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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2015-004108-44
    Sponsor's Protocol Code Number:PREMETHEP
    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:2016-03-14
    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 number2015-004108-44
    A.3Full title of the trial
    PREMETHEP : Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an early predictive factor of overall survival in patients with advanced hepatocellular carcinoma treated with sorafenib.
    Caractérisation multi-métabolique par Tomographie par Emission de Positons (TEP) au 18F-Fluorodésoxyglucose (FDG) et à la 18F-Fluorocholine (FCH) pour prédire la survie des patients présentant un carcinome hépatocellulaire avancé traité par Sorafenib.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PREMETHEP : Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an early predictive factor of overall survival in patients with advanced hepatocellular carcinoma treated with sorafenib.
    Caractérisation multi-métabolique par Tomographie par Emission de Positons (TEP) au 18F-Fluorodésoxyglucose (FDG) et à la 18F-Fluorocholine (FCH) pour prédire la survie des patients présentant un carcinome hépatocellulaire avancé traité par Sorafenib.
    A.3.2Name or abbreviated title of the trial where available
    PREMETHEP
    PREMETHEP
    A.4.1Sponsor's protocol code numberPREMETHEP
    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 Georges-François Leclerc
    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 supportCentre George-François Leclerc
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre george François Leclerc
    B.5.2Functional name of contact pointREDERSTORFF Emilie
    B.5.3 Address:
    B.5.3.1Street Address1 rue du Pr Marion
    B.5.3.2Town/ cityDijon
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number+3303 80 73 75 003461
    B.5.5Fax number+330380 73 77 53
    B.5.6E-mailERederstorff@cgfl.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 18F-Fluorodésoxyglucose (FDG)
    D.2.1.1.2Name of the Marketing Authorisation holderADVANCED ACCELERATOR APPLICATIONS SA (AAA)
    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 nameGLUSCAN 600 MBq/mL®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.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 18F-Fluorocholine (FCH)
    D.2.1.1.2Name of the Marketing Authorisation holderIASON GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameIASOcholine®1 GBq/mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    Hepatocellular carcinoma (HCC) is the 3rd cause of death by cancer. For patients with inoperable advanced HCC, systemic therapy with Sorafenib (Nexavar®) is the only therapeutic with proven survival benefits. However, the efficacy of Sorafenib remains inconstant and the overall incidence of treatment-related adverse event is 80%.
    Le carcinome hépatocellulaire (CHC) est la 3ème cause de décès par cancer. Pour les formes inopérables avancées de CHC, le Sorafenib (Nexavar®) est le seul traitement systémique apportant un gain significatif en terme de survie. Cependant, l'efficacité de ce traitement est inconstante au prix de nombreux effets secondaires constatés chez environ 80% des patients.
    E.1.1.1Medical condition in easily understood language
    Hepatocellular carcinoma (HCC) is the 3rd cause of death by cancer.
    Le carcinome hépatocellulaire (CHC) est la 3ème cause de décès par cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine in a prospective multicenter study, the predictive performances on 1-year overall survival (Sensitivity, specificity, positive and negative predictive values and threshold) of lipid and glucose metabolism and perfusion changes determined with FCH and FDG PET after 4 weeks of Sorafenib therapy.
    Evaluer les capacités prédictives sur la survie à un an des modifications précoces des métabolismes glucidique et lipidique et de la perfusion tumorale déterminés par TEP/TDM au FDG et TEP/TDM au FCH après 4 semaines de traitement par sorafenib chez des patients présentant un carcinome hépato-cellulaire avancé (stade C de la classification BCLC).
    E.2.2Secondary objectives of the trial
    a) To determine the independent prognostic factors of overall survival.
    b) To identify the predictive performances and the optimal threshold of changes in FDG and FCH uptake after 4 weeks of Sorafenib therapy regarding disease control.
    c) To identify the predictive performances and thresholds of baseline FDG and FCH tumour uptakes regarding survival and disease control.
    d) To identify the best combination of metabolic parameters (FCH and FDG baseline uptake and changes) that is predictive of 1-year overall survival.
    e) To describe quality of life (QoL) using the EORTC QLQ-C30 (version 3.0) at each clinical surveillance visit.
    a) Déterminer les facteurs prédictifs indépendants de la survie globale.

    b) Déterminer si les changements précoces de la captation tumorale de FDG et de FCH sont prédictifs du contrôle tumoral radiologique (évalué à partir de 4 mois, par scanner ou IRM).

    c) Déterminer si l’intensité initiale (avant traitement) de la captation tumorale de FCH et FDG est prédictive du contrôle tumoral radiologique et de la survie à un an.

    d) Identifier la meilleure combinaison de paramètres métaboliques (captation tumorale de FCH et de FDG, initiale et après un mois de traitement), permettant de prédire la survie à un an.

    e) Evaluer la qualité de vie des participants.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients older than 18 years.
    - Inoperable (advanced or metastatic) HCC histologically proven, or diagnosed according to the Barcelona criteria, determined to be candidate for Sorafenib therapy.
    - Lesion(s) able to be selected as target lesion(s) for modified RECIST criteria.
    - Patient ineligible for curative treatment (BCLC score B or C).
    - Child-Pugh liver function class A.
    - No obvious contraindication for Sorafenib.
    - Adequate hematologic function (platelet count ≥60.109/l; hemoglobin ≥8.5 g/dl; INR ≤2.3).
    - ECOG status ≤2.
    - Able to lie still for 45 min for PET/CT scanning.
    - Able to understand and willing to sign a written informed consent document.
    - Affiliated to the "Sécurité Sociale" or beneficiary to such a regimen
    - Homme et femme
    - Age ≥18 ans
    - Carcinome hépatocellulaire prouvé histologiquement ou diagnostiqué selon les critères de l’AASLD.
    - Patient avec un CHC avancé selon les critères de Barcelone (stade C), avec ou sans envahissement portal, chez qui un traitement par sorafenib est indiqué.
    - Lésion(s) sélectionnable(s) comme lésion(s) cible(s) selon les critères mRECIST (lésion mesurable selon les critères RECIST, accessible à des mesures répétées, se réhaussant après injection d’agent de contraste en TDM ou IRM).
    - Patient inéligible pour un traitement curatif (transplantation hépatique ou résection chirurgicale).
    - Pas de contre-indication au sorafenib
    - Fonction hépatique conservée (Child-Pugh A)
    - Fonction hématologique adéquate : hémoglobine ≥ 8,5g/100mL, plaquettes ≥ 60.109/L, INR ≤ 2,3.
    - Patient capable de rester en décubitus dorsal pendant au moins 30 minutes.
    - Consentement écrit.
    - Patient affilié à un régime de sécurité sociale ou ayant droit.
    E.4Principal exclusion criteria
    - Uncontrolled intercurrent illness with short-term life-threatning.
    - Patient candidate to local/curative therapies of HCC (surgery, radiofrequency, transarterial chemoembolization, other local therapy).
    - Pregnant or nursing woman.
    - History of myocardial infarction less than 6 months before inclusion, uncontrolled hypertension, symptomatic congestive heart failure, anti-arythmic therapy (other than beta-blockers or digoxine).
    - History of digestive bleeding less than 30 days before inclusion.
    - History of liver transplantation.
    - Previous treatment including Sorafenib.
    - Uncontrolled diabetes.
    - History of allergic reactions attributed to compounds of similar chemical or biological composition to 18F-Fluorocholine, 18F-Fluorodeoxyglucose or Sorafenib.
    - Psychiatric illness/social situations that would limit compliance with the study requirements.
    - Pathologie intercurrente non contrôlée avec espérance de vie inférieure à 6 mois.
    - Femme enceinte ou allaitant.
    - Patient candidat à un traitement local et/ou curatif (chirurgie, radiofréquence, chimioembolisation, autre traitement local).
    - Antécédent, dans les 6 mois précédent l’inclusion, d’infarctus myocardique, ou hypertension non contrôlée, ou insuffisance cardiaque congestive symptomatique, ou traitement par anti-arythmique (autre que béta-bloquant ou digoxine).
    - Hémorragie digestive dans les 30 jours précédant l’inclusion.
    - Antécédent de transplantation hépatique.
    - Patient ayant déjà reçu un traitement par sorafenib.
    - Diabète non contrôlé.
    - Antécédent de réaction allergique attribué au 18F-fluorodésoxyglucose, à la 18F-fluorocholine, ou au sorafenib.
    - Maladie psychiatrique ou autre désordre psychologique nuisant au consentement éclairé.
    - Patient incapable de suivre un traitement oral.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is vital status (death or alive)
    Statut vital (vivant ou décédé)
    E.5.1.1Timepoint(s) of evaluation of this end point
    one year after inclusion
    un an après l’inclusion.
    E.5.2Secondary end point(s)
    - Overall survival

    - Disease Control defined by absence of radiologic progression according to modified RECIST (mRECIST) criteria (24)

    - Quality of life, described using the EORTC QLQ-C30 (version 3.0)
    - Survie globale

    - Contrôle tumoral radiologique, défini comme l’absence de progression radiologique selon les critères RECIST modifiés (mRECIST),

    - Qualité de vie, évaluée selon le questionnaire EORTC QLQ-C30 (version 3.0) (Annexe 1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - defined as survival between inclusion and death whatever the cause.

    - during at least 4 months following beginning of Sorafenib therapy.

    - Completed at inclusion and at each clinical surveillance visit.
    - définie comme la survie entre l’inclusion et le décès quelle que soit la cause

    - pendant au moins 4 mois suivant le début du traitement par sorafenib.

    - rempli à l’inclusion et à chaque visite de surveillance
    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 No
    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 No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    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
    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: 87
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 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 state87
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 87
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-15
    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-Mon Apr 29 11:59:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA