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    Summary
    EudraCT Number:2007-001428-11
    Sponsor's Protocol Code Number:SOLTI 0702
    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:2007-05-24
    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 number2007-001428-11
    A.3Full title of the trial
    Ensayo clínico multicéntrico, abierto, de Fase II con doxorubicina liposomal pegilada (Caelyx®) como tratamiento Primario en pacientes con cáncer de mama y antecedentes de Cardiopatía o con Edad superior a 65 años (CAPRICE).
    A.3.2Name or abbreviated title of the trial where available
    CAPRICE
    A.4.1Sponsor's protocol code numberSOLTI 0702
    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 SponsorSOLTI
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 holderSP Europe
    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.3.4Pharmaceutical 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 INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.1CAS number 25316409
    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 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 de mama primario invasivo histológicamente confirmado.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006190
    E.1.2Term Breast cancer invasive NOS
    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 frecuencia de respuesta patológica completa (pCR) en el momento de la cirugía en pacientes con riesgo de desarrollar cardiotoxicidad por antraciclinas y que iniciaron un esquema de quimioterapia primaria con Doxorubicina Liposomal Pegilada y Ciclofosfamida seguido de Paclitaxel.
    E.2.2Secondary objectives of the trial
    •Estimar la frecuencia de respuesta clínica (Completa + Parcial) evaluada radiológicamente, tras Doxorubicina Liposomal Pegilada y Ciclofosfamida y antes y después de Paclitaxel.
    •Estimar la frecuencia de cirugía conservadora de la mama.
    •Estimar la frecuencia de pacientes sin afectación de ganglios axilares (pN0) en el momento de la cirugía.
    •Estimar la función ventricular izquierda, mediante la fracción de eyección (ecocardiografía o MUGA), un cuestionario de síntomas y signos cardíacos, y la incidencia de acontecimientos adversos cardíacos durante el tratamiento y hasta 5 años después de la cirugía.
    •Evaluar la seguridad del tratamiento médico administrado.
    •Evaluar la supervivencia libre de recaída a los 5 años de la cirugía.
    •Evaluar la Supervivencia Global a los 5 años de la inclusión en el estudio.
    •Evaluar factores predictivos de pCR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Cáncer de mama invasivo histológicamente confirmado.
    •Tumor > 2 cm.
    •Receptores de estrógenos negativos, o débilmente positivos (menos de un 50% de las células) y analizados por IHC.
    •Al menos una de las siguientes situaciones de riesgo de desarrollar cardiomiopatía por antraciclinas:
    1.Edad > 65 años
    2.Enfermedad cardiaca clínicamente controlada en el momento de la inclusión en el estudio, considerando cualquiera de las siguientes:
    a.Arritmia que requiere medicación.
    b.Enfermedad Valvular.
    c.Enfermedad coronaria (último ataque cardiaco o angor > de 6 meses antes de la inclusión).
    d.Hipertrofia ventricular izquierda.
    3.Hipertensión arterial que requiera tratamiento farmacológico
    4.FEVI < 55%.
    5.Irradiación previa del mediastino.
    6.Tratamiento previo con antraciclinas.
    •Las pacientes deben tener capacidad de seguir el protocolo del estudio.
    •En pacientes fértiles, debe realizarse test de embarazo β-hCG (gonadotropina coriónica humana) en la semana previa al inicio del estudio y su resultado debe ser negativo.
    •Las pacientes fértiles deben utilizar un método anticonceptivo permitido (Ej.: Barrera con espermicidas, abstinencia absoluta). No se permite el uso de anticonceptivos hormonales.
    •Dar su consentimiento informado por escrito.
    E.4Principal exclusion criteria
    •Insuficiencia cardiaca severa (Grado III o IV de la clasificación NYHA) (Anexo 5).
    •Intervalo de menos de 6 meses desde el último ataque por isquemia cardiaca.
    •Carcinoma lobulillar invasivo, Carcinoma infiltrante de grado I, carcinoma coloide.
    •Enfermedad metastásica.
    •Índice Karnofsky < 70.
    •FEVI < 45%
    •Leucocitos < 2,5 x 109/l, neutrófilos < 1,5 x 109/l, o plaquetas < 100 x 109/l.
    •Tener conocimiento de que el tumor sobreexprese o amplifique HER2.
    •AST, ALT o Fosfatasas alcalinas > 5 veces por encima de los valores de la normalidad.
    •Bilirubina 1,5 veces por encima de los valores de la normalidad.
    •Insuficiencia renal grave (aclaramiento de creatinina < 30 ml/min.).
    •Infección grave y activa no controlada.
    •Dosis acumulada de antraciclinas previas mayor de 300 mg/m2 para el caso de doxorubicina o de 360 mg/m2 para el caso de epirubicina.
    •Hipersensibilidad conocida a los medicamentos del ensayo.
    •Embarazo o lactancia.
    •Tratamiento actual con otro producto de investigación.
    •Demencia, alteración del estado mental o anomalías psíquicas que puedan perturbar la decisión del otorgar el consentimiento.
    E.5 End points
    E.5.1Primary end point(s)
    •Respuesta patológica completa (pCR). Se considerará que hay pCR ante la ausencia de cáncer invasivo en la pieza quirúrgica de la mama operada. También se considerará que hay pCR si sólo se evidencia carcinoma in situ. No se valorará patología de ganglios axilares para la definición de la pCR.
    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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    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 months6
    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 months6
    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 state61
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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)
    El tratamiento posterior a la participación en el ensayo será el tratamiento habitual para estos pacientes.
    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 Decision2007-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
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