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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   39229   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-016708-21
    Sponsor's Protocol Code Number:GINECO-BR108
    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:2010-01-08
    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 number2009-016708-21
    A.3Full title of the trial
    Essai multicentrique de phase II évaluant l'efficcacité et la tolérance de l'association de bevacizumab, paclitaxel et capecitabine en première ligne chez des patientes atteintes de cancer du sein métastatique ou localement avancé récepteurs triples negatifs .
    A.3.2Name or abbreviated title of the trial where available
    A-taxel
    A.4.1Sponsor's protocol code numberGINECO-BR108
    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 SponsorARCAGY
    B.1.3.4CountryFrance, Metropolitan
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameBevacizumab
    D.3.2Product code R04876646
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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.3.8INN - Proposed INNbevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMab VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 mg to 4 mL
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorps monoclonal recombiné humanisé (Recombinant humanised monoclonal antibody)
    D.IMP: 2
    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 paclitaxel
    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 namePaclitaxel
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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.3.8INN - Proposed INNPaclitaxel
    D.3.9.1CAS number 33069624
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6 to 1
    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 Yes
    D.3.11.13.1Other medicinal product typeAgent cytostatique (antimicrotubules)
    D.IMP: 3
    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 150 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namecapecitabine Xeloda
    D.3.2Product code Code CIP : 3657456
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 4
    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 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namecapecitabine Xeloda
    D.3.2Product code Code CIP : 3657462
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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
    Le recours à l’association de paclitaxel en administration hebdomadaire à 80 mg par mètre carré trois semaines sur quatre et de la capécitabine cinq jours sur sept à la dose de 1600 mg par mètre carré par jour avec une thérapeutique anti-angiogénique telle que le bevacizumab pourrait permettre d’optimiser le schéma thérapeutique aussi bien en terme de réponse que de survie sans rechute avec un profil de tolérance acceptable dans la population des patientes atteintes d’un cancer du sein métastatique « triple négatif ».
    Objectif Primaire : Taux de réponse
    E.2.2Secondary objectives of the trial
    Objectifs Secondaires :
    - Bénéfice clinique
    - Durée de réponse
    - Tolérance
    - Survie sans progression
    - Survie globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age supérieur à 18 ans
    -Adénocarcinome mammaire métastatique ou localement avancé, histologiquement prouvé
    -Récepteurs hormonaux RP et RE négatifs et statut HER 2 négatif
    -Présence de lésion(s) mesurable(s)
    -Patiente ayant pu être traitée en adjuvant à condition d’être en progression au moment de son entrée dans l’étude (traitement antécédent en adjuvant par anthracycline- et/ou taxane- possible avec un intervalle libre de trois mois maximum)
    -Etat de performance ECOG : 0 ou 1
    -Espérance de vie > 3 mois
    -Bilan biologique satisfaisant, tous les critères suivants doivent être vérifiés :
    •Polynucléaires neutrophiles  1,5  109 /L
    •Plaquettes  100  10 9/L
    •Hémoglobine > 9 g/dL
    •Bilirubine  1,5  LSN (Limite Supérieure Normale), sauf si l’élévation du taux de la bilirubine est due à la maladie de Gilbert ou autre syndrome similaire concernant le ralentissement de la conjugaison de la bilirubine ET
    •ASAT et ALAT < 1,5  LSN pour les patientes sans métastases hépatiques et < 3 x LSN si présence de métastase hépatiques
    •Créatininémie  1,25  LSN ou clairance de la créatinine  50 mL/min calculée selon la formule de Cockroft-Gault
    •Protéinurie à la bandelette urinaire < 2+, (si > 2+, la protéinurie de 24h doit être < 1 g)
    •Chez les patientes ne recevant pas de traitement anticoagulant : INR < 1,5 et Taux de prothrombine (TP) ou temps de céphaline activée (TCA) < 1,5 LSN dans les 7 jours qui précèdent l’inclusion
    •Les patientes qui reçoivent des anticoagulants oraux ou parentéral peuvent être incluses dans l’essai si le taux d’anticoagulation est stable depuis au moins 2 semaines avant l’inclusion. Les tests de coagulation pour vérifier l’hémostase sont ceux utilisé localement

    -Toute patiente en âge de procréer doit utiliser une contraception adéquate. Le test urinaire de grossesse doit être négatif dans les 7 jours précédant le début du traitement de l’étude
    -Absence de toute situation psychologique, familiale, sociale ou géographique susceptible de gêner la compliance de la patiente ou le suivi de l’étude
    -Consentement éclairé signé
    E.4Principal exclusion criteria
    -Chimiothérapie antérieure en situation métastatique
    -Présence de métastases cérébrales ou méningées symptomatiques
    -Antécédent d’un autre cancer, à l’exception de cancers convenablement traités et guéris et sans signe de récidive depuis au moins 5 ans.
    -Maladie cardiaque cliniquement significative (accident cardio-vasculaire ou infarctus du myocarde dans les 6 derniers mois précédant l’inclusion, angor instable, insuffisance cardiaque congestive classe NYHA ≥ II, troubles de rythme, dyspnée nécessitant un repos strict ou une oxygénation permanente)
    -Antécédents de maladie thrombotique ou hémorragique dans les 6 mois précédent l’inclusion
    -Antécédents de coagulopathie
    -Plaie, ulcère ou fracture osseuse non cicatrisés
    -Chirurgie majeure, plaie traumatique significative dans les 28 jours précédant le début du traitement ou anticipation d’une chirurgie majeure durant l’étude
    -Chirurgie mineure y compris l’insertion d’une chambre implantable dans les 24 heures précédant la première perfusion de bevacizumab
    -Diabète non équilibré
    -Participation à une autre étude clinique avec des médicaments expérimentaux dans les 30 jours qui précèdent l’entrée dans l’étude
    -Traitement anticancéreux concomitant
    -Femme enceinte ou allaitant ou femme en âge de procréer et n’utilisant pas de contraception adéquate pendant l’étude et au minimum 6 mois après la fin de l’étude
    -Hypertension artérielle non contrôlée (pression artérielle > 150/100 mmHg malgré un traitement anti-hypertenseur)
    -Prise en cours ou récente de tout anti-inflammatoire non stéroidien (aspirine sup. à 325 mg/j), ou antiaggrégants (dypiridamole, ticlopidine ou clopidogrel > 75 mg/j dans les 10 jours précédant la première administration de bevacizumab
    -Prise en cours ou récente (dans les 10 jours précédents la première dose de bevacizumab) d’un agent thrombolytique à but thérapeutique
    -Antécédents de fistule abdominale, perforation gastro-intestinales, ou d’abcès intra abdominal dans les 6 mois précédant l’inclusion
    -Patiente affectée par une maladie neurologique ou un dysfonctionnement métabolique. Examen physique ou de laboratoire faisant suspecter une maladie ou une condition contre indiquant l’utilisation du traitement à l’étude ou exposant la patiente à un grand risque de complications liées au traitement
    -Hypersensibilité connue au bevacizumab ou à un dérivé de cellule ovarienne de hamster, ou à la Capecitabine ou au paclitaxel ou un de leurs excipients
    -Antécédents de réaction inattendue après un traitement à la fluoropyrimidine, ou une allergie connue au fluorouracil
    -Neuropathie sensitive ou motrice préexistante de grade > 2
    E.5 End points
    E.5.1Primary end point(s)
    -Taux de réponse objective selon les critères RECIST.1.1
    -Toxicités selon les critères CTCAE v4.0
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned40
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA40
    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
    18 mois d'inclusion + 6 mois de médiane de traitement + 24 mois de suivi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 62
    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 Decision2010-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-03
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