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    Summary
    EudraCT Number:2009-014096-46
    Sponsor's Protocol Code Number:P090402
    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:2009-08-06
    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 number2009-014096-46
    A.3Full title of the trial
    Essai thérapeutique de phase IIa ouvert, multicentrique, évaluant l'intérêt du Pazopanib dans les dermatofibrosarcomes de Darier-ferrand (DFSP) inopérables ou localement avancés (intervention mutilante ou délabrante), récidivants ou transformés en fibrosarcomes avec persistance de la translocation (17,22). Etude pharmacodynamique.
    A.4.1Sponsor's protocol code numberP090402
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 No
    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 namepazopanib
    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.3.8INN - Proposed INN5-[(2,3-Dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]-2-methylbenzenesulfonamide monohydrochloride
    D.3.9.3Other descriptive namePazopanib hydrochloride (USAN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 et 400
    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
    Dermatofibrosarcome protubérant (DFSP) ou sarcome de Darrier-Ferrand.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10057070
    E.1.2Term Dermatofibrosarcome protubérant
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Déterminer le taux de réponse clinique après 6 mois de traitement par pazopanib 800 mg/jour en une prise orale selon les critères RECIST ; l'hypothèse est une diminution de la taille de la tumeur (RECIST) d'au moins 30% chez au moins 50 % des patients après traitement par pazopanib 800 mg/jour à 6 mois
    E.2.2Secondary objectives of the trial
    Evaluer :
    Le taux de réponse clinique selon les critères OMS (WHO)
    Le taux de réponse radiologique par scanner multibarette en utilisant les critères RECIST et OMS (WHO) et par mesure du volume de la tumeur. En cas d'allergie à l'iode une IRM sera effectuée à la place du scanner multibarette.
    Les facteurs pronostiques de réponse tumorale ( la réponse clinique et radiologique est-elle associée:
    -à une mort cellulaire par apoptose, nécrose ou senescence ?
    -à l'inactivation de la cible (PDGFR)
    -à la modification de l'expression des isoformes du VEGF
    - à l'inactivation des voies de signalisation en aval de VEGFR2 et PDGFR
    La tolérance clinique et biologique
    Les conséquences du traitement sur la qualité de vie des patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age > ou égal à 20 ans
    Consentement signé
    DFSP primitive inopérables, localement avancés (intervention potentiellement mutilante ou délabrante), récidive locale de DFSP, ou DFSP transformés en fibrosarcomes (dans ce cas la présence de la translocation 17,22 sera requise pour l'inclusion).
    Tumeur de taille>2cm / maladie mesurable selon les critères RECIST et OMS
    Confirmation histologique de la tumeur de Darier-Ferrand, les formes transformées seront acceptées sous réserve d'un caryotype préalable confirmant la présence de la translocation 17,22
    Contraception efficace chez les femmes
    Utilisation de préservatifs ou abstinence pendant la durée de l'étude pour les hommes ayant des partenaires en âge d'être enceinte, inclus dans l'étude
    Absence d'autre pathologie tumorale évolutive sauf carcinome baso-cellulaire
    Absence d'antécédent d'hépatite B, C et/ou d'infection VIH 1 ou 2 connu
    ECOG < 2
    Absence d'HTA non contrôlée
    FEVG normale
    Absence d'allongement du QT (QT<480msec)
    Hémostase normale (TP, TCK)
    Créatinine sérique < 1.5 mg/dL ou Clearance calculée de la créatinine = 30 mL/min
    Protéinurie Trace ou+1 à la bandelette ou <1g sur les urines de 24h
    E.4Principal exclusion criteria
    Age < 20 ans
    Refus du patient
    Incapacité de donner son consentement éclairé
    Femme enceinte ou allaitante (annexe 9)
    Autre pathologie tumorale évolutive sauf carcinome baso-cellulaire
    ECOG >2
    Infection Hépatite B, C et/ou VIH connue
    Traitement concomitant par drogues interférant avec le métabolisme de pazopanib
    Désordres gastro-intestinaux incluant:
    -un syndrome de malabsorption ou affection ou chirurgie induisant un risque de malabsorption de la drogue
    -Ulcère actif gastro-duodénal
    -Maladie inflammatoire du tube digestif
    -Colite ulcérée, œsophagite ou gastrite ulcérée, maladie infectieuse ou inflammatoire du tube digestif, diverticulite ou autres pathologie gastro-intestinale comportant un risque de perforation.
    -Antécédent de fistule abdominale, perforation gastro-intestinale ou abcès intra-abdominale dans les 28 jours précédant le traitement.
    Notion de chirurgie profonde ou de biopsie chirurgicale profonde ou de traumatisme interne datant de moins de 4 semaines. Nécessité d'intervention programmée durant l'étude
    Infection non contrôlée
    HTA non équilibrée (=140/90) (nécessite de prise de tension à 2 reprise à au moins 5 minutes d'intervalle avant inclusion dans l'essai
    Pathologie cardiovasculaire avec stade NYHA > II
    FEVG diminuée
    Anomalies suivantes sur l'ECG : onde Q, ischémie, QTc > 450 msec, BAV 2 ou 3, fibrillation auriculaire
    Antécédents dans les 6 derniers mois d'au moins une des affections suivantes :
    -pontage, angioplastie, stent
    -Infarctus du myocarde
    -angor instable
    -accident thromboembolique même transitoire
    -Insuffisance cardiaque classe 3 ou 4 by the New York Heart Association (annexe 10 du protocole)
    Saignement actif ou troubles de l'hémostase induisant un risque de saignement
    Prise de traitement anticoagulant.
    Prise d'aspirine au long cours (= 100mg/jour) ou d'agents anti-inflammatoires susceptibles d'inhiber la fonction plaquettaire
    Prise de dipyridamole, ticlopidine, clopidogrel et/ou cilostazol
    Prise d'une autre molécule dans le cadre d'un essai clinique
    Hypersensibilité connue à des agents proches sur le plan moléculaire de pazopanib
    Traitement antérieur par imatinib mésylate ou autre inbibiteur de PDGFR ou antiangiogénique
    Prise d'autres traitements anti-cancéreux
    E.5 End points
    E.5.1Primary end point(s)
    Diminution du plus grand diamètre de la tumeur mesurée cliniquement supérieure ou égale à 30% à 6 mois, (RECIST)
    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 Yes
    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 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 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 concerned13
    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 years4
    E.8.9.1In the Member State concerned months6
    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 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 2009-08-06. 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 state26
    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 Decision2009-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-12
    P. End of Trial
    P.End of Trial StatusOngoing
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