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    Summary
    EudraCT Number:2014-000050-10
    Sponsor's Protocol Code Number:FFCD1307
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-21
    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 number2014-000050-10
    A.3Full title of the trial
    Chemoembolisation of patient with hepatocellular carcinoma, not selective for a curative treatment, by microsphere charged with idarubicin
    Chimioembolisation des carcinomes hépatocellulaires ne relevant pas d'un traitement curatif, par billes chargées en idarubicine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    patient with advanced hepatic cancer treated by microsphere charged with chemotherapie (idarubicine)
    Patient présentant un cancer du foie avancé, traité par microbilles chargée avec une molécule de chimiothérapie type idarubicine.
    A.3.2Name or abbreviated title of the trial where available
    IDASPHERE II
    IDASPHERE II
    A.4.1Sponsor's protocol code numberFFCD1307
    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 SponsorFédération Francophone de Cancérologie Digestive
    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 supportBiocompatibles UK Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFédération Francophone de cancérologie Digestive
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street AddressFaculté de médecine, 7 boulevard Jeanne d'Arc, BP 87900
    B.5.3.2Town/ cityDIJON Cedex
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number33380393404
    B.5.5Fax number33380381841
    B.5.6E-mailmarie.moreau@u-bourgogne.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 ZAVEDOS (chlorydrate d'idarubicine)
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    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 nameZAVEDOS
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameIDARUBICIN
    D.3.9.4EV Substance CodeSUB08111MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 hepatocellular carcinoma, not selected for curative treatment
    Les patients doivent présenter un carcinome hépatocellulaire ne relevant pas d'un traitement curatif
    E.1.1.1Medical condition in easily understood language
    patient with hepatic cancer who can't receive a curative treatment
    Patient ayant un cancer du foie, ne pouvant pas recevoir un traitement curatif
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10059318
    E.1.2Term Hepatic cancer stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10059324
    E.1.2Term Hepatic cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10059319
    E.1.2Term Hepatic cancer stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10059330
    E.1.2Term Hepatic cancer stage IIIA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10059334
    E.1.2Term Hepatic cancer stage IVA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10059332
    E.1.2Term Hepatic cancer stage IVB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10059331
    E.1.2Term Hepatic cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10073069
    E.1.2Term Hepatic cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective response rate (complete and partial response) according to mRECIST at 6 months assessed in central review
    Taux de réponse objective (réponse complète et partielle) selon le mRECIST à 6 mois évalué en relecture centralisée
    E.2.2Secondary objectives of the trial
    Objective response rate (mRECIST) at 6 months assessed by the investigator
    Objective response rate at 6 months according to the EASL [European Association for the Study of the Liver] criteria
    Time to treatment failure
    Better response according to the mRECIST criteria
    Survival without progress
    Overall survival
    Treatment tolerance
    Quality of life
    Taux de réponse objective (mRECIST) à 6 mois évalué par l’investigateur
    Taux de réponse objective à 6 mois selon les critères EASL
    Temps jusqu’à échec du traitement
    Meilleure réponse selon les critères mRECIST
    Survie sans progression
    Survie globale
    Tolérance du traitement
    Qualité de vie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically proven HCC or according to the EASL criteria
    - Preserved liver function (in case of Child-Pugh A or B7 cirrhosis)
    - Tumour not subject to interventive care (liver transplant, surgical resection or percutaneous destruction) BCLC A/B without portal or extra-hepatic invasion
    - Measurable targets based on the mRECIST v1.1 criteria
    - No prior treatment by chemotherapy, radiotherapy or transarterial embolisation (with or without chemotherapy)
    - Age ≥ 18 years
    - WHO 0 or 1
    - Laboratory test: platelets ≥50,000/mm3, N ≥ 1,000/mm3, creatininaemia ≤ 150 µmol/L
    - No heart failure (isotope or ultrasound VEF > 50%)
    - Signed informed consent
    - CHC prouvé histologiquement ou selon les critères EASL/Barcelone pour les nodules > à 1 cm
    - Tumeur ne relevant pas d’un traitement à visée curative (transplantation hépatique, résection chirurgicale ou destruction percutanée)
    - Cibles mesurables selon les critères mRECIST v1.1
    - Fonction hépatique préservée (en cas de cirrhose, Child-Pugh A ou B7 sans antécédents de décompensation œdèmo-ascitique)
    - Tumeur classée BCLC A ou B sans envahissement portal ou extra-hépatique ou C si OMS = 1
    - Pas de traitement préalable par chimiothérapie, radiothérapie ou embolisation transartérielle (avec ou sans chimiothérapie)
    - Age ≥ 18 ans
    - OMS 0 ou 1
    - Bilan biologique : plaquettes ≥ 50 000/mm3, PNN ≥ 1 000/mm3, créatininémie ≤ 150 µmol/L
    - Pas d’insuffisance cardiaque (FEV isotopique ou échographique > 50%)
    - Consentement éclairé signé
    E.4Principal exclusion criteria
    - Advanced tumour (vascular or extra-hepatic invasion including brain metastasis or diffuse HCC with liver invasion > 50%)
    - History of other type of cancer except cancer known to be in remission for more than 3 years (in this case, HCC histological proof is required), or basal-cell carcinoma or in situ cervix uteri cancer properly treated with curative treatment
    - Previous treatment by idarubicin and/or doxorubicin
    - Idarubicin contraindications (cardiopathy with myocardial failure, serious kidney or liver failure, yellow fever vaccine)
    - Concurrent disease or uncontrolled severe clinical condition
    - Long-term anticoagulant treatment
    - Thrombosis of the portal vein or a 3-segment region or more
    Hepatofugal portal venous flow
    Presence of serious atheromatosis
    Presence of collateral vessel pathways potentially endangering normal territories during embolisation
    Presence of arthritis of the hepatic artery branches to be treated
    Presence of arterioportal or arterial subhepatic fistula that cannot be embolised by coils
    - Pregnancy or breastfeeding
    - Absence of effective contraception (for men and women of childbearing age)
    - Patient who cannot be regularly monitored on account of psychological, social, family- or geography-related reasons
    - Concomitant participation of a patient in another study
    - Maladie tumorale avancée (invasion vasculaire ou extrahépatique dont métastases cérébrales ou CHC diffus avec un envahissement du foie > 50%)
    - Antécédent d’autre cancer à l’exclusion de cancers reconnus comme guéris depuis plus de 3 ans (dans ce cas une preuve histologique du CHC est nécessaire), ou de tumeurs cutanées basocellulaires ou du cancer du col de l’utérus in situ traités de façon adéquate et à visée curative
    - Traitement antérieur par idarubicine et/ou doxorubicine
    - Contre-indications à l’idarubicine (cardiopathie avec insuffisance myocardique, insuffisance rénale ou hépatique grave, vaccin anti-amarile (fièvre jaune))
    - Maladie concomitante ou situation clinique sévère non contrôlée
    - Patient nécessitant un traitement anticoagulant au long cours
    - Thrombose du tronc porte ou d’un territoire de 3 segments ou plus (ou flux hépatofuge des mêmes territoires)
    - Atteinte vasculaire :
    atteinte athéromateuse grave ou,
    voies vasculaires collatérales mettant potentiellement en danger les territoires normaux pendant l’embolisation ou,
    artérite des branches de l’artère hépatique à traiter ou,
    fistule artério-porte ou artério-sus-hépatique non embolisable par des coils
    - Grossesse ou allaitement
    - Absence de contraception efficace (pour les hommes ou les femmes en âge de procréer)
    - Patient qui pour des raisons psychologiques, sociales, familiales ou géographiques ne pourrait pas être suivi régulièrement
    - Participation concomitante du patient à une autre expérimentation
    E.5 End points
    E.5.1Primary end point(s)
    Reviewing of the 6 month MRI by an independant radiolgist
    Relecture des IRM à 6 mois par un radiologue indépendant.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month after the last inclusion
    6 mois après le dernier patient inclus dans l'étude
    E.5.2Secondary end point(s)
    Objective response rate (mRECIST) at 6 months assessed by the investigator: evaluation of the treatment response on MRI at 6 month after inclusion assessed by investigator
    Objective response rate at 6 months according to the EASL [European Association for the Study of the Liver] criteria: evaluation of tratment response on MRI at 6 month after inclusion according to the EASL criteria(by investigator and by independant radiologist after the last inclusion)
    Time to treatment failure : time between inclusion and no effective treatment (death, progression)
    Better response according to the mRECIST criteria: evaluation on MRI of the better response during the 6 month treatment
    Survival without progress: time between inclusion and date of progression for each patient included
    Overall survival : time between inclusion and date of death or date of last new for patients always survival at the moment of analys
    Treatment tolerance: evaluation of toxicity during treatment
    Quality of life: evaluation of score of questionnary QLQ-C30 et HCC-18
    Taux de réponse objective (mRECIST) à 6 mois évalué par l’investigateur: évaluation sur IRM durant les 6 mois de la réponse au traitement
    Taux de réponse objective à 6 mois selon les critères EASL: évaluation de la réponse au traitement sur les IRM durant les 6 mois suivant les critères EASL
    Temps jusqu’à échec du traitement: temps jusqu'à la date où l'on constate que le traitement n'est plus efficace
    Meilleure réponse selon les critères mRECIST: évaluation de la meilleure réponse durant le traitement (sur IRM)
    Survie sans progression: évaluation de la date de progression chez chaque patient inclus
    Survie globale: évaluation de la date de décès ou la date de dernière nouvelles si les patients sont toujours vivants
    Tolérance du traitement: évaluation des toxicités selon le NCI- CTC v4.0 durant le traitement de l'étude
    Qualité de vie: évaluation des scores sur les questionnaires de qualité de vie QLQ-C30 et HCC-18
    E.5.2.1Timepoint(s) of evaluation of this end point
    Objective response rate (mRECIST) at 6 months assessed by the investigator: 6 month after the last inclusion
    Objective response rate at 6 months according to the EASL [European Association for the Study of the Liver] criteria: 6 month after the last inclusion
    Time to treatment failure : 6 month after the last inclusion
    Better response according to the mRECIST criteria: 6 month after the last inclusion
    Survival without progress: 2 years after the last inclusion
    Overall survival : 2 years after the last inclusion
    Treatment tolerance: 6 month after the last inclusion
    Quality of life: 6 month after the last inclusion
    Taux de réponse objective (mRECIST) à 6 mois évalué par l’investigateur: évaluation sur IRM durant les 6 mois de la réponse au traitement
    Taux de réponse objective à 6 mois selon les critères EASL: 6 mois après l'inclusion du patient
    Temps jusqu’à échec du traitement: 6 mois après l'inclusion du patient
    Meilleure réponse selon les critères mRECIST: 6 mois après l'inclusion du patient
    Survie sans progression: 2 ans après l'inclusion du dernier patient
    Survie globale: 2 ans après l'inclusion du dernier patient
    Tolérance du traitement: 6 mois après l'inclusion du patient
    Qualité de vie: 6 mois après l'inclusion du patient
    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 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 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 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 concerned10
    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
    The end of study corresponding at the last visit at 2 years for the last patient onging in the study
    La fin de l'étude correspond à la visite à 2 ans du dernier patient en cours dans l'étude.
    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
    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: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state91
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 91
    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
    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 Decision2014-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-31
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