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    Summary
    EudraCT Number:2009-011049-15
    Sponsor's Protocol Code Number:IB 2009–08
    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:2009-05-28
    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 number2009-011049-15
    A.3Full title of the trial
    Evaluation de l’efficacité du temsirolimus chez des patients récidivant d’un cancer de la vessie après une première ligne de chimiothérapie. Essai clinique de phase II multicentrique.
    A.3.2Name or abbreviated title of the trial where available
    VESTOR
    A.4.1Sponsor's protocol code numberIB 2009–08
    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 SponsorInstitut Bergonié - Département d’Oncologie Médicale
    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 TORISEL 25 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa 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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 de la vessie récidivant
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028983
    E.1.2Term Neoplasm bladder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’efficacité du Temsirolimus (Torisel®) en termes de non-progression à 8 semaines (réponses complètes et partielles, maladie stable selon les critères RECIST mis à jour en 2009).
    E.2.2Secondary objectives of the trial
    - Evaluer la survie sans progression (PFS) à 1 an
    - Evaluer la durée de la réponse
    - Evaluer la survie globale à 1an
    - Evaluer la tolérance au traitement
    - Evaluer la qualité de vie
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Etude biologique : Rechercher et valider de nouvelles cibles génétiques impliquées dans la réponse au traitement. Etude pharmacocinétique du temsirolimus : Evaluer la pharmacocinétique du temsirolimus (Torisel®) Etude TEP : Evaluer l’apport du TEP dans l’évaluation précoce de la réponse au traitement.
    E.3Principal inclusion criteria
    - Patient(e) agé(e) de 18 ans ou plus
    - Cancer de la vessie stade IV histologiquement prouvé
    - Etat général (Echelle ECOG de l’OMS) ≤ à 2
    - Récidive après une première ligne de chimiothérapie
    - Lésions mesurables dans au moins une dimension (Critères RECIST)
    - Absence de traitement antinéoplasique dans les 4 semaines précédant l’inclusion
    - Valeurs biologiques :
    *Taux de polynucléaires neutrophiles >1,5.10^9/L.
    *Taux de plaquettes >100.10^9/L.
    *Bilirubine < 1,5 fois la limite supérieure de la normale.
    *Créatinine ≤ 1,5 fois la limite supérieure de la normale et/ou clairance > ou égal à 60 ml/mm
    *En l’absence de métastases hépatiques : taux de transaminases et de phosphatases alcalines < 2,5 fois la limite supérieure de la normale.
    *En cas de métastases hépatiques : taux de transaminases et de phosphatases alcalines < 5 fois la limite supérieure de la normale.
    - Consentement éclairé signé
    - Patient affilié à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    - Métastases cérébrales connues non contrôlées.
    - Traitement par chimiothérapie, immunothérapie ou radiothérapie dans les 4 semaines précédant l’entrée dans l’étude.
    - Hypersensibilité au temsirolimus, à ses métabolites (notamment le sirolimus), au polysorbate 80 ou à l’un des excipients
    - Antécédents de cancer autre qu’un carcinome baso-cellulaire cutané ou épithélioma in situ du col utérin traités de façon curative.
    - Pathologie auto-immune, psychiatrique ou neurologique évolutive.
    - Pathologie grave évolutive.
    - Pathologie cardiaque non contrôlée.
    - Insuffisance rénale sévère
    - Diabète non contrôlé
    - Grossesse
    - Patient inclus dans une autre étude clinique médicamenteuse,
    - Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques,
    - Patient privé de liberté et majeur faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer son consentement
    E.5 End points
    E.5.1Primary end point(s)
    Progression.
    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 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
    Protéomique, Marqueurs tumoraux
    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 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 concerned8
    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 years3
    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 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 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 state55
    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 Decision2009-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-15
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