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    Summary
    EudraCT Number:2018-003994-80
    Sponsor's Protocol Code Number:ET18-270
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-25
    Trial results View 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 number2018-003994-80
    A.3Full title of the trial
    A Phase II study evaluating AGuIX® nanoparticles in combination with Stereotactic Radiation for oligo brain metastases
    Etude de phase II évaluant les nanoparticules AGUIX® en combinaison avec la radiothérapie stéréotaxique pour le traitement des oligo-métastases cérébrales.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating AGuIX® nanoparticles in combination with radiotherapy for brain metastases.
    Etude évaluant la combinaison des nanoparticules Aguix avec la radiothérapie pour le traitement des métastases cérébrales.
    A.3.2Name or abbreviated title of the trial where available
    Nanostéréo
    Nanostéréo
    A.4.1Sponsor's protocol code numberET18-270
    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 Léon Bérard
    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 supportNH Theraguix
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address28 rue Laennec
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69008
    B.5.3.4CountryFrance
    B.5.4Telephone number+334 78 78 27 96
    B.5.5Fax number+334 69 85 61 82
    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 No
    D.2.1.1.1Trade name AGUIX
    D.2.1.1.2Name of the Marketing Authorisation holderAGUIX
    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 nameAGUIX
    D.3.4Pharmaceutical form Lyophilisate for 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
    Brain metastases
    Métastases cérébrales
    E.1.1.1Medical condition in easily understood language
    Brain Tumor
    Tumeur au cerveau
    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 LLT
    E.1.2Classification code 10006128
    E.1.2Term Brain metastases
    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 evaluate the clinical impact of AGuIX® nanoparticles in combination with Stereotactic Radiation in oligo brain metastases.
    Evaluer l’impact clinique des nanoparticules d’AGUIXd’AGuIX® en combinaison avec la radiothérapie stéréotaxique sur les oligo-métastases cérébrales.
    E.2.2Secondary objectives of the trial
    To further evaluate the clinical activity of AGuIX® nanoparticles in combination with Stereotactic Radiation in oligo brain metastases.
    To assess the impact of the proposed therapeutic strategy on patient quality of life (QoL) and cognition.
    To assess the safety of the proposed therapeutic strategy.
    Evaluer l’activité clinique des nanoparticules d’AGUIX® en combinaison avec la radiothérapie stéréotaxique sur les oligo-métastases cérébrales.
    Evaluer l'impact de la combinaison proposée sur la qualité de vie de la
    population cible et la cognition.
    Evaluer la sécurité de la stratégie thérapeutique proposée.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1. Male or female patients aged of at least 18 years on day of signing informed consent.
    I2. Histologically-confirmed diagnosis of any histological type of solid tumors, excluding primary Central nervous system (CNS) tumors.
    I3. Radiological evidence by MRI :
    - At least one and a maximum of 5 brain metastases, and
    - At least one brain lesion with a longest diameter ≥ 2 cm and eligible for FSRT.
    I4. Patient without progression on extracranial disease documented by radiological assessment as per RECIST v1.1 within 4 weeks before inclusion.
    I5. For patients treated with a systemic anti-cancer therapy: a minimal 2-week washout period is required from the date of last systemic treatment administration to Day 1, except for hormonal agents.
    I6. ECOG Performance Status (PS) ≤2 .
    I1. Homme ou femme âgé(e) d’au moins 18 ans à la date de signature du consentement.
    I2. Diagnostic confirmé par un examen histologique de tout type de tumeur solide à l’exception des tumeurs primitives du système nerveux central.
    I3. Examen radiologique confirmant la présence d’ (par IRM):
    - Au moins 1 à 5 (maximum) métastases cérébrales, et
    - au moins une lésion dont le plus grand diamètre est ≥ 2 cm et éligible à la radiothérapie stéréotaxique fractionnée.
    I4. Patient sans progression extra-crânienne documentée par un examen radiologique selon les critères RECIST 1.1 dans les 4 semaines avant l’inclusion.
    I5. Pour les patients traités par une thérapie systémique pour leur cancer, une période minimal sans traitement de 2 semaines est requis (période entre la dernière prise et la thérapie et le Jour 1).
    I6. Statut de performance (PS) selon l’échelle ECOG (Eastern Cooperative Oncology Group) ≤2
    E.4Principal exclusion criteria
    E1. Prior local treatment with radiotherapy (whole / partial brain or stereotactic radiosurgery) or surgical resection of brain lesions.
    E2. Patient participating to another clinical trial with an investigational agent.
    E3. Patients who have not recovered from significant adverse events (i.e. Grade > 2 AE according to NCI CTCAE v5.0, see Appendix 4) due to prior treatment with anti-cancer agents with exception of any Grade alopecia or lab values presented in criteria I7.
    E4. Contra-indication for MRI enhanced with gadolinium (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants).
    E5. Patients who are pregnant or breastfeeding.
    E1. Patients ayant déjà était traité pour des métastases cérébrales par radiothérapie (complète ou partielle) ou par chirurgie.
    E2. Patients participant à un autre essai clinique avec un médicament expérimental.
    E3. Patients présentant une toxicité persistante de Grade >2 selon la classification NCI CTCAE V5.0 relatif à des traitements anti-cancéreux antérieurs, à l'exception de l'alopécie, des neuropathies et des valeurs biologiques définies dans les critères d’inclusion.
    E4. Patients présentant une contre-indication à l’IRM avec Gadolinium (pacemaker, défibrillateur, certaines valves cardiaques, certains implants métalliques).
    E5. Patientes enceintes ou allaitantes.

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the rate of local control
    Le critère d'évaluation principale est le taux de contrôle de la maladie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 an
    E.5.2Secondary end point(s)
    - Distant brain failure
    - Time to brain relapse.
    - Tumor target volume agreement (MRI comparisons) between D4 AGuIX®-MRI and D1 Initial screening T1-Gd-Chelate-MRI
    - Variation of brain lesion volume at Day 45 and 3 months after the start of treatment.
    - MRI evaluation of contrast enhancement at D4 after AGuIX® injection
    - Overall survival.
    - Rechute cérébrale à distance ,
    - Délai jusqu’à la rechute locale,
    - Comparaison du Volume de la lésion cible entre Jour 1 et Jour 4,
    - Variation du volume tumorale à Jour 45 et à 3 mois après le début de la radiothérapie,
    - Evaluation de la prise de contraste à Jour 4 après l’injection d’AGuIX®,
    - Survie globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Distant brain failure at 6 months and 1 year
    Rechute cérébrale à distance à 6 mois et 1 an après le début du traitement
    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 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 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 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 concerned2
    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
    LVLP
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 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 state55
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-02-22
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