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    The EU Clinical Trials Register currently displays   38927   clinical trials with a EudraCT protocol, of which   6396   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-004097-41
    Sponsor's Protocol Code Number:2008.512/13
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-07-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-004097-41
    A.3Full title of the trial
    « OCTO : Quantification de l’impact des variations d’Observance d’une ChimioThérapie Orale par l’utilisation de piluliers électroniques et modélisation des marqueurs de toxicités»
    A.3.2Name or abbreviated title of the trial where available
    OCTO
    A.4.1Sponsor's protocol code number2008.512/13
    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 SponsorHospices Civils de Lyon
    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 holderLaboratoires ROCHE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameCAPECITABINE
    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
    Breast cancer female
    Colorectal cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    o Estimer l’observance chez des patients traités par capecitabine (Xeloda®), une chimiothérapie orale, pour un cancer colorectal ou mammaire suivant deux techniques complémentaires :
    • par système électronique individuel enregistrant l’heure et la date à laquelle le patient prélève ses pilules avant leur ingestion supposée
    • des prélèvements pharmacocinétiques couplés à une modélisation pharmacocinétique de population du Xeloda® et des métabolites afin d’imputer l’observance sur les dernières prises précédant le prélèvement.
    E.2.2Secondary objectives of the trial
    o Quantifier les impacts des variations d’observance et l’évolution au cours du temps par modélisation mathématique des différents marqueurs de toxicité ainsi que leurs interactions respectives.
    o Compléter par une approche sociologique permettant, à partir d’éléments qualitatifs, de mettre en évidence des profils-types de patients par rapport à la problématique de l’observance (des tendances).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Age supérieur ou égal à 18 ans
    o Patients atteints :
    *d’un cancer colorectal traité par capecitabine (Xeloda®) en monothérapie dans les indications suivantes :
    - traitement adjuvant après résection
    - stade métastatique
    *ou, d’un cancer mammaire localement avancé ou métastatique traitées par capecitabine (Xeloda®) en monothérapie
    o PS ≤ 2
    o Bilans hématologique et hépatique satisfaisants :
    PNN > ou égal 1.5×109/L, plaquettes > ou égal 100×109/L,
    créatinine < ou égal 110 µmol/L,
    bilirubine totale < ou égal 2 × LSN, ASAT (SGOT) et ALAT
    (SGPT) < ou égal 2,5 × LSN, Phosphatases alcalines < ou égal 5 × LSN
    o Etat compatible avec la réalisation d’une chimiothérapie orale
    o Consentement éclairé, daté et signé
    o Affiliation à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    o Traitement antérieur par capecitabine (Xeloda®) ou 5-Fluorouracile (5-FU) ou autre fluoropyrimidine préalablement à l’étude
    o Hypersensibilité à la capécitabine, à l'un des excipients ou au fluoro-uracile.
    o Prise en charge en hospitalisation à domicile.
    o Leucopénie, neutropénie ou thrombocytopénie sévère.
    o Insuffisance rénale sévère (clairance de la créatinine calculée inférieure à 30 ml/min).
    o Insuffisance hépatique sévère (Bilirubine >2 LSN, ou ASAT, ALAT >2.5 LSN métastases ou pas)
    o Insuffisance cardiaque grave (Infarctus moins de 6 mois)
    o Traitement par la sorivudine, ou ses analogues chimiquement apparentés, tels que la brivudine.
    o Femme enceinte ou allaitante
    o Personne sous tutelle, sous curatelle, privée de liberté
    o Personne dont l’éloignement géographique ou l’état psychologique ne permet d’envisager le suivi
    o Déficit connu en DPD.
    o Métastases cérébrales ou méningées symptomatiques
    o Patient en période d’activité génitale ne prenant pas de mesures contraceptives adéquates.
    o Maladie sévère, troubles psychiatrique grave
    E.5 End points
    E.5.1Primary end point(s)
    a) MESURE DE L’OBSERVANCE ET EVALUATION DU PROFIL TYPE DU PATIENT :

    Etape I
    o Comptage des pilules restantes dans les blisters
    o Modélisation PK pour estimer l’observance des dernières prises
    o Auto-questionnaire à l’inclusion et entretien semi-directif dans les 2 mois suivant la fin du cycle 6 de traitement.
    Etape II
    o Comptage des pilules restantes dans les piluliers à bouchon électronique
    o Analyse des temps d’ouverture des piluliers à bouchon électronique pour estimer l’observance sur la totalité du cycle.
    o Modélisation PK pour estimer l’observance sur les dernières prises
    Auto-questionnaire à l’inclusion et entretien semi-directif dans les 2 mois suivant la fin du cycle 6 de traitement.


    b) CRITÈRES D’ÉVALUATION clinique :

    Lors de chaque visite du patient correspondant à la fin d’un cycle de traitement, soit toutes les 3 semaines
    o Un personnel de l’équipe clinique vérifiera avec le patient que les effets secondaires ont bien été notés dans son Carnet de Liaison, ce pour chaque semaine du cycle de traitement. Il (ou elle) complètera éventuellement le Carnet de Liaison sur les indications du patient
    o Le Carnet de Liaison sera photocopié
    o Les toxicités notées dans le Carnet de Liaison seront quottées suivant le système de classification du National Cancer Institute of Canada Common Toxicity Criteria (NCIC CTC) pour chaque semaine du cycle.
    o Evaluation tumorale
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    sociologique (observance)
    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) 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 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months7
    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 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.1.3Elderly (>=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 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 2008-07-08. 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 state30
    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 Decision2008-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
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