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    Summary
    EudraCT Number:2020-004552-15
    Sponsor's Protocol Code Number:NANO-GBM
    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:2020-12-02
    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 number2020-004552-15
    A.3Full title of the trial
    Phase I/II study of AGuIX nanoparticles with radiotherapy plus concomitant Temozolomide in the treatment of newly diagnosed glioblastoma
    Etude de phase I/II testant l’association de nanoparticules AGuIX, à une radio-chimiothérapie avec témozolomide concomitant chez des patients présentant un glioblastome nouvellement diagnostiqué
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II study of AGuIX nanoparticles with radiotherapy plus Temozolomide in the treatment of glioblastoma
    Etude de phase I/II testant l’association de nanoparticules AGuIX, à une radio-chimiothérapie avec témozolomide chez des patients présentant un glioblastome
    A.4.1Sponsor's protocol code numberNANO-GBM
    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 supportDGOS (PHRC-I AURA 2019)
    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 pointDivision de Recherche Clinique
    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 numberFranc473278089
    B.5.5Fax numberFranc473278029
    B.5.6E-mailemilie.THIVAT@clermont.unicancer.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 No
    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 nameGadolinium-chelated polysiloxane nanoparticles
    D.3.2Product code AGuIX
    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 Yes
    D.3.11.13.1Other medicinal product typenanoparticles
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 temozolomide
    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 nametemozolomide
    D.3.4Pharmaceutical form Capsule
    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.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 250
    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
    glioblastoma
    glioblastome
    E.1.1.1Medical condition in easily understood language
    glioblastoma is a type of brain tumor
    le glioblastome est un type de tumeur cérébrale
    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 PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    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
    - Phase I: to determine the recommended dose of AGuIX in combination with radiotherapy and TMZ during the concomitant radiochemotherapy period
    - Phase II: to estimate the efficacy of the combination radiochemotherapy + AGuIX (recommended dose), measured by the 6-month progression-free survival rate
    - Phase I : déterminer la dose recommandée AGuIX en combinaison avec la radiothérapie et le TMZ pendant la période radio-chimiothérapie concomitante
    - Phase II : estimer l’efficacité de l’association radio-chimiothérapie + AGuIX (dose recommandée), mesurée par le taux de survie sans progression à 6 mois

    E.2.2Secondary objectives of the trial
    - To evaluate the pharmacokinetics of nanoparticles (phase I)
    - To evaluate the distribution of nanoparticles and the sparing of healthy tissues
    - To evaluate the safety of the combination: acute (<90 days) and late toxicity as well as changes in the dose and schedule of radiotherapy (phase I / II)
    - To evaluate the impact of the combination on efficacy: measured by overall survival at 6 months and 12 months, response to treatment and progression-free survival at 12 months (phase II)
    - To study the potential predictive biomarkers and exploration of the tumor microenvironment
    - Evaluer la pharmacocinétique des nanoparticules (phase I)
    - Evaluer la distribution des nanoparticules et l’épargne des tissus sains
    - Evaluer la tolérance de l’association : toxicité aigüe (< 90 jours) et tardive ainsi que les modifications de dose et d’étalement de la radiothérapie (phase I/II)
    - Evaluer l’impact de l’association sur l’efficacité : mesurée par la survie globale à 6 mois et à 12 mois, la réponse au traitement et la survie sans progression à 12 mois (phase II)
    - Etudier les biomarqueurs prédictifs potentiels et l'exploration du microenvironnement tumoral
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histological diagnosis of grade IV glioblastoma (biopsy or partial surgery)
    - Patient not operated on or partial resection
    - KPS ≥ 70%
    - Age ≥ 18 years old and <75 years old
    - Life expectancy ≥ 6 months
    - Platelets ≥ 100,000 / mm3
    - PNN ≥ 2000 / mm3
    - Hb ≥ 10 g / L
    - Creatinine <1.5 times the upper normal limit or clearance according to Cockcroft-Gault ≥ 50 mL / min
    - Liver function (GGT, PAL, ASAT, ALAT, bilirubin) <1.5 times the upper normal limit
    - For patients receiving treatment with corticosteroids, treatment with corticosteroids must be at a stable or decreasing dose for at least 14 days before inclusion
    - Patient able to swallow and retain oral medication
    - Negative serum pregnancy test within 7 days before the first administration of treatment for women
    - Women of childbearing potential and men whose partners are of childbearing potential must agree to use, themselves or their partners, an approved method of contraception throughout the treatment and at least 6 months after the last administration of study treatment.
    - Obtaining signed informed consent from the patient
    - Patient affiliated to a social security regimen
    - Diagnostic histologique de glioblastome grade IV (biopsie ou chirurgie partielle)
    - Patient non opéré ou en exérèse partielle
    - KPS ≥ 70%
    - Âge ≥ 18 ans et < 75 ans
    - Espérance de vie ≥ 6 mois
    - Plaquettes ≥ 100 000/mm3
    - PNN ≥ 2000/mm3
    - Hb ≥ 10 g/L
    - Créatinine < 1,5 fois la limite supérieure normale ou clairance selon Cockcroft-Gault ≥ 50 mL/min
    - Fonction hépatique (GGT, PAL, ASAT, ALAT, bilirubine) < 1,5 fois la limite supérieure normale
    - Pour les patients recevant un traitement par corticoïdes, le traitement par corticoïdes doit être à une dose stable ou décroissante depuis au moins 14 jours avant l’inclusion
    - Patient capable d’avaler et de garder un traitement par voie orale
    - Test de grossesse sérique négatif dans les 7 jours avant la première administration du traitement pour les femmes
    - Les femmes en âge de procréer et les hommes dont les partenaires sont en âge de procréer doivent accepter d’utiliser, eux-mêmes ou leurs partenaires, une méthode de contraception approuvée pendant toute la durée du traitement et au moins 6 mois après la dernière prise du traitement à l’étude.
    - Obtention du consentement éclairé signé du patient
    - Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    -prior brain radiotherapy
    -prior chemotherapy (including implants containing carmustine (Gliadel®) or immunotherapy (vaccination included)
    -Any contraindication to TMZ listed in the SPCs
    -History of major intestinal resection which may modify the absorption of oral drugs according to the judgment of the investigator
    -Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis)
    -Diarrhea ≥ grade 2 CTCAE (whatever the cause)
    -Current or recent treatment with another investigational drug or participation in another therapeutic clinical trial (within 30 days of inclusion).
    -History of other cancer in the 5 years preceding inclusion, except for basal cell carcinomas of the skin and in situ carcinomas of the cervix
    -Pregnant or breastfeeding women
    -Contraindication to MRI or gadolinium injection
    -Patient under guardianship or curatorship
    - History of nephropathy
    -Psychological disorder or social or geographic reasons that may compromise medical monitoring of the trial or compliance with treatment
    -ATCD de radiothérapie cérébrale
    -ATCD de chimiothérapie (y compris les implants contenant de la carmustine (Gliadel®) ou immunothérapie (vaccination incluse)
    -Toute contre-indication au TMZ listée dans les RCP
    -ATCD de résection intestinale majeure pouvant modifier l'absorption des médicaments par voie orale selon le jugement de l'investigateur
    -Maladie inflammatoire de l'intestin diagnostiquée (maladie de Crohn ou colite ulcéreuse)
    -Diarrhée ≥ grade 2 CTCAE (quelle que soit la cause)
    -Traitement actuel ou récent avec un autre médicament expérimental ou participation à un autre essai clinique thérapeutique (dans les 30 jours précédents l’inclusion).
    -Antécédent d’autre cancer dans les 5 ans précédents l’inclusion à l’exception des carcinomes baso-cellulaires de la peau et des carcinomes in situ du col
    -Femmes enceintes ou allaitantes
    -Contre-indication à l’IRM ou à l’injection de gadolinium
    -Patient sous tutelle ou curatelle
    -ATCD de néphropathie
    -Désordre psychologique ou raisons sociales ou géographiques pouvant compromettre le suivi médical de l’essai ou la compliance au traitement.
    E.5 End points
    E.5.1Primary end point(s)
    The recommended dose (phase I) of AGuIX in combination with TMZ and radiotherapy during the radio-chemotherapy period is defined as the highest dose tested in which the % of dose-limiting toxicities (DLT) is less than 33%.
    DLT is defined as any grade 3-4 toxicity according to the NCI CTCAE v5.0 classification, except alopecia, nausea, and vomiting which can be quickly controlled with appropriate measures.

    - 6-month Progression-free survival rate (PFS) (phase II):
    The rate of patients who have not presented a progression at 6 months from the starting treatment, i.e. 6 months after the first administration of AGuIX (at the recommended dose).
    Disease assessment will be based on the RANO criteria (Response Assessment in Neuro-Oncology)
    La dose recommandée (phase I) des nanoparticules AGuIX en association avec le TMZ et la radiothérapie au cours de la période de radio-chimiothérapie correspond à la plus forte dose testée dans laquelle le % de toxicités dose limitantes (TDL) est inférieur à 33%.
    La TDL est définie comme toute toxicité de grade 3-4 selon la classification NCI CTCAE v5.0, sauf l’alopécie, les nausées, et les vomissements qui peuvent être rapidement contrôlés par des mesures appropriées.

    -Taux de survie sans progression (SSP) à 6 mois (phase II) :
    Le taux de patients qui n’ont pas présenté de progression à 6 mois du début du traitement soit à 6 mois de la première administration d’AGuIX (à la dose recommandée).
    L'évaluation de la maladie sera basée sur les critères RANO (Response Assessment in Neuro-Oncology)
    E.5.1.1Timepoint(s) of evaluation of this end point
    phase I : Only toxicities occurring during concomitant radiochemotherapy and the following 4 weeks will be considered for the evaluation of DLT (i.e. 11 weeks).
    phase II : 6-month Progression-free survival rate (PFS)
    phase I : Seules les toxicités survenant au cours de la radio-chimiothérapie concomitante et les 4 semaines suivantes seront considérées pour l’évaluation des TDL (soit 11 semaines).
    phase II : Taux de survie sans progression (SSP) à 6 mois (phase II)
    E.5.2Secondary end point(s)
    - Pharmacokinetic parameters: Cmax, Tmax, AUC et T1/2
    - Distribution of nanoparticles : after the first and last injection of AGuIX (at S0 and S3).
    - Overalll survival since the start of treatment. assessment of median survival. The survival rate will be calculated at 6 and 12 months after the start of treatment.
    - the objective response rate according to RANO criteria.
    - The rate 12-month PFS.
    - the median of PFS.
    - The safety profile of AGuIX nanoparticles in combination with radiotherapy and TMZ will be evaluated according to NCI CTC version 5.0 criteria throughout the study.
    - Neurological status will be assessed clinically and using the Mini-Mental State Examination (MMSE) questionnaire
    - The corticosteroid intake will also be evaluated.
    - The predictive biomarker and tumor microenvironment will be assessed on tumoral bloc (used for glioblastoma diagnosis)
    -Les paramètres de pharmacocinétique : Cmax, Tmax, AUC et T1/2
    -La distribution des nanoparticules et l’épargne des tissus sains seront évaluée grâce à la réalisation d’IRM 1h après la première et la dernière l’injection d’AGuIX (à S0 et S3).
    -La survie globale est définie comme le temps écoulé depuis le début du traitement jusqu’au décès. La médiane de survie sera évaluée. Le taux de survie sera calculé à 6 et 12 mois après le début du traitement.
    -Le taux de réponse objective selon les critères RANO.
    -Le taux de SSP à 12 mois selon les critères RANO.
    -La médiane de SSP sera également évaluée.
    -Le profil de tolérance des nanoparticules AGuIX en combinaison avec une radiothérapie et TMZ sera évalué selon les critères NCI CTC version 5.0 tout au long de l’étude.
    -Le statut neurologique sera évalué cliniquement et grâce au questionnaire Mini-Mental State Examination (MMSE)
    -L’évaluation de la prise des corticoïdes sera également réalisée.
    -Les biomarqueurs prédictifs potentiels et le microenvironnement tumoral sera évalué sur le bloc tumoral utilisé pour le diagnostic du glioblastome.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Pharmacokinetic parameters: D0, D7, D14
    - The distribution of nanoparticles : after the first and last injection of AGuIX (at S0 and S3).
    - The survival rate : at 6 and 12 months .
    - the rate 12-month PFS rate
    - The safety profile : throughout the study.
    - Les paramètres de pharmacocinétique : D0, D7, D14
    - La distribution des nanoparticules : après la première et la dernière l’injection d’AGuIX (à S0 et S3).
    - Le taux de survie à 6 et 12 mois
    - Le taux de SSP à 12 mois
    - Le profil de tolérance : tout au long de l’étude.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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 Yes
    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.8.1.7.1Other trial design description
    dose escalation for phase I and open randomised phase II
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard of care : chemoradiotherapy (radiotherapy + temozolomide)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    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
    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: 46
    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 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 state66
    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 Decision2021-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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