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    Summary
    EudraCT Number:2016-003774-40
    Sponsor's Protocol Code Number:TheStopGISTtrial
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-05-18
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-003774-40
    A.3Full title of the trial
    Discontinuation of imatinib in patients with oligo-metastatic gastrointestinal stromal tumor that has become radiologically undetectable with treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Discontinuation of imatinib in patients with oligo-metastatic gastrointestinal stromal tumor that has become radiologically undetectable with treatment
    A.3.2Name or abbreviated title of the trial where available
    The stop-GIST trial
    A.4.1Sponsor's protocol code numberTheStopGISTtrial
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportUnifor-Frimed
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointØyvind Sverre Bruland
    B.5.3 Address:
    B.5.3.1Street AddressUllernchausseen 70
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0379
    B.5.3.4CountryNorway
    B.5.4Telephone number4722934000
    B.5.6E-mailOSB@ous-hf.no
    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 (imatinib)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    Gastrointestinal stromal tumour (GIST)
    E.1.1.1Medical condition in easily understood language
    Gastrointestinal stromal tumour (GIST)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10051066
    E.1.2Term Gastrointestinal stromal tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to document progression-free survival (PFS) in patients who discontinue imatinib after treatment with imatinib for longer than 5 years for oligo-metastatic GIST (≤ 3 metastases) and who have no detectable overt GIST lesions in CT/MRI imaging following complete surgical resection (R0/R1-resection), radiofrequency ablation (RFA) of the metastases, or following systemic treatment for oligometastatic GIST
    E.2.2Secondary objectives of the trial
    The secondary objectives are to study overall survival and the quality of life (QoL) in the patients who discontinue imatinib. Data about response to reinstitution of imatinib after GIST progression will be collected from the hospital records from those patients who restarted imatinib after completion of the study.

    The exploratory objectives are to study the relationship between study endpoints and circulating biomarkers, relationships between study endpoints and biomarkers in resected tumors prior to study entry, and changes in the blood cell counts and blood biochemistry after stopping imatinib as compared to the baseline values on imatinib, measured at the time of the screening examinations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18.
    2. Morphological and immunohistochemical documentation of GIST (immunostaining for KIT/(CD117) and/or DOG-1 (anoctamin-1)) must be positive on a tumour sample. Patients with demonstrated mutation in KIT or PDGFRA may be entered to the study despite negative immunostaining for KIT and DOG-1 provided that tumour histology is compatible with GIST.
    3. >5.0 years of treatment with imatinib for metastatic disease when the breaks in imatinib administration are taken into account.
    4. No more than 3 detectable metastases in the liver and/or in the abdomen in imaging of the abdomen and the pelvis during the course of the disease or at surgery.
    5. Confirmed metastatic GIST in history by radiology, histology, or both.
    6. Macroscopically complete resection of all metastases (either R0 or R1 surgery). Patients who have microscopically infiltrated margins (or suspected microscopical infiltration, R1) are allowed to enter the study. RFA of liver metastasis is allowed in place of surgery. Patients whose oligometastatic disease had disappeared completely so that no remaining target lesion for surgery or RFA can be identified (including absence of residual cyst-like lesions) are allowed to enter the study.
    7. Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2.
    8. Patient has provided a written, voluntary informed consent prior to study entry and any study-specific procedures.
    E.4Principal exclusion criteria
    1. Patients with metastases outside of the abdomen (e.g. in the bones or lungs).
    2. Not willing to donate tumor tissue and/or blood samples for the molecular studies that aim at predicting of GIST recurrence.
    3. Presence of an SDH mutation or other evidence for SDH deficiency.
    4. Presence of neurofibromatosis-1.
    5. R2 resection of the primary tumor or metastasis.
    6. Patient with inability to grant reliable informed consent.
    7. Inability to comply with the scheduled follow-up.
    8. Progressive disease during imatinib or other systemic treatments for GIST, or before or after surgery/RFA of the metastases.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The PFS will be measured from the date of discontinuation of imatinib to the date of first documentation of progression or death (from any cause), whichever occurs first.

    1-year PFS in the first 15 patients included. The study is terminated if 10 or more of the 15 patients (≥67 %) have progression of disease or withdraws from the study within the first 12 months from the date of study entry.

    The final analysis will be performed when the patients without an event have a median follow-up time of above 36 months
    E.5.2Secondary end point(s)
    Overall Survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival will be measured from the date of discontinuation of imatinib to the dato of death resulting from any cause.

    The final analysis will be performed when the patients without an event have a median follow-up time of above 36 months
    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 No
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA4
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 10
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 21
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 31
    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)
    Follow-up according to regular clinical practice
    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 Decision2017-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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