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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-002822-35
    Sponsor's Protocol Code Number:P140910J
    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:2018-02-22
    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 number2016-002822-35
    A.3Full title of the trial
    Treatment with azacitidine of recurrent gliomas with IDH1/2 mutation: AGIR
    Traitement par azacitidine des Gliomes avec mutation IDH1/2 en rechute : AGIR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Vidaza of a brain tumor
    Traitement par Vidaza des tumeurs cérébrales
    A.3.2Name or abbreviated title of the trial where available
    AGIR
    A.4.1Sponsor's protocol code numberP140910J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailmaud.jacubert@aphp.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 Vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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 nameVidaza
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAzacitidine
    D.3.9.1CAS number 320-67-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Treatment with azacitidine of recurrent gliomas with IDH1/2 mutation after conventional treatments (radiotherapy and alkylant chemotherapy)
    Patients ayant un gliome avec mutation IDH1/2, en rechute après traitement conventionnel (radiothérapie et 1 ligne de chimiothérapie alkylante)
    E.1.1.1Medical condition in easily understood language
    Brain tumor
    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 10018338
    E.1.2Term Glioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study will be to evaluate the efficacy based on Radiologic Assessment in Neuro-Oncology (RANO) criteria, of azacitidine in patients with recurrent IDH1/2 mutated glioma after conventional treatments.

    NA
    E.2.2Secondary objectives of the trial
    - To evaluate the clinical efficacy: objective response rateafter 6 cycles of treatment, overall survival
    - To evaluate the safety and tolerability of azacitidine.
    NA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluer l'effet déméthylant chez les patients candidats à une ré-intervention au cours de la recherche.
    E.3Principal inclusion criteria
    1) Age > or equal 18 years
    2) Glioma grade II or III with IDH1 or IDH2 mutation
    3) Recurring after standard treatment, ie radiotherapy and alkylant chemotherapy, or alkylant chemotherapy alone in case of gliomatosis cerebri
    4) For the patients treated by radiotherapy, recurrence occurring more than three months from the end of the radiotherapy or occurring outside the irradiated volume
    5) Karnofsky performans status >50
    6) Life expectancy > 9 months
    7) Living within the geographic perimeter of the APHP home hospitalization center (departments 75,92,93,94)
    8) Suitable laboratory values obtained ? 7 days before inclusion visit:
    - Absolute neutrophil count (ANC) ?1500 /mm3
    - Leucocytes > or equal 3,0 x 109/L
    - Platelet count > or equal 75 000 / mm3
    - Hemoglobin > 9.0 g/dL
    - SGOT (AST) < or equal 3 x ULN
    - SGPT (ALT) < or equal 3 x ULN
    - Uremia < or equal 1.5 x ULN
    - Creatininemia < or equal 1.5 x ULN
    - Bicarbonates > or equal 22 mmol/l
    9) Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must :
    o Have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study.
    o Agree to use, and to be able to comply with, effective contraception without interruption, throughout the entire duration study drug therapy (including doses interruptions) and for 3 months after the end of the study drug therapy.
    10) Male patients :
    o must agree to use a condom if engaged in sexual activity with a woman of childbearing potential during the entire period of treatment and during 3 months after end of treatment.
    o are informed about the procedures for preservation of sperm before starting treatment.
    11) Written informed consent dated and signed, prior to any study specific procedures (sampling, treatment and analyses).
    12) Affiliation to the french health insurance (recipient or assign)
    1) Age > ou égal à 18 ans
    2) Gliome de grade II ou III avec mutation IDH1 ou IDH2
    3) En rechute après traitement standard (radiothérapie et 1 ligne de chimiothérapie alkylante, ou chimiothérapie alkylante seule dans le cas de gliomatose cérébral)
    4) Pour les patients traités par radiothérapie, rechute survenant plus de trois mois après la fin du traitement par radiothérapie ou apparue en dehors du volume irradié
    5) Index de Karnofsky > 50
    6) Espérance de vie > 9 mois
    7) Résidant dans le périmètre géographique du centre hospitalisation à domicile de l'APHP (départements 75.92.93.94)
    8) Paramètres biologiques adéquats (cf. §6.1) datant de moins d'une semaine avant l'inclusion : hémogramme, fonctions rénales et hépatiques, ionogramme sanguin
    9) Pour les femmes en âge de procréer :
    - Test sanguin ou urinaire de grossesse négatif dans les 2 semaines précédant la 1e prise de traitement
    - Utilisation d'un moyen de contraception efficace pendant toute la durée du traitement et 3 mois après la dernière prise et
    10) Pour les hommes, en couple avec une femme en âge de procréer :
    - Utilisation de préservatifs pendant toute la durée du traitement et 3 mois après la dernière prise
    - Informations reçues sur les mesures de préservation de fertilité avant le début du traitement
    11) Signature du consentement éclairé
    12) Affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit)
    E.4Principal exclusion criteria
    1) Breast-feeding women and pregnancy
    2) Any evidence of severe or uncontrolled systemic diseases (as judged by the investigator), including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) (Screening for chronic conditions is not required).
    3) Active pulmonary disease or congestive cardiac insufficiency
    4) Malignant hepatic tumor at a later stage
    5) Intracranial hypertension or important deviation of the midline on the MRI
    6) Any investigational agents or study drugs from a previous clinical study (within 30 days before the first dose of study treatment
    7) Any chemotherapy, anticancer immunotherapy or anticancer agents within 4 weeks (6 weeks for nitrosourea) before the first dose of study treatment,
    8) Any unresolved toxicities (excepted alopecia), from prior therapy greater than CTCAE grade 1 at the time of inclusion.
    9) Known hypersensitivity to Azacitidine or Mannitol (E421), (refer to the Investigator's Brochure).
    1) Femme enceinte et allaitante
    2) Maladie systémique sévère ou non controlée, incluant une hypertension artérielle incontrôlée, un syndrome hémorragique actif, ou une infection active dont hépatite B, hépatite C et virus de l'immunodéficience humaine (VIH). (Le dépistage des maladies chroniques n'est pas requis.)
    3) Maladie pulmonaire active ou insuffisance cardiaque congestive
    4) Tumeur hépatique maligne à un stade avancé
    5) Hypertension intracranienne ou déviation importante de la ligne médiane sur l'IRM
    6) Administration d'un médicament ou produit expérimental en rapport avec une précédente étude clinique dans les 30 jours précédant la première dose du traitement de l'essai
    7) Administration d'une chimiothérapie, immunothérapie anticancéreuse ou médicament anticancéreux dans les 4 semaines (6 semaines pour les nitrosourées) précédant la première dose du traitement de l'essai
    8) Toxicité non résolue (à l'exception de l'alopécie) d'une précédente thérapie, de grade CTCAE > 1 lors de l'inclusion
    9) Hypersensibilité connue à l'azacitidine ou au Mannitol (E421) (refer to the Investigator's Brochure).
    E.5 End points
    E.5.1Primary end point(s)
    The primary assessment criterion will be Progression-Free Survival at 6 months (PFS-6) (24 weeks) estimated by the RANO criteria. PFS is defined as the time from first administration of study treatment to time of tumor progression or death due to any cause, whichever comes first. PFS-6 is the percentage of patients who have not progress 6 months after first administration of study treatment.
    NA
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 cycles of treatment
    6 cycles de traitement
    E.5.2Secondary end point(s)
    - The adverse events will be described and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE V4.0) at each clinical visit, i.e every month until 1 month after the end of treatment.
    - Objective response rate at 6 months is defined by the percentage of patients with complete response and partial response using RANO criteria.
    - Overall survival is defined as the time from study registration to death due to any cause.
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months, 1 year and until progression of the disease
    6 mois, 1 an et 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 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.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    Dernier suivi du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state63
    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 Decision2018-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
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