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    The EU Clinical Trials Register currently displays   42567   clinical trials with a EudraCT protocol, of which   7008   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-014497-18
    Sponsor's Protocol Code Number:PM0259CA228B0
    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:2010-05-12
    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 number2009-014497-18
    A.3Full title of the trial
    Estudio en fase II que evalúa vinorelbina oral como agente único en pacientes con cáncer de mama con receptores hormonales positivos y metástasis óseas y que han recibido tratamiento hormonal previo. Phase II study evaluating oral vinorelbine as a single agent in patients with hormone receptor breast cancer with bone metastases previously treated by a hormone therapy
    A.4.1Sponsor's protocol code numberPM0259CA228B0
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 NAVELBINE 20 mg cápsulas blandas
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE IBERICA, S.A.
    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.3.4Pharmaceutical form Capsule, soft
    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 INNVINORELBINA TARTRATO
    D.3.9.3Other descriptive nameVINORELBINA TARTRATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 con metástasis óseas y que han recibido tratamiento hormonal previo.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la supervivencia libre de progresión (SLP) de vinorelbina oral como agente único en pacientes con cáncer de mama con receptores hormonales positivos y metástasis óseas y que han recibido tratamiento hormonal previo.
    E.2.2Secondary objectives of the trial
    •Valorar el perfil de seguridad del tratamiento
    •Evaluar otros parámetros de eficacia:
    -Beneficio clínico (RC + RP + EE &#61619; 24 semanas)
    -Duración del control de la enfermedad
    -Tiempo hasta el fracaso del tratamiento
    -Supervivencia global
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Mujeres:
    • De edad &#8805; 18 años;
    • Con adenocarcinoma de mama confirmado histológicamente;
    • Con afectación ósea documentada +/- otra enfermedad metastásica no visceral que no haya recibido tratamiento previo con quimioterapia;
    • Con enfermedad con receptores hormonales positivos determinada por &#8805; 10% de las células con resultado positivo a la tinción para receptores de estrógenos y/o progesterona por inmunohistoquímica en el tumor primario o en la localización metastásica;
    • Con HER2 negativo (valorado por 0-1+IHQ o 2+ IHQ con prueba FISH-) en el tumor primario o en la localización metastásica;
    • Con estadificación completa dentro de las 4 semanas anteriores al registro;
    • Las mujeres en edad fértil deberán utilizar un método anticonceptivo médicamente aceptado para evitar el embarazo durante los dos meses anteriores al inicio del tratamiento en estudio, durante el periodo del estudio y hasta tres meses después de la última dosis del tratamiento en estudio, de modo que quede reducido al mínimo el riesgo de embarazo;
    • Las mujeres en edad fértil deberán obtener un resultado negativo en el test de embarazo en suero en las 72 horas anteriores al inicio del tratamiento en estudio;
    • Las pacientes deberán haber recibido como mínimo un tratamiento hormonal previo para el cáncer de mama en cualquier fase de la enfermedad;
    • Se admiten pacientes que hayan recibido quimioterapia adyuvante o neoadyuvante si han sufrido recaída más de 6 meses después del término de la quimioterapia.
    • Las pacientes deberán estar en tratamiento con un bisfosfonato como mínimo desde un mes antes de entrar en el estudio;
    • Las pacientes pueden haber recibido radioterapia previa, pero deberá haber transcurrido un intervalo mínimo de 4 semanas;
    • Estado funcional de Karnofsky &#8805; 70%;
    • Expectativa de vida &#8805; 16 semanas;
    • Funciones renal, hepática y de la médula ósea adecuadas, demostradas por los siguientes parámetros:
    - Hemoglobina &#8805; 10 g/dl;
    - Recuento total de neutrófilos &#8805; 1,5 x 109/l;
    - Plaquetas &#8805; 100 x 109/l;
    - Bilirrubina total < LSN (LSN: Límite superior de normalidad);
    - SGOT/SGPT <o= 2,5 x LSN,
    - Fosfatasa alcalina < 5 x LSN
    - Aclaramiento de la creatinina > 50 ml/min; calculado mediante la fórmula de Cockroft y Gault.
    • Ausencia de cualquier situación psicológica, familiar, sociológica o geográfica que pueda dificultar el cumplimiento del protocolo en estudio y el programa de seguimiento; estas situaciones deberán valorarse con la paciente antes de su registro en el ensayo.
    • La paciente debe tener acceso al sistema sanitario público de acuerdo con la legislación local.
    • La paciente deberá otorgar el consentimiento informado por escrito (firmado y fechado personalmente) antes de realizar cualquier procedimiento relacionado con el estudio.
    E.4Principal exclusion criteria
    • Una mujer no es elegible para entrar en el estudio si:
    - es gestante o está en periodo de lactancia
    - presenta un test de embarazo positivo en el momento de la inclusión;
    • Pacientes con afectación metastásica visceral (que incluye como mínimo, de una de las siguientes: hepática, pulmonar, pleural, cardíaca, peritoneal, del SNC, del bazo y de las glándulas suprarrenales);
    • Pacientes con síntomas que indican afectación del SNC o metástasis leptomeníngeas;
    • Tratamiento hormonal concomitante para el cáncer de mama metastásico;
    • Síndrome de malabsorción o enfermedad que afecta notablemente a la función gastrointestinal o resección mayor del estómago o del intestino delgado proximal que afecte a la absorción de vinorelbina oral (Navelbine Oral);
    • Tratamiento previo con quimioterapia en el marco metastásico;
    • Pacientes previamente tratadas con vinorelbina en estadios iniciales;
    • Pacientes con disfagia o incapacidad para tragar las cápsulas;
    • Otras enfermedades graves o afecciones médicas:
    &#61656; Cardiopatía;
    &#61656; Diabetes inestable;
    &#61656; Hipercalcemia no controlada;
    &#61656; Infecciones activas clínicamente importantes;
    &#61656; Aloinjerto previo
    • Neuropatía periférica actual &#8805; grado 2 según los criterios NCI;
    • Participación en otro ensayo clínico con un fármaco en investigación en los 30 días anteriores al registro y/o durante el estudio.
    • Antecedentes de otro tumor maligno en los últimos cinco años excepto el carcinoma de las células basales de la piel o carcinoma in situ de útero.
    • Hipersensibilidad conocida a los alcaloides de la vinca.
    E.5 End points
    E.5.1Primary end point(s)
    • Determinar la supervivencia libre de progresión (SLP) de vinorelbina oral como agente único en pacientes con cáncer de mama con receptores hormonales positivos y metástasis óseas y que han recibido tratamiento hormonal previo.
    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 No
    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 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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Ensayo con vinorelbina oral como agente único
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    The end of the study period is defined as the time from 30 days after the last disease progression observed. Survival information will be collected approximately every 3 months until death.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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 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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    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)
    See protocol
    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 Decision2010-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
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