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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
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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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:2008-004136-20
    Sponsor's Protocol Code Number:2008/21
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-004136-20
    A.3Full title of the trial
    ETUDE PILOTE DE DEPISTAGE DES SUJETS DEFICITAIRES EN DIHYDROPYRIMIDINE DESHYDROGENASE. APPLICATION AU CANCER DU SEIN TRAITE PAR FLUOROPYRIMIDINE ORALE.
    A.3.2Name or abbreviated title of the trial where available
    DPD SEIN
    A.4.1Sponsor's protocol code number2008/21
    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 SponsorCENTRE ANTOINE LACASSAGNE
    B.1.3.4CountryFrance
    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 XELODA
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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
    Cancer du sein métastatique
    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
    Déterminer la sensibilité, la spécificité et les valeurs prédictives positives et négatives du rapport plasmatique UH2/U mesuré avant le début du traitement vis-à-vis de la survenue d’une toxicité grade 3-4 liée à un traitement par capécitabine (toxicité hématologique, diarrhée et syndrome main-pied) au premier et au deuxième cycle de traitement.
    E.2.2Secondary objectives of the trial
    1.Evaluer la faisabilité pratique d’un screening à grande échelle du rapport plasmatique UH2/U
    2.Confirmer la valeur du génotype germinal de la TS comme facteur prédictif de résistance à la capécitabine
    3. Analyser La tolérance au traitement.
    4. Etudier les polymorphismes des autres gènes potentiellement pertinents vis-à-vis de la capécitabine ainsi que le rapport plasmatique dihydrouracile/uracile (UH2/U) avant traitement.
    5. Déterminer la sensibilité, la spécificité et les valeurs prédictives positives et négatives du génotypage de la DPD vis-à-vis des toxicités de grade 3-4 à la capécitabine
    6. Evaluer la pharmacocinétique de la capécitabine et de ses métabolites afin de la mettre en relation avec le rapport UH2/U et le génotype de la DPD.
    7. Evaluer le coût total (transport des échantillons, coût de laboratoire) de ce screening pré-thérapeutique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patiente de sexe féminin âgée de plus de 18 ans,
    Patiente présentant un cancer du sein métastatique prouvé (preuve radiologique, scintigraphique ou histologique),
    Patiente débutant un traitement par capécitabine en monothérapie ou en association avec une thérapie ciblée anti-angiogénique (bévacizumab ou autre anti-angiogénique), quelques soient les lignes thérapeutiques antérieures.
    Patiente présentant une ou des cibles mesurables ou évaluables
    Signature du consentement éclairé
    Affiliation à un régime d’assurance sociale
    Patiente en âge de procréer sous traitement contraceptif efficace
    E.4Principal exclusion criteria
    Capécitabine co-administrée avec une chimiotérapie,
    Présence de métastase cérébrale non contrôlée,
    Durée de vie estimée de moins de 3 mois,
    Présence d’une maladie chronique non équilibrée,
    Présence d’une insuffisance cardiaque,
    Antécédent de cancer primitif antérieur autre que carcinome cutané baso-cellulaire,
    Présence d’une infection sévère non contrôlée,
    Présence d’une insuffisance veineuse périphérique,
    Présence d’une insuffisance respiratoire hypoxémiante
    Patiente présentant un désordre psychologique
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal sera l’analyse de la toxicité reliée au traitement par capécitabine évaluée au décours du premier cycle, deuxième cycle et dans les 21 jours suivant la fin du deuxième cycle selon les critères CTCAE (Common Terminology Criteria forAdverse Event Version 3). Le grade de chaque type de toxicité hématologique, diarrhée, vomissement et syndrome main-pied sera évalué au 1er cycle, 2ème cycle et dans les 21 jours suivant la fin du deuxième cycle. La survenue d’évènements indésirables graves sera documentée.
    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 No
    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) 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned3
    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 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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    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 Decision2008-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-01
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