimientos del estudio y que desea participar en el estudio
    E.4Principal exclusion criteria
    -Antecedentes de tratamiento previo para la enfermedad metastásica [ Nota: las pacientes pueden haber recibido hormonoterapia o quimioterapia en el ámbito adyuvante; las pacientes pueden haber recibido hormonoterapia para la enfermedad metastásica, las pacientes podran haber recibido radioterapia local para el alivio sintomático]
    - Receptores estrogénicos / de progesterona positivos con indicación de tratamiento endocrino. Sin embargo, no se excluye a las pacientes que hayan presentado progresión durante la hormonoterapia
    - Hipersensibilidad conocida al clorhidrato de doxorrubicina o a cualquiera de sus excipientes o hipersensiblidad conocida a la capecitabina o al fluorouracilo o a culaquiera de sus excipientes
    - Deficiencia de DPD (dihidropirimidina) conocida
    - Tratameinto concomitante con sorivudina o sus análogos relacionados químicamente, como la brivudina
    - Tratamiento concomitante (excepto bifosfanatos) por enfermedad metastásica, incluidas la hormonoterapia y la radioterapia (salvo radiación local para el alivio sintomático). Tampoco se permiten el trastuzumab ni los agentes biológicos
    - Antecedentes con tratamiento con capecitabina
    - Antecedentes de tratamiento con antraciclinas en el ámbito adyuvante con dosis acumulada de antraciclinas que superen 360 mg/m2 de doxorrubicina (o equivalente, p.ej., 600 mg/m2 de epirrubicina)
    - Enfermedad resistente a las antraciclinas. La resistencia a las antraciclinas se define como el desarrollo de enfermedad metastásica o recidiva local durante el tratamineto adjuvante con antraciclinas, o la aparición de recidiva menos en de 12 meses después de terminar el tratamiento con antraciclinas
    - Fuerte presión de remisión que precise poliquimioterapia con excepcion de las pacientes no adecuadas para un tratamiento con poliquimioterapia o que no acepten la poliquimioterapia
    - Signos de proceso maligno primario o metastásico que afecte al sistema nervioso central, a menos que haya sido tratado previamente y haya permanecido asintomáticamente durante 3 meses o más
    - Las pacientes con tumores con una sobreexpresión del Her-2/neu quedarán excluidas con la más reciente evaluación de los relevantes resultados (inmunologicamente Her2neu3 + positivo o Her2neu-2 + positivo y "Fish" positivo.
    - Función hepática reducida (evidenciada por una bilirrubina por encima de 1.5 veces el límite superior de la normalidad (LSN)(salvo pacientes con metástasis de hígado donde la bilirrubina no debe ser de más de 5 veces el LSN), fosfatasa alcalina por encima de 3 veces el LSN (salvo que esté relacionada con la metastasis del hígado en cuyo caso será de =<5 x LSN)
    - Disnea al esfuerzo (salvo que ésta sea causada por metástasis pulmonar o efusión pleural)
    - Antecedentes de cardiopatía, de clase => II de la New York Heart Association o signos clínicos de insuficiencia cardiaca congestiva o infarto de miocardio hace menos de seis meses o FEVI por debajo del 50%
    - Mujeres potencialmente fértiles que no utilicen un método anticonceptivo adecuado [se considera adecuado, p. el dispositivo intra-uterino (DIU) durante el periodo de estudio y los seis meses posteriores a la última administración del fármaco del estudio. No se permite ningún método basado en la contracepción hormonal
    - Embarazo o lactancia (observado en una prueba de embarazo)
    - Dudas sobre la capacidad o la voluntad de la sujeto para cooperar
    - Participación de la sujeto en un estudio clínico en los últimos 30 días
    - Participación de la sujeto en el mismo estudio clínico en una fecha anterior
    - Participación concomitante en otro estudio aparte del que aquí se describe
    - Abuso de drogas, alcohol o medicamentos
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo primario es el tiempo de progresión (TTP), el cual se define en la sección 9.2, será medido en meses. Debido al diseño como primera línea del estudio en CMM, la supervivencia global ha sido solamente elegida como objetivo secundario.
    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 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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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 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
    El final del estudio se define como el cierre de la base de datos para la totalidad del estudio. Esta definicion se aplica en lugar de la ultima visita del último paciente para pesentar el resumen del informe del estudio completo correspondiente a todo el estudio dentro de los plazos de tiempo establecidos por los requisitos de regulación. La aplicación de esta definición ayuda a evitar la necesidad de preparar informes para cada país.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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 No
    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 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 2010-03-15. Yes
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 194
    F.4.2.2In the whole clinical trial 210
    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)
    Ver protocolo sección 9.1.4.
    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 Decision2006-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-28
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 11:48:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA