Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-005255-87
    Sponsor's Protocol Code Number:2014-13
    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:2015-06-19
    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 number2014-005255-87
    A.3Full title of the trial
    Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index. Multicenter, prospective, randomized study.
    Evaluation de l’efficacité d’un traitement adjuvant par Imatinib chez les patients porteurs d’une tumeur stromale gastro-intestinale de risque intermédiaire présentant un Genomic Index de mauvais pronostic. Etude multicentrique, prospective, randomisée.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index. Multicenter, prospective, randomized study.
    Evaluation de l’efficacité d’un traitement adjuvant par Imatinib chez les patients porteurs d’une tumeur stromale gastro-intestinale de risque intermédiaire présentant un Genomic Index de mauvais pronostic. Etude multicentrique, prospective, randomisée.
    A.3.2Name or abbreviated title of the trial where available
    GI-GIST
    GI-GIST
    A.4.1Sponsor's protocol code number2014-13
    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 SponsorAssistance Publique Hôpitaux de MARSEILLE
    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 supportPHRC Cancer 2013
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique Hôpitaux de MARSEILLE
    B.5.2Functional name of contact pointDESALBRES Urielle
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche 80 Rue Brochier
    B.5.3.2Town/ cityMarseille CEDEX 05
    B.5.3.3Post code133545
    B.5.3.4CountryFrance
    B.5.4Telephone number+33491 38 27 47
    B.5.5Fax number+33491 38 14 79
    B.5.6E-mailpatrick.sudour@ap-hm.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 nameGlivec
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeIMATINIB
    D.3.9.3Other descriptive nameIMATINIB
    D.3.9.4EV Substance CodeSUB25387
    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
    Patients with intermediate-risk gastrointestinal stromal tumor presenting a high Genomic Grade Index
    Patient présentant une tumeur stromale gastrointestinale de risuqe intermédaire avec un index génomique élevé
    E.1.1.1Medical condition in easily understood language
    Patients with intermediate-risk gastrointestinal stromal tumor presenting a high Genomic Grade Index
    Patient présentant une tumeur stromale gastrointestinale de risuqe intermédaire avec un index génomique élevé
    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
    The primary objective of this study is to assess the efficacy of adjuvant Imatinib on rate of metastatic relapse at 2 years in patients with intermediate-risk gastrointestinal stromal tumor presenting a high Genomic Grade Index.
    L'objectif principal de cette étude est d'évaluer l'efficacité de l'Imatinib en adjuvant sur le taux de rechute métastatique à 2 ans chez des patients de risque intermédiaire selon la classification de Miettenen et don le Genomic index est de mauvais pronostic.
    E.2.2Secondary objectives of the trial
    The second objectives of this study are to compare the two therapeutic approaches in terms of:
    - Metastasis-free survival at 1 year, 2 years and 3 years
    - Overall survival
    - Clinical and biological tolerance, safety
    - Quality of life of patients and caregivers
    Les objectifs secondaires de cette étude sont de comparer ces deux approches thérapeutiques en terme de :
    - Survie sans métastase à 1 an, 2 ans et 3 ans
    - Survie globale
    - Tolérance clinique et biologique, toxicité
    - Qualité de vie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject with no prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy
    - Subject with a Performance Status between 0-2
    - Subject with a gastrointestinal stromal tumor, intermediary risk from the Armed Forces Institute of
    Pathology classification [Miettenen 2006]
    - Subject with Genomic Grade Index higher than 10 determined by CGH array;
    - Subject with surgery for primary tumor performed from 2 weeks to 2 months before starting adjuvant Imatinib mesylate;
    - Subject with no evidence of residual macroscopic disease after surgery (RO). Microscopically infiltrated margins, or supposed to be are allowed (R1)
    - Subjects with absence of distant metastases
    - Sujets n'ayant eu aucune radiothérapie antérieure, aucune chimiothérapie antérieure, aucune thérapie ciblée
    - Subject présentant un Performance Status compris entre 0 et 2
    - Sujet avec une tumeur stromale gastro-intestinale de risque intermédiaire selon la classification de Miettenen
    - Sujet présentant un Genomic Index ≥10 déterminé par CGH array;
    - Sujet avec une chirurgie de la tumeur réalisée dans les 2 semaines à 2 mois avant le début du traitement par Imatinib adjuvant;
    - Sujet ayant beneficié d’une chirurgie RO ou R1
    - Sujets non métastatiques
    E.4Principal exclusion criteria
    - Subject under 18 years old or pregnant or breast-feeding women.
    - Subject with a contraindication to Imatinib, a known hypersensitivity to the active substance or to any of
    the excipients (ambivalence clause);
    - Subject treated with medicinal products that induce CYP3A4;
    - Subject who have experienced spontaneous tumor rupture before surgery (risk of spread);
    - Subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from tumor block;
    - Subject whose mutational status meets the wild phenotype definition as evidenced by sequencing from tumor block;
    - Sujet mineurs ou femmes enceintes ou allaitantes.
    - Sujet avec une contre-indication à l’Imatinib, une hypersensibilité connue à la substance active ou à n'importe lequel de ces excipients;
    - Sujet traité avec des médicaments inducteur du CYP3A4;
    - Sujet ayant présenté une rupture tumorale spontanée en préopératoire (risque de dissémination);
    - Sujet dont la tumeur a une mutation PDGFRA D842V;
    - Sujet dont la tumeur présente un statut mutationel de phénotype sauvage;
    E.5 End points
    E.5.1Primary end point(s)
    The primary criterion is the efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan. The rate of metastatic relapse at two years will be defined by the percentage of patients developing thoraco-abdominal and pelvic metastases on CT scan. Computed tomography scan with contrast (chest, abdomen and pelvis plus other areas as appropriate) will be used for assessment of metastasis. The same diagnosis method must be used throughout the study to evaluate diagnose a metastatic
    Le critère principal de jugement est le taux de rechute métastatique à 2 ans à partir des données issues des scanners thoraco-abdominaux et pelviens.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 ans
    E.5.2Secondary end point(s)
     Secondary efficacy endpoints
    Efficacy will be complemented by 1-year, 2-year and 3-year metastasis-free survival based on a thoraco-abdominal and pelvic CT-scan using the same procedure as detailed below.
    Metastasis-free survival will be defined as the time from the baseline visit (feedback of the randomization to the patient) and the earliest date of documented radiological occurrence of metastasis.

     Overall survival
    Overall survival will be defined as the time from baseline evaluation (randomization) until death due to any cause (linked or not to the disease).

     Clinical and biological tolerance
    Safety and tolerance will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC) at 15 days, 1 month and every three months. The investigator will grade all adverse events and severe adverse events (defined by the standard medical dictionary for regulatory activities, MedDRA) according to the NCI-CTCAE (version 4.0). Adverse events will be grouped by system organ classes.

     Patients’ quality of life
    The quality of life of the subject will be assessed by means of 2 questionnaires:
    - A generic questionnaire: the French version of the SF36 [Leplège 1998]. This standardized questionnaire validated for the French population comprises 36 items that are used to calculate eight scale scores (physical functioning, social functioning, role–physical, role–emotional, mental health, vitality, bodily pain and general health). Two composite summary measures can also be calculated; the Physical Component Summary and the Mental Component Summary scores. SF36 yield scores on a 0–100 scale (0 = low QoL; 100 = high QoL). French reference values are available.
    - A specific questionnaire, the French version of the EORTC QLQ-C30. EORTC QLQ-C30, assesses the quality of life of cancer patients. It is a 30-item questionnaire comprised of five functional scales (physical, role, emotional, cognitive, social), nine symptom scales and single-symptom items, and a global health status scale. The scores for each scale/item range from 0 to 100. A high score on a functional scale represents a high/healthy level of functioning, a high score on the global health status scale represents a high quality of life, but a high score on a symptom scale represents a high level of symptomatology. Among instruments the most widely used at the international level to measure cancer-related quality of life, the EORTC QLQ-C30 presents satisfactory metrological properties [Sprangers 1998, Cull 1998].
    L'efficacité de l'Imatinib en adjuvant sur le taux de rechute métastatique sera étudie à 1 an-2 ans et 3 ans à partir des données issues des scanners thoraco-abdominaux et pelviens. pour une survie sans métastase à 1 an, 2 ans et 3 ans
    La Survie globale sera étudié entre la randomisation et jusqu'au déces liés ou non à la pathologie
    Tolérance clinique et biologique, toxicité: la tolérance et la sécurité seront évaluées à partir des criteres CTCAE et CTC à 15 jour , 1 mois puis tous les 3 mois. L'investigateur quotera les évènements indésirables et les évènements indésirables graves selon la version 4.0 du NCI-CTCAE. Les évènement indésirable seront classés par classes d'organes

    La qualité de vie des sujets sera mesurée a l'aide de 2 auto-questionnaires: le SF36 en version française et l'auto-questionnaire EORTC QLQ-C30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    3 ans
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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
    Sans médicament
    No medical product
    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 concerned18
    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 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
    the last visit of the last subject undergoing the trial will be the end of the study
    La dernière visite du dernier sujet inclus dans l'étude
    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 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state80
    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
    Non
    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 Decision2015-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-04
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 12:40:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA