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    Summary
    EudraCT Number:2012-004103-12
    Sponsor's Protocol Code Number:ISOTOVE
    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:2013-06-11
    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 number2012-004103-12
    A.3Full title of the trial
    ISOTOVE study
    Isotopic study of the intraperitoneal distribution of locoregional post surgery chemotherapy for peritoneal carcinomatosis of ovarian origin
    Etude ISOTOVE
    Etude isotopique de la distribution intrapéritonéale d’une chimiothérapie loco-régionale post-opératoire pour carcinose péritonéale d’origine ovarienne
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ISOTOVE study
    Isotopic study of the intraperitoneal distribution of locoregional post surgery chemotherapy for peritoneal carcinomatosis of ovarian origin
    Etude ISOTOVE
    Etude isotopique de la distribution intrapéritonéale d’une chimiothérapie loco-régionale post-opératoire pour carcinose péritonéale d’origine ovarienne
    A.4.1Sponsor's protocol code numberISOTOVE
    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 Jean Perrin
    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 Jean Perrin
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Jean Perrin
    B.5.2Functional name of contact pointClinical Trial Informations
    B.5.3 Address:
    B.5.3.1Street Address58, rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63011
    B.5.3.4CountryFrance
    B.5.4Telephone number33473278491
    B.5.5Fax number33473278410
    B.5.6E-mailCatherine.ABRIAL@cjp.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 Nanocis, trousse pour la préparation de la solution injectable de sulfure de rhénium colloidal et de technetium (nanocolloide)
    D.2.1.1.2Name of the Marketing Authorisation holderCIS BIO INTERNATIONAL
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal 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 Yes
    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
    peritoneal carcinomatosis of ovarian origin
    carcinose péritonéale d’origine ovarienne
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    Cancer de l'ovaire
    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
    -Evaluate the anatomical distribution of the isotope imaging at the time of administration of intraperitoneal chemotherapy
    -Evaluer la diffusion anatomique par imagerie du produit isotopique au moment de l’administration des cures de chimiothérapie intra-péritonéale
    E.2.2Secondary objectives of the trial
    -Assess tolerance to treatment based on the diffusion
    -Describe the sites of intraperitoneal relapse depending on the product distribution
    -Evaluer la tolérance au traitement en fonction de la diffusion
    -Décrire les sites de rechutes intra-péritonéales en fonction de la diffusion du produit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age> 18 years.
    -Performance status 0-2
    - ANC> 1.5.109 / L (without the addition of GCSF)
    -Platelets> 100. 109 / L
    -Bilirubin <or equal to 1.5 times the upper normal value (VNS)
    -AST and ALT <or equal to 2.5 upper normal value
    Alkaline-Phosphatase <or equal to 2.5 upper normal value
    - Creatinine <or equal to 2.0 mg / deciliter
    -PTT <1.5 times the upper normal value (heparin, or other anticoagulants lovenox accepted)
    -PT/INR <Or equal to 1.5 upper normal value (VNS) (or INR between 2 and 3, if the patient receives a dose stabilized Warfarin)
    - Patient operated first line without macroscopic residue for ovarian cancer or primary peritoneal or tubal stage IIIC peritoneal or pleural IV
    -Minimum required for surgery: hysterectomy, bilateral salpingo-oophorectomy, omentectomy and pelvic lymphadenectomy para-aortic
    - Patient requiring adjuvant chemotherapy
    - Compulsory affiliation to a social security scheme.
    - Obtaining informed consent in writing, signed and dated.
    - Age > 18 ans.
    -Performance status 0-2
    - PNN > 1.5.109 /L, (sans apport de GCSF)
    -Plaquettes > 100. 109 /L
    -Bilirubine < ou égal à 1.5 fois la valeur normale supérieure (VNS)
    -ASAT et ALAT < ou égal à 2,5 valeur normale supérieure (VNS)
    -Phosphatase alkaline < ou égal à 2,5 valeur normale supérieure (VNS)
    - Créatinine < ou égal à 2.0 mg/décilitres
    -PTT < 1.5 fois la valeur normale supérieure (VNS) (héparine, lovenox ou autres anticoagulants acceptés)
    -PT/INR < ou égal à 1,5 valeur normale supérieure (VNS) (ou INR compris entre 2 et 3, si la patiente reçoit une dose stabilisée de Warfarine)
    - Patiente opérée de première intention sans résidu macroscopique pour cancer de l’ovaire ou tubaire ou péritonéal primitif de stade IIIC péritonéal ou IV pleural
    -Minimum requis pour la chirurgie : hystérectomie, annexectomie bilatérale, omentectomie et curage pelvien lomboaortique
    - Patiente nécessitant un traitement adjuvant par chimiothérapie
    - Affiliation obligatoire à un régime de sécurité sociale.
    - Obtention du consentement éclairé écrit, signé et daté.
    E.4Principal exclusion criteria
    -Patient aged 70 years and over
    - Patient with cognitive or psychiatric conditions.
    - Patient deprived of liberty by a court or administrative order.
    - Patient with indications against the realization of chemotherapy
    - Concomitant treatment with a drug test, participation in another therapeutic clinical trial < 30 days
    - Pregnant Women
    - Breastfeeding
    Sensory neuropathy, motor or > grade 1 (CTCAE)
    -Hepatitis or severe infection requiring parenteral antibiotics
    - Serious non-healing wound or ulcer, or bone fracture
    -Abdominal fistula or gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to intraperitoneal chemotherapy
    -Clinical symptoms or signs of gastrointestinal obstruction and / or require hydration and / or parenteral nutrition
    -Patients who have had or are currently having an inflammatory disease of the bowel
    - Active bleeding or pathological condition that carries a high risk of bleeding (eg, bleeding disorders known coagulopathy, or tumor with large vessels)
    - Stroke (CVA) or transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
    - Cardiovascular disease clinically significant, including:
    o Uncontrolled hypertension, defined as systolic blood pressure> 150 mm Hg or diastolic> 90 mm Hg
    o myocardial infarction or unstable angina within the past 6 months
    o NYHA class II-IV congestive heart failure
    o serious cardiac arrhythmia requiring treatment:
    -Asymptomatic atrial fibrillation with controlled ventricular or supraventricular tachycardia controlled with medication and is authorized asymptomatic
    o Peripheral vascular disease ≥ grade 2 (CTCAE) (short [less than 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)

    -History hemorrhage or cerebral vascular accident (CVA), transient ischemic attack, or subarachnoid in the last 6 months

    -Major surgery within 28 days before enrollment
    -Patiente âgée de 70 ans et plus
    - Patiente présentant des troubles cognitifs ou psychiatriques.
    - Patiente privée de liberté par décision de justice ou administrative.
    - Patiente ayant des contre indications à la réalisation de la chimiothérapie
    - Traitement concomitant par un médicament en essai, participation à un autre essai clinique thérapeutique dans un délai < 30 jours
    - Femmes enceintes
    - Femmes allaitantes
    -Neuropathies sensorielles ni motrices > grade 1 (CTCAE)
    -Hépatite ou infection sévère nécessitant des antibiotiques par voie parentérale
    - Grave non-cicatrisation de plaie, ou ulcère, ou fracture osseuse
    -Fistule abdominale, ou perforation gastro-intestinale, ou abcès intra abdominale au cours des 28 jours précédents la chimiothérapie intra péritonéale
    -Symptômes cliniques, ou signes gastrointestinaux d’obstruction et /ou qui nécessiteraient une hydratation et / ou une nutrition parentérale
    -Patientes ayant eu ou ayant actuellement une maladie inflammatoire de l’intestin
    - Saignement actif ou état pathologique qui entraîne un risque élevé de saignement (par exemple, troubles de la coagulation connus, coagulopathie, ou tumeur avec de gros vaisseaux)
    - Accident vasculaire cérébral (AVC), ou accident ischémique transitoire, ou hémorragie méningée au cours des 6 derniers mois
    - Maladie cardio-vasculaire cliniquement significative, y compris:
    o hypertension non contrôlée, définie comme la pression artérielle systolique> 150 mm Hg ou diastolique> 90 mm Hg
    o infarctus du myocarde ou un angor instable au cours des 6 derniers mois
    o classe NYHA II-IV d'insuffisance cardiaque congestive
    o arythmie cardiaque grave nécessitant un traitement :
    -une fibrillation auriculaire asymptomatique avec fréquence ventriculaire contrôlée ou une tachycardie supraventriculaire contrôlée avec prise de médicaments et asymptomatique est autorisée
    o maladie vasculaire périphérique ≥ grade 2 (CTCAE) (brefs [moins de 24 heures] épisodes d'ischémie gérés de façon non-chirurgicale et sans déficit permanent)

    -Antécédents hémorragie ou accident vasculaire cérébral (AVC), accident ischémique transitoire, ou sous-arachnoïdienne dans les 6 derniers mois

    -Chirurgie majeure dans les 28 jours précédant l’inclusion
    E.5 End points
    E.5.1Primary end point(s)
    - Quantify and localise anomalies in the peritoneal cavity fixing
    - Quantifier et localiser les anomalies de fixation dans la cavité péritonéale
    E.5.1.1Timepoint(s) of evaluation of this end point
    the assessment will be realised during the chemotherapy
    l'évaluation sera réalisée en cours de chimiothérapie
    E.5.2Secondary end point(s)
    - Correlate the intensity of binding to the location of the pain in the peritoneal cavity
    - Correlate the degree of pain intensity setting in the peritoneal cavity
    - Correlate sites relapse localization uptake abnormalities in the peritoneal cavity
    - Corréler l’intensité de fixation à la localisation de la douleur dans la cavité péritonéale
    - Corréler l’intensité de la douleur à l’intensité de la fixation dans la cavité péritonéale
    - Corréler les sites de rechutes à la localisation des anomalies de fixation dans la cavité péritonéale
    E.5.2.1Timepoint(s) of evaluation of this end point
    the assessment will be realised during the chemotherapy and until 5 years after chemotherapy for the relapses
    l'évaluation sera réalisée en cours de chimiothérapie et jusqu'à 5 ans après la chimiothérapie pour les rechutes
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Anatomical diffusion of the isotope by imaging
    Diffusion anatomique par imagerie de l'isotope
    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 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
    The end of the study corresponds to the end of the follow up period for the last patient of the trial.
    La fin de l'étude correspond à la fin de la période de suivi de la dernière patiente encore dans l'étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state20
    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
    Aucun
    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 Decision2013-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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