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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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).

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    Summary
    EudraCT Number:2021-001430-19
    Sponsor's Protocol Code Number:ET21-084
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-18
    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 number2021-001430-19
    A.3Full title of the trial
    GIST-TEN: Randomized, prospective, multicentre, open label phase II study evaluating the interest of imatinib (Glivec) treatment maintenance or interruption after at least 10 years of treatment in patients with locally advanced/metastatic Gastrointestinal Stromal Tumors (GISTs)
    GIST-TEN : Étude de Phase II, prospective, randomisée, multicentrique, en ouvert, évaluant l’intérêt d’interrompre ou de maintenir l’imatinib (Glivec®) chez les patients ayant une tumeur gastro-intestinale stromale (GIST) localement avancée/métastatique après 10 ans de traitement
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating the interest of imatinib treatment maintenance or interruption after at least 10 years of treatment in patients with locally Advanced or metastatic Gastrointestinal Stromal Tumors
    Étude évaluant l’intérêt d’interrompre ou de maintenir l’imatinib chez les patients ayant une tumeur gastro-intestinale stromale localement avancée ou métastatique après 10 ans de traitement
    A.3.2Name or abbreviated title of the trial where available
    GIST-TEN
    GIST-TEN
    A.4.1Sponsor's protocol code numberET21-084
    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 Sponsor Centre Léon 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 Léon BERARD
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address28 rue laennec
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69373
    B.5.3.4CountryFrance
    B.5.4Telephone number003304 78 78 27 86
    B.5.5Fax number003304 78 78 27 15
    B.5.6E-mailseverine.metzger@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 AuthorisationIreland
    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 Coated 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
    D.3.9.1CAS number 152459-95-5
    D.3.9.3Other descriptive nameIMATINIB
    D.3.9.4EV Substance CodeSUB25387
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number300 to 800
    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
    locally advanced or metastatic Gastrointestinal Stromal Tumors
    tumeur gastro-intestinale stromale localement avancée ou métastatique
    E.1.1.1Medical condition in easily understood language
    Gastrointestinal Stromal Tumors
    tumeur gastro-intestinale stromale
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    to compare the 6-month progression-free rate (PFR-6m) between interruption versus maintenance of imatinib treatment in patients with an advanced/metastatic GIST controlled after 10 years of imatinib treatment.
    Comparer le taux de survie sans progression à 6 mois (PFR-6m) entre la poursuite et l’arrêt de l’imatinib chez des patients présentant un GIST localement avancé ou métastatique stable après 10 ans de traitement par imatinib.
    E.2.2Secondary objectives of the trial
    To compare between the 2 arms:
    •the progression free survival (PFS);
    •the overall survival (OS);
    •the safety;
    •the Quality of Life (QoL).

    In the interruption arm only:
    To determine in the subgroup of patients who progressed:
    •the Progression-Free Survival rechallenge (PFS rechallenge);
    •the Objective Response Rate;
    •the duration of response (DOR) after imatinib reintroduction;
    Comparer entre les 2 bras:
    •La survie sans progression (PFS)
    •La survie globale (OS)
    •La tolérance
    •La qualité de vie (QoL).

    Dans le bras d’arrêt seulement :
    Déterminer dans le sous-groupe des patients ayant progressés :
    •La survie sans progression (PFS2)
    •La taux de réponse objective (ORR)
    •La durée de réponse (DOR) après réintroduction de l’imatinib
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational research will be conducted to identify the genomic (WES) expression profile (RNAseq) and immunologic characteristics of potentially cured patients.
    Une recherche translationnelle sera réalisée pour identifier le profil d’expression génomique (WES) par RNAseq et les caractéristiques immunologiques des patients potentiellement guéris.
    E.3Principal inclusion criteria
    I1.Patients ≥ 18 years of age;
    I2.Histologically documented diagnosis of malignant advanced/metastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;
    I3.ECOG Performance status (PS) 0, 1, 2;
    I4.Patient must be under imatinib treatment (at 300 or 400mg/day) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period;
    I5.Patient with controlled disease (without any progression under imatinib);
    I6.Ability to understand and willingness for follow-up visits;
    I7.Covered by a medical insurance;
    I8.Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
    I1.Patients ≥ 18 ans ;
    I2.Patient porteur d’un GIST localement avancé ou métastatique histologiquement prouvé avec documentation immunohistochimique de l’expression C Kit (CD177+) dans la tumeur primaire ou les métastases.
    I3.ECOG Performance status (PS) 0, 1, 2 ;
    I4.Le patient doit être sous traitement par imatinib (à 300 ou 400 mg/jour) pendant 10 ans ou plus, sans interruption de plus de 12 mois au total ou 3 mois consécutifs pendant la période de traitement ;
    I5.Patient présentant une maladie contrôlée et n’ayant jamais progressé sous imatinib ;
    I6.Volonté et capacité de se conformer au calendrier des visites ;
    I7.Patient affilié à un régime de sécurité sociale ;
    I8.Patient ayant daté et signé un consentement éclairé indiquant qu’il a été informé de tous les aspects de l’étude.
    E.4Principal exclusion criteria
    NI1.Patient concurrently using other approved or investigational antineoplastic agents;
    NI2.Patient with GIST harboring the mutation D842V in PDGFRA ;
    NI3.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;
    NI4.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) or or patient without residual disease for at least the last 3 years;
    NI5.Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and/or concurrent medications;
    NI6.Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;
    NI7.Major surgery within 2 weeks prior to study entry;.
    NI8.Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;.
    NI9.Pregnant or breastfeeding women;
    NI10.Patient requiring tutorship or curatorship or patient deprivied of liberty.
    NI1.Patient recevant un autre agent anticancéreux approuvé ou en cours d’investigation ;
    NI2.Patient ayant un GIST portant la mutation D842V du gène PDGFRA ;
    NI3.Patient ayant des maladies concomitantes majeures pouvant affecter le système cardiovasculaire, le foie, les reins, le système hématopoïétique ou toute autre maladie considérée comme cliniquement importante par l'investigateur qui pourrait être incompatible avec la participation du patient à cet essai ou qui pourrait interférer avec les procédures ou les résultats de l'étude ;
    NI4.Antécédent d’autres maladies malignes autres que celui de l’étude (hormis les carcinomes squameux et basocellulaire de la peau ou les carcinomes in situ du col utérin) ou patients sans résidu tumoral les 3 dernières années ;
    NI5.Patient recevant un traitement concomitant par warfarin (alternative acceptable : héparines de faibles poids moléculaires) ou tout médicament interdit et/ou concomitant ;
    NI6.Patient positif pour l’infection VIH ;
    NI7.Patient ayant subi une chirurgie majeure dans les 2 semaines précédant l’entrée dans l’étude.
    NI8.Troubles psychiatriques ou de toxicomanie connus qui ne respecteraient pas aux exigences de l’étude.
    NI9.Femme enceinte ou allaitante ;
    NI10.Patient sous tutelle ou curatelle ou patient privé de liberté
    E.5 End points
    E.5.1Primary end point(s)
    the progression-free rate at 6 months (PFR-6m) expressed in each arm by the rate of patients with a non-progressive disease 6 months after randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after randomization.
    E.5.2Secondary end point(s)
    -PFS will be defined as the time from the date of randomization to the date of the first documented progression, or date of death due to any cause. Patients with no event at the time of the analysis will be censored at the date of last available tumor assessment.
    -OS will be defined as the time from the date of randomization to the date of death due to any cause.
    -The safety will be determined through the incidence of treatment emergent adverse events (TEAE), serious adverse Events (SAE) and death. Tolerance will be assessed using the NCI-CTC AE v5 grading scale.
    -QoL will be assessed using the EORTC QLQ-C30 questionnaire.
    -PFS rechallenge will be defined as the time from the date of imatinib reintroduction in the experimental arm to the date of subsequent progression, or date of death due to any cause. Patients with no event at the time of the analysis will be censored at the the date of last available tumor assessment.
    -ORR after imatinib reintroduction will be defined as the proportion of patients with a best overall response of Partial Response (PR) or Complete Response (CR) after imatinib reintroduction
    -The duration of response to imatinib after reintroduction will be defined as the time from the date of first objective response following the reintroduction of imatinib to the date of the first subsequent documented radiological progression or death and censored at the date of last available tumor assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    A la fin de l'étude
    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 No
    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 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 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 Yes
    E.8.2.3.1Comparator description
    maintenance of Imatinib
    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 concerned13
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months60
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    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)
    At the physician's discretion
    A la discrétion du médecin
    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 Decision2021-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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