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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2012-000597-38
    Sponsor's Protocol Code Number:FESGEN.DOC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-05-10
    Trial 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 number2012-000597-38
    A.3Full title of the trial
    Ensayo clínico FESGEN.DOC: Evaluación de la variabilidad interindividual en farmacocinética, eficacia y seguridad de Docetaxel en el tratamiento neoadyuvante de cáncer de mama. Estudio farmacocinético/farmacogenómico/farmacodinámico (PK/PG/PD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ensayo clínico FESGEN.DOC: Estudio para la evaluación de los factores demográficos, bioquímicos, genéticos y clínicos implicados en la diferente eficacia y seguridad observada en el tratamiento con Docetaxel en pacientes con cáncer de mama tratadas con quimiterapia antes de la intervención quirúrgica.
    A.3.2Name or abbreviated title of the trial where available
    FESGEN.DOC
    A.4.1Sponsor's protocol code numberFESGEN.DOC
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstituto Catalán de Oncología
    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 supportMinisterio de Sanidad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Catalán de Oncología
    B.5.2Functional name of contact pointOficina de apoyo a investigación
    B.5.3 Address:
    B.5.3.1Street AddressAv Gran Via
    B.5.3.2Town/ cityL'Hospitalet de Llobregat
    B.5.3.3Post code08908
    B.5.3.4CountrySpain
    B.5.4Telephone number34932607749
    B.5.5Fax number34932607466
    B.5.6E-mailosr@iconcologia.net
    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.2.1.2Country 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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNDOCETAXEL
    D.3.9.1CAS number 148408-66-6
    D.3.9.3Other descriptive nameDOCETAXEL TRIHYDRATE
    D.3.9.4EV Substance CodeSUB21602
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 HER-2 negativo en tratamiento con quimioterapia previa a la cirugía.
    E.1.1.1Medical condition in easily understood language
    Pacientes diagnósticadas de cáncer de mama HER2 negativo que sean tratadas con quimioterapia antes de la escisión quirúrgica.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    ? Identificar los factores demográficos, bioquímicos, genéticos y clínicos implicados en la
    variabilidad interindividual de la farmacocinética o farmacodinámica de docetaxel.
    - Criterio de valoración principal: Correlacionar los parámetros cinéticos de docetaxel (Área bajo la curva, AUC) con las variantes genéticas (polimorfimos de un solo nucleótido).
    E.2.2Secondary objectives of the trial
    ? Correlacionar los parámetros cinéticos de docetaxel y los polimorfismos genéticos con la
    eficacia y la toxicidad del tratamiento en pacientes con cáncer de mama.
    Criterios de valoración secundaria:
    -Correlación de AUC y SNPs con la respuesta clínica: Porcentaje de reducción de tamaño tumoral (exploración física y pruebas de imagen)
    - Correlación de AUC y SNPs con la presencia y gravedad de toxicidad relacionada con Docetaxel.
    ? Conocer la tolerancia y seguridad del esquema de Docetaxel secuencial con
    Adriamicina+Ciclofosfamida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Firma del documento de consentimiento informado
    2) Pacientes ? 18 años.
    3) Diagnóstico histológico de carcinoma infiltrante de mama localizado con lesión primaria > 2 cm de diámetro mayor (medido por mamografía y RMN). Se permite cualquier estado ganglionar siempre que se trate de un tumor operable de inicio. Se permite multicentricidad.
    4) HER-2 negativo (Inmunohistoquímica ? o + sobre +++; FISH/CISH (-); el resultado HER-2 ++/+++ necesita confirmación mediante FISH/CISH)
    5) Enfermedad medible con una lesión primaria > 2 cm según los criterios WHO (RMN, mamografía
    o ecografía).
    6) ECOG 0-1.
    7) Adecuada función hematológica, renal y hepática, definida por los siguientes resultados de laboratorio:
    a) Recuento de granulocitos > 1.5 x 109/L
    b) Recuento de plaquetas > 100 x 109/L
    c) Hemoglobina > 10 g/dL
    d) Creatinina sérica > 1.5 veces el LSN o aclaramiento de creatinina calculado > 50ml/min
    e) Bilirrubina sérica < 1.25 veces el LSN
    f) AST/ALAT <1.5 veces el LSN
    8) Las mujeres fértiles deben utilizar un método anticonceptivo adecuado, no hormonal y
    continuar su uso durante todo el estudio y hasta 6 meses posteriores.
    9) En mujeres potencialmente fértiles, una prueba de embarazo negativa dentro de los 7 días previos a la inclusión en el estudio.
    10) Esperanza de vida superior a 6 meses.
    E.4Principal exclusion criteria
    1) Cáncer de mama metastásico o inoperable (incluyendo carcinoma inflamatorio).
    2) Cáncer de mama localizado con lesión primaria < 2 cm. En caso de multicentricidad, no se admite entrada en el estudio si ninguna lesión supera este tamaño.
    3) Tratamiento previo o concomitante de cualquier tipo para el cáncer de mama: agentes
    hormonales, fármacos citotóxicos convencionales, radioterapia, fármacos dirigidos,
    bifosfonatos, anticuerpos monoclonales o cirugía. La anticoncepción hormonal debe
    suspenderse al iniciar el tratamiento de quimioterapia.
    4) Cáncer de mama HER-2 positivo (sobrexpresión en inmunohistoquímica de HER-2 3+ o 2+ con FISH/CISH positivo).
    5) Pacientes varones.
    6) Embarazo o lactancia.
    7) Neoplasia maligna activa en cualquier otra localización, excepto cáncer cutáneo no
    melanomatoso o tumores de diagnóstico > 5 años antes de la inclusión en el estudio sin indicios de recidiva en el momento actual.
    8) Neuropatía periférica de grado ³ 2.
    9) Alergia demostrada a docetaxel, adriamicina o ciclofosfamida.
    10) Alteración hepática severa
    11) Recuento de neutrófilos inferior a 1.500 células/mm3.
    12) Tratamiento concomitante durante la quimioterapia con fenitoína, carbamazepina, rifampicina, fenobarbital, hierba de San Juan, ketoconazol o fluoxetina.
    E.5 End points
    E.5.1Primary end point(s)
    ? Perfil farmacocinético de Docetaxel que se estudiará mediante el cálculo del área de las curvas de concentración plasmática versus el tiempo (AUC) obtenido entre las 0-24 horas de la
    administración del fármaco.
    ? Presencia de polimorfimos de un solo nucleótido (SNP) en genes de enzimas
    metabolizadores y proteínas transportadoras implicados en la farmacocinética de docetaxel.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Se determinarán dos AUCs: en el primer ciclo de tratamiento de docetaxel y en el cuarto.
    Para el análisis de los polimorfismos genéticos se extraerá una muestra plasmática antes del inicio de tratamiento con docetaxel.
    E.5.2Secondary end point(s)
    ? Tasa de respuesta: Porcentaje de reducción de tamaño tumoral (después del tratamiento
    con docetaxel y después de finalizar todo el tratamiento de neoadyuvancia)
    ? Presencia y gravedad de toxicidades y efectos adversos relacionados con el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    La evaluación de la eficacia se realizará mediante pruebas de imagen al inicio y el final de tratamiento con docetaxel.
    La toxicidad de docetaxel se evaluará en cada ciclo de tratamiento.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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 estudio finalizará al concluir todos los procedimientos relacionados con el mismo, incluidos reclutamiento de pacientes, seguimiento y determinaciones de laboratorio asociadas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 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.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state100
    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 seguimiento habitual para pacientes en esta situación clínica
    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 Decision2012-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
    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 Apr 28 05:20:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA