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    Summary
    EudraCT Number:2010-020341-27
    Sponsor's Protocol Code Number:GFM-Aza intensif
    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:2010-05-18
    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 number2010-020341-27
    A.3Full title of the trial
    A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine (Vidaza®) in intermediate-2 and high risk MDS patients
    A.3.2Name or abbreviated title of the trial where available
    GFM-Aza intensif
    A.4.1Sponsor's protocol code numberGFM-Aza intensif
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGroupe Francophone des Myélodysplasies
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Azacitidine (Vidaza®)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberORPHA178885
    D.3 Description of the IMP
    D.3.1Product name Azacitidine (Vidaza®)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Myelodysplastic syndromes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Response rate (including CR and PR) according to IWG 2006 criteria for MDS after 4 and 8 cycles 75mg/m2/d azacitidine administered every 2 weeks.
    E.2.2Secondary objectives of the trial
    - Safety/toxicity profil of azacitidine administered every 14 days (NCI-CTAE)
    - Responses (CR, PR, marrow CR, HI) according to IWG 2006 criteria and their duration
    - Overall survival and progression (IPSS/AML) free survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • MDS defined according to WHO classification (also including RAEB-T according to
    FAB classification)(see appendix 1) with an intermediate-2 or high risk MDS IPSS
    score (see appendix 1).
    • Age ≥ 18 years and <70 years.
    • Must understand and voluntarily sign an informed consent form.
    • Must be able to adhere to the study visit schedule and other protocol requirements.
    • Patients must have ECOG performance status (PS) of 0 – 2, and no major
    comorbidities preventing administration of an intensified regimen of azacitidine.
    • 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. Lactating patients are excluded.
    o Agree to use, and to be able to comply with, effective contraception without
    interruption, 4 weeks before starting study drug throughout the entire duration
    study drug therapy (including doses interruptions) and for 3 months after the
    end of the study drug therapy.
    • Male patients must :
    o Agree the need for the use of a condom if engaged in sexual activity with a
    woman of childbearing potential during the entire period of treatment, even if
    disruption of treatment and during 3 months after end of treatment.
    o Agree to learn about the procedures for preservation of sperm before starting
    treatment.
    • Creatinine <1.5 N or estimated clearance of creatinine below 30ml/min.
    • Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase
    (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase
    (SGPT) > 3.0 x upper limit of normal (ULN).
    • Serum total bilirubin > 1.5 mg/dL. (except for unconjugated hyperbilirubinemia due to
    Gilbert’s disease or secondary to MDS-related dyserythropoiesis).
    • Health insurance.
    E.4Principal exclusion criteria
    Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
    • Pregnant and lactating patients are excluded because the effects of azacitidine on a
    foetus or breast-fed child are unknown
    • Uncontrolled intercurrent illness including, but not limited to uncontrolled infection,
    symptomatic congestive heart failure (NYHA > II), cardiac arrhythmia, or psychiatric
    illness/social situations that would limit compliance with study requirements.
    • Patients receiving any other standard or investigational cytotoxic treatment for their
    hematologic malignancy in the last 8 weeks.
    • Any medical condition which in the opinion of the investigator places the patient at an
    unacceptably high risk for toxicities of an intensified regimen of azacitidine.
    • Less than 6 months since prior allogeneic stem cell transplantation.
    • Less than 3 months since prior autologous stem cell transplantation.
    • Prior history of malignancy other than MDS (except basal cell or squamous cell
    carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free
    of disease for ≥ 3 years.
    • Prior treatment with azacitidine.
    • Known allergy/intolerance to azacitidine or mannitol.
    • ECOG > 2.
    • Life expectancy less than 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of the trial will be to assess the response rate according to IWG 2006 criteria for MDS
    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 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 Yes
    E.7.1.3.1Other trial type description
    The Phase I study will assess the efficacy and Safety/toxicity of vidaza administered every 14 days
    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 concerned7
    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 Information not present in EudraCT
    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
    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
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state81
    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 Decision2010-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
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