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    Summary
    EudraCT Number:2010-022329-13
    Sponsor's Protocol Code Number:4791
    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:2010-09-03
    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 number2010-022329-13
    A.3Full title of the trial
    Etude de phase I associant la rapamycine et l’irinotecan dans toutes tumeurs solides réfractaires de l’enfant
    A.3.2Name or abbreviated title of the trial where available
    RAPIRI
    A.4.1Sponsor's protocol code number4791
    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 SponsorHôpitaux Universitaires de Strasbourg
    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.2.5The 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 nameIRINOTECAN
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNirinotecan
    D.3.9.3Other descriptive namecamptothecin-11 (CPT-11)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 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 RAPAMUNE 1mg/mL
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Oral solution
    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
    Tumeurs solides réfractaires de l'enfant
    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
    a. Déterminer la dose maximale tolérée (DMT) de l’association thérapeutique d’irinotecan et de rapamycine dans toutes tumeurs solides réfractaires pédiatriques
    b. Evaluer la pharmacocinétique de la rapamycine et de l’irinotecan au cours du 1er cycle de chimiothérapie.
    E.2.2Secondary objectives of the trial
    a. Evaluer la tolérance de la combinaison [irinotecan + rapamycine] et déterminer des profils de toxicité ;
    b. Evaluer l’impact de l’association irinotécan / rapamycine sur l’angiogenèse tumorale ;
    c. Déterminer les doses de rapamycine et d’irinotecan n’ayant pas ou peu de toxicité et qui ont une activité inhibitrice maximale sur la voie mTor/HIF-1alpha sans induction des mécanismes de résistance (dus à la levée de la boucle d’autorégulation de la voie mTor).
    d. Déterminer l’approche radiologique la plus adaptée afin d’évaluer de façon préliminaire l’effet anti-glycolytique et anti-angiogénique de cette association dans la perspective d’un essai de phase II ;
    e. Evaluer la tumeur en cas de maladie mesurable ou visible.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age compris entre 1 an et 21 ans
    - Toute tumeur solide réfractaire, prouvée histologiquement au diagnostic (pas de biopsie additionnelle requise pour l’entrée dans cette phase I)
    - Une tumeur maligne solide réfractaire ou en rechute après un traitement consensuel ou d’étude clinique de phase III-IV et II
    - Karnofsky ou statut de Lansky d’au moins 70%
    - Une espérance de vie d’au moins 8 semaines
    - Pas de chimiothérapie et/ou de radiothérapie dans les 4 semaines qui précèdent l’inclusion
    - Une biologie avec les normes suivantes :
    *polynucléaires neutrophiles ≥ 1.0 x 10^9/L
    *plaquettes ≥ 100 x 10^9/L
    *hémoglobine ≥ 8 mg/dL
    *bilirubine totale ≤ 1.5 ULN
    *transaminases ≤ 2.5 ULN (≤ 5 ULN si présence de métastases hépatiques)
    *clairance de la créatinine (Cockroft) ≥ 70 mL/min/1.73 m2
    *bilan de coagulation normal (taux de prothrombine ≥ 70%, TCA ≤ 35 et fibrinogène ≥ 2 g/L) ;
    - Patients avec 3 lignes thérapeutiques préalables au maximum ;
    - Absence de toxicité d’organes de grade > 2 selon codification NCI-CTCAE v3.0
    - Contraception efficace pour les patients (des deux sexes) en âge de procréer
    - Test de grossesse négatif pour les patientes en âge de procréer
    - Consentement éclairé écrit, signé par le patient majeur ou les 2 parents ou le(s) titulaire(s) de l’autorité parentale des sujets mineurs
    - Personne bénéficiant d’un régime de Sécurité Sociale
    - Patient ayant été informé des résultats de la consultation médicale préalable.
    E.4Principal exclusion criteria
    - Patient porteur d’une anomalie constitutionnelle de la coagulation et/ou de l’hémostase (type hémophilie, maladie de Willebrand, déficit congénital en facteur de coagulation, thrombopathie), exposant à un risque accru de saignement
    - Pré-traitement avec un inhibiteur de mTor
    - Traitement anti-tumoral concomitant
    - Autre pathologie maligne simultanée
    - Hypersensibilité connue ou contre-indication aux drogues de l’étude
    - Maladie sévère concomitante (exemple, infection)
    - Patient ayant en cours un traitement interférant avec la pharmacologie de l’irinotecan et/ou la rapamycine (cf traitement) notamment toute drogue interagissant avec le CYP3A4
    - Inclusion concomitante dans une autre étude de médicament
    - Sujet sous sauvegarde de justice
    - Impossibilité au patient de se soumettre au suivi médical de l’essai pour des raisons géographiques, sociales ou psychiques
    - Grossesse ou allaitement en cours pour les jeunes femmes
    E.5 End points
    E.5.1Primary end point(s)
    - Recherche de DLT (Toxicité Dose limitante) au 1er cycle (J1 à J28) ; nécessitera l’arrêt du traitement lorsqu’un minimum de 2 patients sur 6 l’expérimentent au cours du 1er cycle.La DMT (dose maximale tolérée) pourra être définie au palier de dose juste inférieur à celui où auront été observées au moins 2 DLT; La DMT sera la dose recommandée en phase II.
    - Paramètres de pharmacocinétique de la rapamycine et de l’irinotecan évalués au cours du 1er cycle de traitement. Le profil de pharmacocinétique sera modélisé pour chaque patient.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pediatric study
    E.7.2Therapeutic exploratory (Phase II) No
    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 No
    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) 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 concerned9
    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
    dernière visite de suivi du dernier patient
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state33
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    En cas de bénéfice pour l'enfant et en l'absence de toxicité avérée, la poursuite de la chimiothérapie (irinotecan+rapamycine) pourra être prolongée après les 6 cycles de traitement, au dehors du protocole (décision au cas par cas).
    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 Decision2010-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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