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    Summary
    EudraCT Number:2008-000198-39
    Sponsor's Protocol Code Number:P071203
    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:2008-03-10
    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 number2008-000198-39
    A.3Full title of the trial
    Evaluation de l'activité protectrice du mangafodipir contre la neuropathie induite par l'oxaliplatine
    A.3.2Name or abbreviated title of the trial where available
    MNDPDP-K04
    A.4.1Sponsor's protocol code numberP071203
    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 Yes
    D.2.1.1.1Trade name Teslascan
    D.2.1.1.2Name of the Marketing Authorisation holderGE Heathcare AS
    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 nameTeslascan
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMangafodipir trisodique anhydre
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.91
    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
    Patients atteints au moment de l'inclusion d'une neuropathie périphérique de grade 2 ou plus, aiguë ou persistant après les injections d'oxaliplatine, quel que soit le cancer ayant motivé le traitement et quel que soit le protocole pourvu qu'il comporte l'administration d'oxaliplatine pendant au moins quatre cycles.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10029328
    E.1.2Term neuropathies
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Déterminer si l'adjonction de mangafodipir à l'oxaliplatine empêche l'aggravation ou diminue la gravité de la neuropathie périphérique de grade 2 ou plus induite par l'oxaliplatine
    E.2.2Secondary objectives of the trial
    - Déterminer le nombre moyen de cycles d'oxaliplatine rendus possibles par l'adjonction du mangafodipir à l'oxaliplatine.
    - Evaluer la fréquence des arrêts de traitement pour cause de neurotoxicité inacceptable
    - Obtenir des données préliminaires sur l'efficacité de l'association oxaliplatine - mangafodipir en termes de survie sans progression tumorale
    - Evaluer l'accumulation intra-érythrocytaire de manganèse après chaque injection de mangafodipir
    - Pharmacodynamie : L'activité biologique du mangafodipir sera évaluée par les dosages sériques de l'activité antioxydante globale, de l'activité SOD et de la peroxydation lipidique après la première injection
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients atteints au moment de l'inclusion d'une neuropathie périphérique de grade 2 ou plus, aiguë ou persistant après les injections d'oxaliplatine, quel que soit le cancer ayant motivé le traitement et quel que soit le protocole pourvu qu'il comporte l'administration d'oxaliplatine pendant au moins quatre cycles.
    -Age > 18 ans
    -PS < 2 et espoir de vie > 3mois (cf annexe 1)
    -Ayant donné son consentement éclairé écrit
    -Paramètres biologiques normaux ou subnormaux : polynucléaires neutrophiles > 1.5 x 109/L ; plaquettes > 80 x 109/L ; hémoglobine > 8 g/dL ; bilirubine plasmatique totale < 1,5 x la limite supérieure de la normale (LSN), transaminases < 3 x LSN (5 x LSN en cas de métastases hépatiques) ; clairance calculée (Cockroft & Gault) de la créatinine > 30 mL/min.
    E.4Principal exclusion criteria
    -Contre-indication à l'oxaliplatine selon le Résumé des Caractéristiques du Produit (RCP).
    -Résistance certaine à l'oxaliplatine définie par une progression tumorale sous ce traitement ou la survenue d'une progression tumorale dans les trois mois suivant son arrêt.
    -Femmes enceintes ou allaitantes, patients des deux sexes n'utilisant pas une contraception efficace.
    -Association à un autre produit à visée anti-tumorale que ceux décrits précédemment ou à un autre produit expérimental, ou participation à une autre étude clinique : pendant l'étude ou dans les 3 semaines précédant la 1ère administration ou suivant la dernière administration du traitement de l'étude.
    -Infection non contrôlée.
    -Non affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit).
    -Patients qui pour des raisons d'affection médicale concomitante sévère, sociales, psychologiques, ou géographiques, risqueraient de ne pas adhérer aux astreintes de l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    - Présence et sévérité de la neuropathie évaluée à chaque cycle par l'investigateur ainsi que lors d'une consultation ayant lieu un mois après le dernier cycle (3 à 5 semaines). Un score NCI sera établi. La toxicité la plus sévère constatée chez un patient sera pris comme critère d'évaluation

    - Evolution de la neuropathie :
    Aggravation de la neuropathie : définie par une aggravation d'un grade ou plus après au moins une injection d'oxaliplatine et mangafodipir
    Stabilisation de la neuropathie : stabilité du grade de la neuropathie pendant au moins 4 injections
    Amélioration de la neuropathie : diminution de la neuropathie d'au moins un grade pendant au moins deux mois.
    La prévention d'une aggravation se traduira par l'absence d'augmentation du grade pendant la durée de l'étude. L'amélioration se traduira par la diminution du grade de la neuropathie pendant l'étude, malgré la poursuite du traitement. Le traitement sera considéré comme efficace si la neuropathie reste stable ou diminue chez au moins 50% des patients.

    - Nombre de cycles d'oxaliplatine qui peuvent être administrés lorsque l'on associe du mangafodipir chez des patients présentant une neuropathie de Grade 2 ou plus.

    - Survie sans progression tumorale sera calculée de la date d'entrée dans l'étude jusqu'à la date où la progression est documentée la première fois, ou censurée à la date de la dernière évaluation ne montrant pas de progression si la tumeur n'a pas progressé à la date de fin de collection des données de l'étude. Les cibles tumorales seront évaluées par scanner dans les quatre semaines précédant le début du traitement puis tous les 4 cycles. La progression tumorale sera évaluée selon les critères 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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.7.1.3.1Other trial type description
    administration hors indication ; nouvelle posologie
    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 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 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 years1
    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 2008-03-10. 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 state25
    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 Decision2008-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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