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    Summary
    EudraCT Number:2013-001372-37
    Sponsor's Protocol Code Number:ET13-024
    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:2014-03-27
    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 number2013-001372-37
    A.3Full title of the trial
    A randomized, multicentre, phase III trial evaluating the interest of imatinib treatment maintenance or interruption after 3 years of adjuvant treatment in patients with Gastrointestinal Stromal Tumours (GIST)
    Etude de phase III, randomisée, multicentrique, évaluant l’intérêt de la poursuite ou de l’arrêt d’un traitement adjuvant par imatinib après 3 ans dans le traitement des tumeurs stromales gastrointestinales (GIST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the interest of imatinib treatment maintenance or interruption after 3 years of adjuvant treatment in patients with Gastrointestinal Stromal Tumours
    Etude évaluant l’intérêt de la poursuite ou de l’arrêt d’un traitement adjuvant par imatinib après 3 ans dans le traitement des tumeurs stromales gastrointestinales
    A.3.2Name or abbreviated title of the trial where available
    IMADGIST
    A.4.1Sponsor's protocol code numberET13-024
    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 SponsorCENTRE LEON BERARD
    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 supportINCA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCENTRE LEON BERARD
    B.5.2Functional name of contact pointGWENAELE GARIN
    B.5.3 Address:
    B.5.3.1Street Address28 RUE LAENNEC
    B.5.3.2Town/ cityLYON CEDEX 08
    B.5.3.3Post code69373
    B.5.3.4CountryFrance
    B.5.4Telephone number+33426556824
    B.5.5Fax number+33478782715
    B.5.6E-mailgwenaelle.garin@lyon.unicancer.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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameImatinib
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNIMATINIB MESILATE
    D.3.9.1CAS number 220127-57-1
    D.3.9.4EV Substance CodeSUB12517MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    GastroIntestinal Stromal Tumours (GIST)
    Tumeurs Stromales GastroIntestinales (GIST)
    E.1.1.1Medical condition in easily understood language
    GastroIntestinal Stromal Tumours (GIST)
    Tumeurs Stromales GastroIntestinales (GIST)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10062427
    E.1.2Term Gastrointestinal stromal tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical impact, of maintenance versus interruption of imatinib adjuvant treatment beyond 3 years, in patients with resected primary GIST with high risk of recurrence
    Evaluer l’intérêt clinique de la maintenance versus l’interruption d’un traitement adjuvant par imatinib au-delà de 3 ans post-chirurgie chez des patients atteints de GIST réséqués présentant un risque significatif de récidive.
    E.2.2Secondary objectives of the trial
    • To assess overall survival
    • To assess safety and tolerance of imatinib treatment
    • To assess time to secondary resistance
    • To evaluate the rate of patients in complete response (as per RECIST 1.1) after reintroduction of imatinib in case of GIST recurrence in the "interruption" arm
    To assess quality of life
    • Evaluer la survie globale
    • Evaluer la tolérance au traitement
    • Evaluer le temps à résistance secondaire
    • Evaluer le taux de patients en réponse complète (selon les RECIST v1.1) après réintroduction de l’imatinib en cas de récidive dans le bras « interruption »
    Evaluer la qualité de vie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1.Age ≥ 18 years at the day of consenting to the study
    I2.Patients must have histologically confirmed diagnosis of localized GIST with documented KIT (CD117) positivity (by polyclonal DAKO antibody staining)
    I3.Documented macroscopically complete surgical R0 or R1 resection of primary GIST lesion with no evidence of residual lesions or metastases on the baseline CT-scan or MRI performed no more than 4 weeks before randomization.
    I4.Risk of tumor recurrence ≥35% according to National Comprehensive Cancer Network Task Force on GIST (NCCN) risk classification (Demetri et al., 2010) (adapted from Miettinen and Lasota, Seminars in Diagnostic Pathology 2006: 23(2) 70-83)
    I5.ECOG performance status 0, 1 or 2
    I6.Patients must be under imatinib treatment (at 300 or 400mg/day) initiated immediately after resection and maintained for 3 years (i.e. 36 months ± 3 months at the time of randomization) with no more than 3 consecutive months or 6 months in total of interruption during these 3 years.
    I7.Patients must have normal organ and bone marrow function at baseline as defined below:
    •Adequate bone marrow function as defined by: ANC ≥ 1.5 x 109/L, platelet count ≥ 100.0 x 109/L, and haemoglobin of ≥ 9 g/dL).
    •Adequate liver function, as determined by: Serum total bilirubin ≤ 1.5 ULN, AST and ALT ≤ 3 x ULN (or 5ULN in case of hepatic metastases at time of reintroduction)
    •Adequate renal function assessed by at least one of the following:
    1) Serum creatinine ≤ 1.5 x ULN or
    2) creatinine clearance estimate ≥ 50 mL/min (as calculated according to Cockcroft-Gault formula or MDRD formula for patients > 65 years).
    I8.Recovered from prior anti-neoplasic treatment-related toxicity (persistent treatment-related toxicity < Grade 2 as per CTCAE v4 are accepted)
    I9.Women of childbearing potential* are required to have a negative serum pregnancy test within 72 hours prior to randomization. A positive urine test must be confirmed by a serum pregnancy test
    I10.Patient must use two forms of effective contraception (refer to Appendix 3 for acceptable method of contraception) at least 4 weeks prior to study entry, during the study participation and for at least 30 days post-treatment (not applicable for women of non-childbearing potential)
    I11.Ability to understand and willingness for follow-up visits.
    I12.Covered by a medical insurance.
    I13.Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
    I1.Age ≥ 18 ans le jour de la signature du consentement
    I2.Confirmation histologique du diagnostic de GIST avec mutation documentée de KIT (CD117) (par marquage avec l’anticorps polyclonal DAKO A4502)
    I3.Résection macroscopique complète de type R0 ou R1 de la tumeur primaire sans lésion résiduelle ou métastase apparente clairement documentée sur un scanner ou IRM réalisé dans les 4 semaines précédant la randomisation
    I4.Risque de récidive ≥ 35% selon la classification du NCCN (Demetri et al., 2010) ou élevé selon la classification de Joensuu
    I5.PS ECOG ≤ 2
    I6.Traitement par imatinib (300 mg ou 400 mg/jour) initié après la chirurgie et maintenu pendant 3 ans (c.a.d 36 mois +/- 3 mois au moment de la randomisation), sans interruption de plus de 6 mois consécutifs ou 9 mois au total au cours de ces 3 années
    I7.Paramètres biologiques conformes aux valeurs suivantes :
    •Fonctionnement adéquat de la moelle osseuse, défini par : neutrophiles ≥ 1,5 x 109/L, plaquettes ≥ 100 x 109/L et hémoglobine ≥ 9 g/dl
    •Fonctionnement adéquat de la fonction hépatique défini par : bilirubine totale ≤ 1.5 LNS, AST et ALT ≤ 3LNS
    •Fonctionnement adéquat de la fonction rénale évalué par au minimum un des paramètres suivants :
    1)Créatininémie ≤ 1.5 LNS ou
    2)Clairance de la créatinine ≥ 50 mL/min (calculée avec la formule de Cockcroft-Gault ou la formule MDRD pour les patients âgés de plus de 65 ans)
    I8.Ayant récupéré des toxicités liées aux traitements anti-néoplasiques antérieurs (les toxicités persistantes de grade < 2 selon la classification CTCAE v4 sont acceptées)
    I9.Les femmes en âge de procréer doivent avoir un test de grossesse sérique négatif dans les 72 heures précédant la randomisation. Un test urinaire positif doit être confirmé par un test sérique
    I10.Acceptant d’utiliser 2 méthodes de contraception efficaces (cf. annexe 3 pour les méthodes acceptées) à partir de 4 semaines avant l’entrée dans l’étude, pendant toute la durée de l’étude et jusqu’à 1 mois après la dernière prise d’imatinib (non applicable pour les femmes n’étant pas en âge de procréer)
    I11.Capable de comprendre les informations transmises et volonté de se complier aux visites prévues dans le cadre de l’étude
    I12.Affilié(e) à un régime de sécurité sociale
    I13.Ayant daté et signé un consentement éclairé indiquant que le patient a été informé de tous les aspects de l’étude avant l’inclusion
    E.4Principal exclusion criteria
    E1. Pregnant or breastfeeding women
    E2. Patient concurrently using other approved or investigational antineoplastic agents
    E3. Any contra-indication to imatinib treatment as per Glivec® SPC
    E4. Patient with GIST harboring the mutation ; PDGFRa d842V
    E5. Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient’s participation in this trial or would likely interfere with study procedures or results
    E6. Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years
    E7. Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications
    E8. Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
    E9. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection
    E10. Major surgery within 2 weeks prior to study entry
    E.1. Femme enceinte ou allaitante
    E.2. Patient recevant un autre médicament anticancéreux autorisé ou en cours d’investigation
    E.3. Patient présentant une contre-indication à l’imatinib définie dans le RCP de l’imatinib
    E.4. Patient atteint d’un GIST présentant la mutation PDGFRa d842V
    E.5. Maladie concomitante affectant le système cardiovasculaire, le foie, les reins, le système hématopoïétique ou tout autre organe et jugée cliniquement significative par l’investigateur et incompatible avec la participation du patient à l’étude ou pouvant interférer avec les procédures ou les résultats de l’étude
    E.6. Antécédent de pathologie maligne autre que le GIST (à l’exception d’un carcinome basocellulaire ou épidermoïde ou d’un carcinome in situ du col) sauf si le patient est en rémission complète depuis au moins 3 ans
    E.7. Patient recevant un traitement concurrent contenant de la warfarine (alternative acceptable : héparine de bas poids moléculaire) ou tout autre traitement concurrent/concomitant interdit
    E.8. Patient présentant une pathologie cardiaque de grade III/IV selon les critères de la NYHA (insuffisance cardiaque congestive, infection myocardique dans les 6 mois précédant l’inclusion, etc.)
    E.9. Infection VIH connue
    E.10. Chirurgie majeure dans les 15 jours précédant l’inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Disease-Free survival
    Survie sans maladie
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years post-randomization
    3 ans post-randomisation
    E.5.2Secondary end point(s)
    Overall survival
    Time to second resistance
    Percentage of patients in complete response
    Quality of life
    Survie globale
    Délai jusqu'à résistance secondaire
    Pourcentage de patients en réponse complète
    Qualité de vie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival, time to second resistance, percentage of patients in complete response : 3 years post-randomization
    Quality of life : baseline, 1, 2 and 3 years post-randomization and in case of progression
    Survie globale, délai jusqu'à résistance secondaire, pourcentage de patients en réponse complète : 3 ans post-randomisation
    Qualité de vie : inclusion, 1, 2 et 3 ans post-randomisation et en cas de récidive
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Qualité de vie
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Pas de traitement. En cas de récidive, les patients recevront de l'imatinib.
    No treatment. In case of recurrence, imatinib will be introduced.
    E.8.2.4Number of treatment arms in the trial2
    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 concerned12
    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 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
    Dernière visite du dernier patient randomisé
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 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.1.2.1Number of subjects for this age range: 256
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 256
    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 state256
    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)
    None
    Aucun
    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 Decision2014-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-12-07
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