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   43857   clinical trials with a EudraCT protocol, of which   7284   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:2018-001295-37
    Sponsor's Protocol Code Number:CILOGIST
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-08-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-001295-37
    A.3Full title of the trial
    CILOSTAZOL AS IMATINIB SYNERGISER IN PATIENTS WITH UNRESECTABLE OR METASTATIC GIST TREATED BY GLIVEC®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adjunction of cilostazol to imatinib for patients with an unresectable or metastatic GIST (Gatsrointestinal stromal tumor) already treated by imatinib or who will start a treatment with imatinib
    Association du cilostazol à l’imatinib pour le traitement des GIST (GastroIntestinal Stromal Tumor) non résécables et ou métastatiques nécessitant un traitement par imatinib ou déjà traités par imatinib
    A.3.2Name or abbreviated title of the trial where available
    CILOGIST
    A.4.1Sponsor's protocol code numberCILOGIST
    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 SponsorCUB HOPITAL ERASME
    B.1.3.4CountryBelgium
    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 supportCUB HOPITAL ERASME
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCUB HOPITAL ERASME
    B.5.2Functional name of contact pointDEMOLS Anne
    B.5.3 Address:
    B.5.3.1Street AddressRoute de Lennik 808
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.4Telephone number3225553712
    B.5.5Fax number3225558236
    B.5.6E-mailanne.demols@erasme.ulb.ac.be
    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 Pletal
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePletal
    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 INNCILOSTAZOL
    D.3.9.1CAS number 73963-72-1
    D.3.9.2Current sponsor code201-476-4
    D.3.9.4EV Substance CodeSUB06273MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code EMEA/H/C/000406
    D.3.4Pharmaceutical form Capsule, hard
    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 codeEMEA/H/C/000406
    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 typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 tumors.

    Gastrointestinal stromal tumors (GISTs) start their development in special cells in the wall of the gastrointestinal (GI) tract, also known as the digestive tract.
    E.1.1.1Medical condition in easily understood language
    Gastrointestinal stromal tumors.
    Gastrointestinal stromal tumors (GISTs) start their development in special cells in the wall of the gastrointestinal (GI) tract, also known as the digestive tract.
    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 aims of this study are to confirm pre-clinical data and to evaluate the potential synergism between Glivec® and cilostazol in patient with unresectable or metastatic GIST of any primary (except PDGFR&D842V mutants), and also to evaluate the tolerability and safety of the combined therapy.

    Primary objective:
    Evaluation of metabolic response on 18F-FDG PET using EORTC (PET Study Group) Criteria after 28 days of cilostazol treatment added to Glivec®
    Image will be analysed by 2 independant nuclear specialists
    Results will be statistically analysed by using the Wilcoxon rank test for paired observations.
    Tolerability and safety of the combination therapy


    E.2.2Secondary objectives of the trial
    Evaluation of morphological response on thoraco-abdominal CT Scan using the radiological Choi Criteria based on the modifications of the size and/or tumor density (Hounsfeild Unit) of the lesions.
    Search of possible predictive factor of therapeutic response using statistical analysis by the Cox multivariate regression method
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    -histologically proven metastatic or locally advanced histologically proven non resectable GIST ( any primary tumor site) already treated by Glivec® (at any dose) for at least 12 months in first line therapy, or patients who will start Glivec® (at any dose) in first line therapy or after failure of all TKIs
    -exon 11, exon 9 or other kit mutations
    -written signed informed consent
    -ability to take oral medication
    -metabolic positivity of the tumor at the first PET-CT (positivity is defined as High 18F-FDG uptake by a lesion more than the surrounding tissue)
    -at least one measurable lesion by CT scanner
    -no contraindication to cilostazol
    -ECOG performance status 0 /1 at study entry
    -effective contraception for both male and female patients must be used for at least 8 weeks after the last study drug administration if the risk of conception exists
    -age > 18 years old
    -life expectancy at least 12 weeks
    - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
    o Serum creatinine <1.5x upper reference range
    o Total bilirubin <1.5x ULN
    o Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5x ULN (<5x ULN for patients with liver involvement of their cancer).
    o Amylase and lipase <1.5x ULN.
    o INR<1.5x ULN

    E.4Principal exclusion criteria
    Exclusion Criteria:
    -PDGFR&D842V mutation
    -Wild-type tumors
    -unability to take oral medication
    -any malabsorption condition
    -previous exposure to cilostazol or PDE3 inhibitor or any other phosphodiesterase inhibitor
    -known hypersensitivity to any of the components of study treatments
    -previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
    -pregnancy or breast feeding
    -medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
    -patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study
    - history of organ allograft
    -ongoing infection HIV infection
    -liver failure, cirrhosis Child Pugh B or C
    -active chronic hepatitis B or C with a need for antiviral treatment
    -heart failure any NYHA class
    -grapefruit juice consumption
    -hemodialysis
    -active bleeding disorder or coagulation disorder
    -uncontrolled concurrent CNS, cardiac, infectious diseases

    E.5 End points
    E.5.1Primary end point(s)
    -Evaluation of metabolic response on 18F-FDG PET using EORTC (PET Study Group) Criteria after 28 days of cilostazol treatment added to Glivec®
    Image will be analysed by 2 independants nuclear specialists
    Results will be statistically analysed by using the Wilcoxon rank test for paired observations.
    -Tolerability and safety of the combination therapy (evaluated using EORTC criteria, CTCAE version 4.0 for toxicity)

    E.5.1.1Timepoint(s) of evaluation of this end point
    -Evaluation of metabolic response on 18F-FDG PET using EORTC (PET Study Group) Criteria after 28 days of cilostazol treatment added to Glivec®
    Image will be analysed by 2 independants nuclear specialists
    Results will be statistically analysed by using the Wilcoxon rank test for paired observations.
    -Tolerability and safety of the combination therapy (evaluated using EORTC criteria, CTCAE version 4.0 for toxicity)

    E.5.2Secondary end point(s)
    -Evaluation of morphological response on thoraco-abdominal CT Scan using the radiological Choi Criteria based on the modifications of the size and/or tumor density (Hounsfeild Unit) of the lesions.
    -Search of possible predictive factor of therapeutic response using statistical analysis by the Cox multivariate regression method


    E.5.2.1Timepoint(s) of evaluation of this end point
    PET-CT scan at 28days under combination therapy imatinib (Glivec) and cilostazol (Pletal) started at day 56.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 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.8.6 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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state10
    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)
    Not different
    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 Decision2018-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-02-10
    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-Thu Apr 25 00:40:46 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA