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    Summary
    EudraCT Number:2020-003671-17
    Sponsor's Protocol Code Number:NANOPRO
    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:2021-01-05
    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 number2020-003671-17
    A.3Full title of the trial
    Nanoparticle reirradiation and hypofractionated protontherapy of pan-tumor relapse: non-randomized phase II study.
    Réirradiation par nanoparticules et protonthérapie hypofractionnée des rechutes pan-tumeurs : étude de phase II non randomisée.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nanoparticle reirradiation and hypofractionated protontherapy of pan-tumor relapse: non-randomized phase II study.
    Réirradiation par nanoparticules et protonthérapie hypofractionnée des rechutes pan-tumeurs : étude de phase II non randomisée.
    A.3.2Name or abbreviated title of the trial where available
    NANOPRO
    NANOPRO
    A.4.1Sponsor's protocol code numberNANOPRO
    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 François Baclesse
    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 supportGIRCI Nord-Ouest
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre François Baclesse
    B.5.2Functional name of contact pointLECONTE Alexandra
    B.5.3 Address:
    B.5.3.1Street Address3 Avenue du Général Harris
    B.5.3.2Town/ cityCAEN
    B.5.3.3Post code14076
    B.5.3.4CountryFrance
    B.5.4Telephone number33231455050
    B.5.5Fax number33231455158
    B.5.6E-maila.leconte@baclesse.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 Powder and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAGuIX
    D.3.9.2Current sponsor codeAGuIX
    D.3.9.3Other descriptive namePOLYSILOXANE GD-CHELATES BASED NANOPARTICLES
    D.3.9.4EV Substance CodeSUB182631
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.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
    recurrent tumors
    Tumeurs récidivantes
    E.1.1.1Medical condition in easily understood language
    Patients with a relapse of a radioresistant tumor in localization already irradiated.
    patients présentant une rechute de tumeur radiorésistante en territoire déjà irradié.
    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 10038111
    E.1.2Term Recurrent 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
    To assess the local efficacy of a treatment combining the administration of nanoparticles with proton therapy delivered according to a hypofractionated regimen in patients with a relapse of a radiation-resistant tumor in already irradiated territory.
    Evaluer l'efficacité locale d’un traitement associant l’administration de nanoparticules à la protonthérapie délivrée selon un schéma hypofractionné chez des patients présentant une rechute de tumeur radiorésistante en territoire déjà irradié.
    E.2.2Secondary objectives of the trial
    - The tolerance profile
    - Progression-free survival in the reirradiation field and outside the reirradiation field
    - The quality of life of patients
    - Survival without degradation of the quality of life
    - Overall survival
    - The complete or partial response rate at one year (according to the TCP definition)
    - Le profil de tolérance
    - La survie sans progression dans le champ de réirradiation et en dehors du champ de réirradiation
    - La qualité de vie des patients
    - La survie sans dégradation de la qualité de vie
    - La survie globale
    - Le taux de réponse complète ou partielle à un an (selon la définition TCP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient with tumor of the cephalo-spino-iliosacral axis corresponding to the spectrum of tumors treated in proton therapy, in particular base of the skull, pharyngeal wall, parapharyngeal and retropharyngeal lymph nodes, cavum without associated lymph node, pre-spinal tumor, etc. (sites where the tumors are immobile unlike visceral thoracic, abdominal and pelvic tumors which may be mobile which will be excluded because they cannot be irradiated in proton therapy)
    - Tumor already irradiated, within more than 6 months before inclusion
    - Patient with a relapse or a new tumor in irradiated territory
    - Tumor considered to be radioresistant (TCD50> 50Gy)
    - Dosimetry (s) of previous irradiations available
    - Tumor evolving into tissue already irradiated to at least 40 Gy EQD2 (α / β = 2)
    - indication of curativef re-irradiation by proton-therapy
    -Patient avec tumeur de l’axe céphalo-spino-ilio-sacré correspondant au spectre des tumeurs traitées en protonthérapie notamment base du crâne, paroi pharyngée, ganglions parapharyngés et rétropharyngés, cavum sans ganglion associé, tumeur pré-rachidienne… (sites où les tumeurs sont immobiles par opposition aux tumeurs viscérales thoraciques, abdominales et pelviennes possiblement mobiles qui seront exclues car non irradiables en protonthérapie en l’état actuel de la technique),
    - Tumeur déjà irradiée, dans un délai de plus de 6 mois avant l’inclusion
    - Patient présentant une rechute ou une nouvelle tumeur en territoire irradié
    - Tumeur considérée comme radiorésistante (TCD50 > 50Gy)
    - Dosimétrie(s) des irradiations précédentes disponible(s)
    - Tumeur évoluant en tissu déjà irradié à au moins 40 Gy EQD2 (α/β=2)
    -Indication d’une réirradiation par protonthérapie à intention curative. L’indication de réirradiation par protonthérapie sera discutée selon la taille et la localisation tumorale (notamment un volume inférieure ou égale à 113 ml de PTV en situation ORL pourra être pris en compte), la présence de toxicités précédentes. Elle sera validée après passage en RCP au Centre François Baclesse
    E.4Principal exclusion criteria
    - Mobile tumors
    - Lymphomas, brain tumors (gliomas), meningiomas, skin carcinomas, Malignant melanomas (skin or mucous membranes),laryngeal tumor, mobile lesions of the oral cavity
    - Recurrence occurring less than 6 months from the end of the prior irradiation
    - Patient with a contraindication to radiotherapy
    - Patient with progressive visceral or cerebral metastases
    - Tumeurs mobiles
    - Lymphomes, tumeurs cérébrales (gliomes), méningiomes, carcinomes de la peau, mélanomes malins (peau ou muqueuses),tumeur du larynx, lésions mobiles de la cavité buccale
    - Récidive survenant à moins de 6 mois de la fin de l'irradiation préalable
    - Patient présentant une contre-indication à la radiothérapie
    - Patient ayant des métastases viscérales ou cérébrales évolutives
    E.5 End points
    E.5.1Primary end point(s)
    The local progression-free survival rate at 2 years, defined by the proportion of patients alive and without local progression two years after the start of proton therapy according to RECIST 1.1 criteria
    Le taux de survie sans progression locale à deux ans, défini par la proportion de patients en vie et sans progression locale deux ans après le début de la proton-thérapie selon les critères RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 ans
    E.5.2Secondary end point(s)
    - Acute and late toxicities assessed according to NCI CTCAE v. 5.0 in terms of types of toxicities, grade, time to onset and reversibility.
    - Progression-free survival at 2 years, defined by the time between the start of treatment and the date of tumor progression (according to RECIST 1.1 criteria) or death from whatever cause
    - Quality of life score, according to the standardized QLQ-C30 quality of life questionnaire
    - Survival without degradation of the quality of life defined by the time between the start of treatment and death whatever the cause or a deterioration in the quality of life defined by a reduction of more than 10 points in the quality score of overall life of the QLQ-C30 questionnaire
    - Overall survival defined by the time between the start of treatment and the date of death regardless of the cause
    - Proportion of patients with a complete or partial response one year after the end of proton therapy, according to the TCP definition
     Toxicités aiguës et tardives évaluées selon les critères NCI CTCAE v. 5.0 en termes de types de toxicités, de grade, de délai de survenue et de réversibilité.
     Survie sans progression à deux ans, définie par le délai entre le début du traitement et la date de progression tumorale (selon les critères RECIST 1.1) ou de décès quelle qu’en soit la cause
     Score de qualité de vie, selon le questionnaire standardisé de qualité de vie QLQ-C30
     Survie sans dégradation de la qualité de vie définie par le délai entre le début du traitement et le décès quelle qu’en soit la cause ou une dégradation de la qualité de vie définie par une diminution de plus de 10 points du score de qualité de vie globale du questionnaire QLQ-C30
     Survie globale définie par le délai entre le début du traitement et la date du décès quelle qu’en soit la cause
     Proportion de patients présentant une réponse complète ou partielle un an après la fin de la protonthérapie, selon la définition TCP
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to progressive disease
    jusqu'à progression de la maladie
    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 Information not present in EudraCT
    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 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 Information not present in EudraCT
    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
    2 years after last inclusion
    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 months60
    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: 51
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 state51
    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 Decision2021-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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