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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2008-003930-19
    Sponsor's Protocol Code Number:xxxxxxxxxxxxxxxxxxxxxxxxxxx
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-03-12
    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 number2008-003930-19
    A.3Full title of the trial
    Essai multicentrique randomisé de phase II comparant le Taxotère® en monothérapie à l’association Taxotère® plus curcumine en première ou deuxième ligne de traitement des cancers du sein inopérables, en rechute ou métastatiques, Her2 négatifs
    A.3.2Name or abbreviated title of the trial where available
    CURRYTAX
    A.4.1Sponsor's protocol code numberxxxxxxxxxxxxxxxxxxxxxxxxxxx
    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 JEAN PERRIN
    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 TAXOTERE
    D.2.1.1.2Name of the Marketing Authorisation holderAVENTIS PHARMA
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    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.3.9.1CAS number 148408-66-6
    D.3.9.3Other descriptive nameDOCETAXEL TRIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    cancers du sein inopérables, en rechute ou métastatiques, Her2 négatifs
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer les taux de réponses objectives (RC + RP) de cancers du sein inopérables, en rechute locale ou métastatiques, Her2 négatifs, en première ligne ou deuxième ligne de traitement par Taxotère® seul ou par l'association Taxotère® + curcumine.
    E.2.2Secondary objectives of the trial
    - Evaluer le bénéfice clinique : réponses objectives (RC + RP) et stabilisations (ST)
    - Evaluer la survie globale et le temps jusqu’à progression dans les 2 bras de traitement.
    - Evaluer la tolérance et la compliance au traitement per os (curcumine) des patients atteints d’un cancer du sein en rechute locale ou métastatique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Homme ou femme ayant âge > 18 ans.
    - Performance status ≤ 2 selon les critères de l’OMS.
    - Espérance de vie > 3 mois.
    - Her2 négatif.
    - Indication de traitement par Taxotère® en première ligne ou deuxième ligne après une chimiothérapie cytotoxique ayant comporté une anthracycline et un agent alkylant, donné en adjuvant ou néo-adjuvant, ou en première ligne métastatique. En cas de traitement en phase métastatique, le traitement adjuvant ou néo-adjuvant sera considéré comme une seule ligne et devra être terminé depuis au moins 12 mois.
    - Une hormonothérapie seule n’est pas décomptée dans le calcul des lignes antérieures.
    - Bilan biologique adéquat (LNS : limite normale supérieure) :
    · bilirubine normale
    · taux de transaminases et de phosphatases alcalines £ 2.5 LNS
    · créatininémie < 140 mmol/L ou clairance de la créatinine > 60 mL/min
    · taux de polynucléaires neutrophiles supérieur à 2.109 L-1
    · taux de plaquettes supérieur à 100.109 L-1
    · hémoglobine ≥ 10 g/dL.
    - Absence d’insuffisance hépatique, rénale ou cardiaque sévère relative au traitement.
    - Absence de pathologie gastro-intestinale non traitée.
    - Patient ayant signé le consentement de participation avant l’entrée dans l’étude.
    - Affiliation à un régime de Sécurité Sociale (ou être bénéficiaire d’un tel régime) selon les termes de la loi du 9 août 2004.
    E.4Principal exclusion criteria
    - Age < 18 ans.
    - Femme enceinte ou allaitante, ou en âge de procréer et n’utilisant pas une contraception efficace.
    - Cible non mesurable et/ou cible osseuse seule.
    - Patient sous tutelle.
    - Patient atteint de déficience mentale ne leur permettant pas une bonne compréhension du protocole ou une bonne compliance au traitement.
    - Patient ayant des antécédents de deuxième cancer, exception faite d’un cancer in situ du col utérin ou d’un cancer basocellulaire cutané considéré comme guéri.
    - Traitement concomitant par un médicament en expérimentation.
    - Patient présentant une autre pathologie jugée comme incompatible avec l’entrée du patient dans le protocole.
    - Insuffisance cardiaque, rénale, médullaire, respiratoire ou hépatique.
    - Antécédents de syndrome de malabsorption ou de résection étendue du tractus digestif supérieur.
    - Infection intercurrente non contrôlée.
    - Pathologie auto-immune et/ou inflammation chronique active.
    - Anomalies neurologiques ou psychiatriques significatives.
    - Présence d’atteinte du système nerveux central (SNC) symptomatique ou évolutive ou présence de métastases cérébrales au bilan initial.
    - Neuropathie périphérique ³ grade 2 selon les critères du National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 3.0).
    - Antécédents d’allergies au Polysorbate 80.
    - Traitement par anti-inflammatoires non stéroïdiens (AINS) et/ou inhibiteurs de la cyclooxygénase-2 (COXIBS) datant de moins 3 semaines.
    - Traitement concomitant par un médicament en essai ou participation à un autre essai clinique dans un délai < 30 jours
    - Prise régulière de compléments alimentaires.
    - Patient non stable géographiquement dans les 6 mois suivants ou demeurant loin du centre de traitement et rendant difficile son suivi.
    E.5 End points
    E.5.1Primary end point(s)
    - Taux de réponse objective (RC + RP) et bénéfice clinique (RC + RP + ST), selon les critères RECIST, dans les 2 bras de traitement.
    - Survie globale et le temps jusqu’à progression dans les 2 bras de traitement.
    - Tolérance dans les 2 bras de traitement.
    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 No
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    TAXOTERE
    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 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
    Comparer les taux de réponses objectives (RC + RP) de cancers du sein inopérables, en rechute locale ou métastatiques, Her2 négatifs, en première ligne ou deuxième ligne de traitement par Taxotère® seul ou par l'association Taxotère® + curcumine.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 Decision2008-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-10-30
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