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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   41472   clinical trials with a EudraCT protocol, of which   6816   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2006-004573-95
    Sponsor's Protocol Code Number:ALIMESO-0604
    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:2007-03-26
    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 number2006-004573-95
    A.3Full title of the trial
    Etude pharmacologique du Pemetrexed (Alimta) administré avec Cisplatine et supplémentation vitaminique chez des patients porteurs d'un mésothéliome pleural non résécable
    A.3.2Name or abbreviated title of the trial where available
    ALIMESO
    A.4.1Sponsor's protocol code numberALIMESO-0604
    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 SponsorCentre Oscar Lambret
    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 Alimta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Netherland B.V
    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.3.1Product nameAlimta
    D.3.4Pharmaceutical form Powder 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 INNPemetrexed
    D.3.9.1CAS number 150399-23-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    mésothéliome pleural
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10035605
    E.1.2Term Pleural mesothelioma malignant advanced
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10035606
    E.1.2Term Pleural mesothelioma malignant localised
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059518
    E.1.2Term Pleural mesothelioma malignant
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10035607
    E.1.2Term Pleural mesothelioma malignant recurrent
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Définir un protocole d’adaptation individuelle de posologie de Pemetrexed (Alimta®) administré à la dose initiale de 500 mg/m² avec Cisplatine et supplémentation vitaminique.
    E.2.2Secondary objectives of the trial
    - Confirmer les relations entre les paramètres pharmacocinétiques et pharmacodynamiques (hématologiques et non-hématologiques) après administration de Pemetrexed (Alimta®) à la dose de 500 mg/m2
    - Analyser les variations pharmacocinétiques inter-individuelles et l’influence des covariables sur la pharmacocinétique du Pemetrexed (Alimta®)
    - Analyser les variations pharmacogénétiques (MTHFR, TS, GSTpi, ERCC1, XPD) qui influencent la toxicité du Pemetrexed (Alimta®)
    - Valider une stratégie d’adaptation de posologie du Pemetrexed (Alimta®)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient présentant un mésothéliome pleural non résécable diagnostiqué par histologie
    - Tout stade
    - N’ayant pas reçu de chimiothérapie antérieure
    - Délai de 28 jours en cas de radiothérapie préalable (21 jours si radiothérapie des trajets de ponction)
    - Age > ou = 18 ans
    - Performance status < ou = 2
    - Espérance de vie > 3 mois
    - PNN > ou = 1500 /mm3, Plaquettes > ou = 100 000/mm3
    - Bilirubine totale ≤ 1.5 x la limite supérieure de la normale (LSN)
    - ASAT et ALAT ≤ 3 x LSN (≤ 5 x LSN si métastases hépatiques)
    - Clairance créatinine > 45 mL/min
    - Patient ayant une voie d’abord pour l’administration intraveineuse de la chimiothérapie indépendante de celle utilisée pour les prélèvements sanguins
    - Contraception efficace (hommes et femmes) pendant et durant les 6 mois qui suivent la fin du traitement
    - Patient ayant signé le consentement éclairé, écrit
    E.4Principal exclusion criteria
    - Hypersensibilité au Pemetrexed (Alimta®) ou à l’un des excipients
    - Vaccin contre la fièvre jaune
    - Patient qui ne peut être suivi régulièrement pour des raisons psychologiques, sociales, familiales ou géographiques
    - Incapacité de cesser l'administration d'aspirine à une dose > 1.3 g/jour ou d'autres agents anti-inflammatoires non-stérodiens dans les 2 jours qui précèdent, le jour même et les 2 jours qui suivent l’administration de Pemetrexed (dans les 5 jours qui précèdent pour des agents à action lente comme le Piroxicam)
    - Ascite ou épanchement pleural, détecté(e) à l’examen clinique qui ne peut pas être contrôlé par drainage ou autres procédures
    - Patient dont l’état veineux ne permet pas la mise en place d’une voie d’abord périphérique pour réaliser les prélèvements sanguins
    - Neuropathie périphérique de grade > ou = 2
    - Incapacité à prendre une vitaminothérapie ou une corticothérapie
    - Femme enceinte ou allaitante
    - Participation à une étude clinique comportant une molécule expérimentale
    E.5 End points
    E.5.1Primary end point(s)
    - Critères pharmacocinétiques (PK) :
    L’élaboration et l’analyse du modèle pharmacocinétique de population seront réalisées au moyen du programme NONMEM. L’analyse recherchera une influence des covariables (poids, surface corporelle, taille, âge, sexe, créatinine sérique, cystatine C, marqueurs prédictifs d’un déficit en folates…) sur un ou des paramètres pharmacocinétiques
    La détermination du nombre minimum de prélèvements pour adapter les posologies sera établie en fonction de l’ensemble de ces critères préalablement établis.

    - Les critères pharmacogénétiques (PG) :
    Le polymorphisme constitutionnel des gènes (MTHFR, TS, GSTī°, ERCC1, XPD) sera mesuré avant le traitement par RT-PCR quantitative en temps réel.

    - Critères pharmacodynamiques (PD) :
    La tolérance sera mesurée à l’aide de l’échelle de cotation NCI-CTCAE version 3.0, à chacun des cycles de chimiothérapie.

    - Les relations PK/PG /PD :
    Elles seront analysées par le programme NONMEM. Dans un premier temps, la mise au point d’un modèle intégré PK/PD sera tentée (la myélosuppression est une fonction de la concentration plasmatique de médicament et le modèle pharmacodynamique correspondant inclut plu-sieurs compartiments de transit avec rétrocontrôle). Eventuellement, une relation entre le pourcentage de diminution des polynucléaires neutrophiles et celui des plaquettes avec l’exposition plasmatique (ASC) pourra être recherchée. La relation entre la fonction rénale et les paramètres PK seront particulièrement analysés.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 concerned6
    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 No
    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
    La durée de participation du patient dans l’étude est d’au moins 3 cycles de chimiothérapie, espacés de 21 jours avec une surveillance clinique post-traitement à 21 jours.
    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 state60
    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)
    Le patient pourra recevoir 3 cycles supplémentaires de chimiothérapie, en fonction de l’évaluation tumorale réalisée en fin de 3ème cycle.
    A la fin de leur participation à l'étude, les patients bénéficieront d'une surveillance car, à ce jour il n'y a pas d'indication de chimiothérapie de maintenance.
    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 Decision2007-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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