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    Summary
    EudraCT Number:2014-001273-13
    Sponsor's Protocol Code Number:38RC14.040
    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:2015-08-24
    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 number2014-001273-13
    A.3Full title of the trial
    Traitement des carcinomes à cellules de Merkel inopérables et/ou métastatiques par analogue de la somatostatine - Etude Nationale multicentrique mono-bras de phase II - PHRC Merkel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial with somatostatine analog treatment in merkel carcinoma patients.
    essai clinique de traitement par analogue de la somatostatine chez les patients atteints de carcinome de Merkel.
    A.3.2Name or abbreviated title of the trial where available
    PHRC MERKEL
    A.4.1Sponsor's protocol code number38RC14.040
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital of Grenoble
    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 supportMinistery (PHRC)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportIPSEN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Grenoble
    B.5.2Functional name of contact pointCIC Cancérologie
    B.5.3 Address:
    B.5.3.1Street AddressCS 10217
    B.5.3.2Town/ cityGrenoble
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number33476769481
    B.5.5Fax number33476765847
    B.5.6E-mailChMendoza@chu-chu-grenoble.fr
    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 SOMATULINE
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN Pharma
    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 nameLanreotide
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    merkel cell carcinoma
    carcinome à cellules de Merkel
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’efficacité du lanréotide à 3 mois chez des patients atteints d’un carcinome de Merkel (MCC) inopérables et/ou métastatiques.
    E.2.2Secondary objectives of the trial
    - Evaluation du critère principal à 6 mois, 9 mois, 12 mois, 15 mois, 18 mois, 21 mois et 24 mois.
    - Description de la survie globale et de la durée sans progression
    - Evaluation de la place des SPECT-CT et TEP-CT pour la stadification et l’évaluation tumorale des MCC
    - Description de la corrélation entre les résultats du SPECT-CT et la réponse au traitement, et la corrélation entre les résultats du TEP-CT et la réponse au traitement.
    - Description de la sécurité et de la tolérance du Lanréotide pour ces patients.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    étude sur biopsie par immunohistochimie (IHC) des récepteurs à la somatostatine et à la dopamine ainsi que le polyomavirus MCPyV exprimés dans le MCC (au niveau de la tumeur primaire et/ou à partir des métastases si accessibles) et d’évaluer une possible corrélation avec la réponse au traitement.
    E.3Principal inclusion criteria
    - Tumeur de Merkel inopérable ou métastatique histologiquement confirmée de stade III B ou IV (selon classification de l’AJCC 2010)
    - Première ligne de traitement ou plus
    - Au moins une cible mesurable de plus de 20 mm avec un scanner conventionnel ou de plus de 10 mm avec un scanner spiralé ou cibles cliniques évaluables.
    - Patient âgé de plus de 18 ans
    - PS compris entre 0 et 3
    - Aucune autre tumeur maligne dans les 5 dernières années sauf carcinome basocellulaire ou épidermoïde traité de manière adéquate ou cancer in situ du col utérin.
    - Pas de chimiothérapie, d’immunothérapie ou d’hormonothérapie concomitante.
    - Un délai d’au moins 4 semaines doit être respecté avant le début du traitement après une chimiothérapie adjuvante, ou 14 jours suite à une séance de radiothérapie ou après une chirurgie.
    - Bilan biologique : neutrophiles > 1000/mm3, plaquettes > 100000/mm3, hémoglobine > 9g/dl (transfusion autorisée), bilirubine pas supérieure à 3 fois la limite supérieure, SGOT and SGPT pas supérieur à 2.5 fois la limite supérieure, créatinine pas supérieure à 1.5 fois la limite supérieure.
    - Pas de diabète ou d’infection non traités, ni de maladie chronique du foie, ni de maladie chronique du rein.
    - Prise d’une contraception efficace pour les femmes en âge de procréer
    - Personne affilié à la sécurité sociale ou bénéficiaire d’un tel régime
    - Consentement éclairé et écrit signé par le patient
    E.4Principal exclusion criteria
    - Patient allergique ou hyper sensible au Lanréotide
    - Patient atteint de lithiase biliaire compliquée ou non traitée
    E.5 End points
    E.5.1Primary end point(s)
    Le traitement sera considéré comme efficace si 40 % des patients ont une réponse positive. La réponse positive est définie par l’ensemble des patients ayant soit une réponse complète, soit une réponse partielle, soit une réponse stable selon les critères RECIST 1.1. Les évaluations se feront sur la clinique et par scanners à 3 mois pour tous les patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    à 3 mois
    E.5.2Secondary end point(s)
    - Ré-évaluer la réponse positive à 6 mois, 9 mois, 12 mois, 15 mois, 18 mois, 21 mois et 24 mois.
    - Evaluer la survie globale et de la survie sans progression à 6 mois, 9 mois, 12 mois, 15 mois, 18 mois, 21 mois et 24 mois.
    - Evaluer la place de l’octréoscan et du PET-Scan pour définir le stade du MCC au diagnostic et pour l’évaluation tumorale des MCC.
    - Evaluer la corrélation entre les résultats de l’octréoscan et la réponse au traitement, et évaluer la corrélation entre les résultats du PET-Scan et la réponse au traitement.
    - Evaluer la tolérance du Lanréotide pour ces patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    à 6 mois, 9 mois, 12 mois, 15 mois, 18 mois, 21 mois et 24 mois
    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 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 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 No
    E.8.1.2Open Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned34
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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 No
    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
    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 months0
    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 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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state35
    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 d’arrêt les patients seront suivis et traités selon la décision prise en Réunion de Concertation Pluridisciplinaire de cancérologie cutanée.
    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 Decision2014-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-15
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