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    Summary
    EudraCT Number:2014-000098-38
    Sponsor's Protocol Code Number:GFM-SGI-110
    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:2014-02-28
    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 number2014-000098-38
    A.3Full title of the trial
    A phase II trial of SGI-110 in patients with ipss high and int 2 myelodysplastic syndrome, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to azacitidine or decitabine after at least 6 courses or relapsing after a response
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of SGI-110 in people with Myelodysplastic syndrome high and Int-2, acute myeloid leukemia ≤ 30% marrow blasts and chronic monocytic leukemia (CMML) type 2
    A.4.1Sponsor's protocol code numberGFM-SGI-110
    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 SponsorGroupe Francophone des Myélodysplasies (GFM)
    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 supportAstex Pharmaceuticals Inc
    B.4.2CountryUnited States
    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 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.3.2Product code SGI-110
    D.3.4Pharmaceutical form Lyophilisate and solvent 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 INNSGI 110
    D.3.9.2Current sponsor codeSGI 110
    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
    Myelodysplastic syndrome high and Int-2, acute myeloid leukemia ≤ 30% marrow blasts and chronic monocytic leukemia (CMML) type 2
    E.1.1.1Medical condition in easily understood language
    Myelodysplastic syndrome
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the response rate (CR+PR+ marrow CR + HI according to IWG 2006 criteria) of the administration of SGI-110 in patients with high-risk MDS, CMML 2, and AML with 20-30% marrow blast without response after at least 6 cycles of azacitidine or decitabine (but without overt progression ie AML progression if patients had no AML at onset of
    azacitidine/decitabine) or doubling of marrow blast percentage between onset of azacitidine/decitabine and screening
    E.2.2Secondary objectives of the trial
    To determine
    •toxicity profile and safety of the SGI-110
    •response duration, time to IPSS progression, and loss of RBC transfusion independence in responders
    •rate of progression to AML
    •overall survival
    To study
    •prognostic factors of response, including IPSS-R, IPSS-karyotype and somatic mutations
    •the correlation between methylation profiles before and during therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Myelodysplastic syndrome including the following categories of the WHO classification: refractory anemia with excess blasts (RAEB), non-proliferative chronic myelomonocytic leukemia (CMML) (leukocytes < 13 G/L but > 10% marrow blasts), AML with 20-30% marrow blasts (RAEB-T according to the FAB classification), at screening time.

    2. Prior treatment with azacitidine or decitabine for at least 6 courses without response
    (CR, PR, marrow CR or stable disease with HI according to IWG 2006 criteria) or relapsing after a response. Non responders will be eligible only in the absence of overt progression, ie AML progression (if patients had no AML at onset of azacitidine/decitabine) or doubling of marrow blast percentage between onset of azacitidine/decitabine and screening

    3. IPSS score >1 (IPSS: Int-2 or High).

    4. Age ≥ 18 years.

    5. Normal liver function, defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal.

    6. Normal renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance ≥ 50 mL/min (according to MDRD formula rather than Cockroft formula in patients older than 65 years) .

    7. Patient is known not to be refractory to platelet transfusions.

    8. Written informed consent.

    9. Patient must understand and voluntarily sign consent form.

    10. Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements.

    11. ECOG performance status between 0-2 at the time of screening.

    12. Women of childbearing potential must: Agree to use effective contraception without interruption throughout the study and for a further 2 months after the end of treatment.

    13. Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and for a further 2 month after the end of treatment if their partner is of childbearing potential.
    E.4Principal exclusion criteria
    1. Severe infection or any other uncontrolled severe condition.

    2. Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months.

    3. Less than 30 days since prior treatment with growth factors (EPO, G-CSF).

    4. Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy.

    5. Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma, or carcinoma in situ of the cervix or breast.

    6. Patient already enrolled in another therapeutic trial of an investigational drug.

    7. HIV infection or active hepatitis B or C.

    8. Women who are or could become pregnant or who are currently breastfeeding.

    9. Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form.

    10. Patient eligible for allotransplantation.

    11. Known allergy to SGI-110 or any of its excipients.

    12. No affiliation to an insurance system.

    E.5 End points
    E.5.1Primary end point(s)
    -Number of complete Remission (CR), CR with incomplete hematological recovery (CRi), Partial Remission (PR), Marrow CR and Hematological Improvement (HI)according to IWG 2006 criteria after 6 treatment cycles
    E.5.1.1Timepoint(s) of evaluation of this end point
    The response rate will be evaluated after six cycles, according to IWG 2006 criteria.
    E.5.2Secondary end point(s)
    - Duration of response, measured from the date an objective response was achieved to the date of relapse or progression or the date of last contact if no event occurred.
    - Overall survival measured from the date of enrollment to death or the date of last contact.
    - Prognostic factors of response including biological correlates (mutational analysis, methylation profiles)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Duration of response
    - Overall survival
    - Prognostic factors of response
    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 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 concerned21
    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
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state54
    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 Decision2014-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-23
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