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    Summary
    EudraCT Number:2019-000941-10
    Sponsor's Protocol Code Number:CLI24-001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-05
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-000941-10
    A.3Full title of the trial
    A Phase I/II Study of SEL24 in Patients with Acute Myeloid Leukemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase I/II Study of SEL24 in Patients with Acute Myeloid Leukemia
    A.4.1Sponsor's protocol code numberCLI24-001
    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 SponsorMenarini Ricerche S.p.A
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMenarini Ricerche S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenarini Ricerche S.p.A
    B.5.2Functional name of contact pointAngela Capriati
    B.5.3 Address:
    B.5.3.1Street AddressVia Sette Santi, 1
    B.5.3.2Town/ cityFlorence
    B.5.3.3Post code50131
    B.5.3.4CountryItaly
    B.5.4Telephone number+390555680 9990
    B.5.5Fax number+390555680 597
    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 nameSEL24/MEN1703 25mg
    D.3.2Product code SEL24/MEN1703 25mg
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNNot yet available
    D.3.9.1CAS number 1616359-00-2
    D.3.9.2Current sponsor codeSEL24/MEN1703
    D.3.9.3Other descriptive nameMEN1703
    D.3.9.4EV Substance CodeSUB197008
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    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 nameSEL24/MEN1703 100mg
    D.3.2Product code SEL24/MEN1703 100mg
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNNot yet available
    D.3.9.1CAS number 1616359-00-2
    D.3.9.2Current sponsor codeSEL24/MEN1703
    D.3.9.3Other descriptive nameMEN1703
    D.3.9.4EV Substance CodeSUB197008
    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
    Acute Myeloid Leukemia
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To further characterize the safety profile of single agent SEL24/MEN1703
    E.2.2Secondary objectives of the trial
    To assess anti-leukemic activity of single agent SEL24/MEN1703
    To evaluate the PK profile of SEL24/MEN1703 and its metabolites, as appropriate.
    Evaluation of CYP2D6 phenotyping will be carried out. Results will be reported separately. Left over sample aliquots may be analyzed for metabolite identification purposes.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacodynamics
    The PD activity of SEL24/MEN1703 will be assessed by changes between
    pre- and post-treatment levels of relevant biomarkers e.g. pS6 in
    peripheral blood by using flow cytometry.

    Genetic profile of AML cells
    The genetic profile of AML cells of each patient will be performed by
    using Next Generation Sequencing and/or qRT-PCR. The mutational
    status of patients before and after treatment with SEL24/MEN1703 will
    be assessed by the analysis of a panel of relevant AML mutated genes in
    bone marrow.
    E.3Principal inclusion criteria
    1. Patient with diagnosis of AML (i.e. ≥20% blasts in bone marrow or peripheral blood) harboring IDH1 or IDH2 mutation (as per local
    assessment).
    2. Provide written informed consent prior to Screening.
    3. Male or female patients, age ≥18 years old.
    4. Patient has no standard therapeutic options available (including IDH inhibitors where approved) and has:
    a) Relapsed AML unsuitable for intensive chemotherapy;
    b) Primary refractory AML unsuitable for intensive chemotherapy;
    Clarification note: Patients naïve to IDH inhibitor are eligible ONLY if no IDH inhibitors are approved/available in the country/site where they are
    enrolled.
    Clarification note: patients are eligible regardless of their AML genetic and/or molecular aberrations, if any. However, patients with AML harboring druggable mutations for whom an approved targeted therapy is available (eg FLT3-ITD and/or FLT3-TKD) are eligible ONLY if they have already received such approved targeted therapy
    5. ECOG Performance Status 0, 1 or 2.
    6. Adequate organ function at Screening, including:
    a) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5X the upper limit of normal (ULN);
    b) Total bilirubin ≤2X ULN;
    c) Creatinine clearance ≥40 mL/min (Cockcroft-Gault formula)
    d) Left ventricular ejection fracture (LVEF) ≥40% as per local assessment practice.
    7. A female of childbearing potential, defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (i.e. has serum follicle stimulating hormone level ≥30 IU/L in the absence of hormone replacement therapy, or complete absence of menses for at least 12 consecutive months which is not due to medication), must have a negative pregnancy test within 7 days prior to receiving study drug.
    8. Sexually active male or female patients of childbearing potential may be enrolled providing that:
    Female:
    -Agrees to use an effective method of birth control that both results in a Pearl index < 1 and is considered highly effective as defined by the Clinical Trial Facilitation Group (e.g. combined estrogen and progestogen containing hormonal contraception, progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, vasectomized partner, total sexual abstinence or bilateral tubal occlusion)*.
    -Undergoes a pregnancy test at Day 1 of each treatment cycle and after the end of relevant systemic exposure (30 days from the last study drug administration).
    Male:
    -Agrees to use an effective contraceptive method (condom) during treatment and until the end of relevant systemic exposure. Females of childbearing potential that are partners of male study participants have to observe the same birth control indications that apply to female participants.
    * Hormonal contraceptives are allowed as pre-clinical evaluation of SEL24/MEN1703 confirmed a low interaction between SEL24/MEN1703 and the most common active principles used for this purpose.

    E.4Principal exclusion criteria
    1. Received anti-cancer treatments (including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy or investigational drugs) within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
    2. Prior treatment with a PIM inhibitor.
    3. Hyperleukocytosis (leukocytes >30 x109/L) immediately prior to the first dose of study drug and/or clinical concerns of leukostasis.
    Note: Patients may undergo leukapheresis according to routine practice before the first dose of study drug; where hydroxyurea is used prior to receiving study drug, it may be continued up to Cycle 1, Day 21, although Investigators are asked to stop treatment prior to the first dose of study drug or before Day 7, wherever possible.
    4. Clinically significant active central nervous system (CNS) leukemia.
    Note: Previously treated and controlled CNS leukemia and ongoing standard CNS prophylaxis (e.g. with intrathecal cytarabine) is acceptable.
    5. Patients who have undergone major surgery within 1 month prior to first dose of study drug.
    6. Hematopoietic stem cell transplant within 4 months of first dose of study drug.
    7. Requires systemic immune-modulating therapy (regardless of dose) for the prophylaxis or treatment of GVHD.
    8. Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection, with the exception of patients with documented Grade CTCAE ≤2 infections with evidence of improvement or without evidence of worsening infection.
    9. Known positive serology for human immunodeficiency virus (HIV).
    10. Ongoing drug-induced liver injury, known chronic active hepatitis C (HCV) infection, known chronic active hepatitis B (HBV) infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction cause by cholelithiasis, cirrhosis of the liver, or portal hypertension. Participants with history of chronic HBV and HCV infection are eligible if disease is stable and sufficiently controlled as per investigator's judgment.
    11. Ongoing drug-induced pneumonitis.
    12. Ongoing inflammatory bowel disease.
    13. Pregnancy or breastfeeding.
    14. Concurrent participation in another therapeutic clinical study.
    15. Ongoing toxicity from any prior anti-cancer therapy that has not resolved to Grade 1 or less prior to the first dose of study drug.
    16. Received an agent known to be a sensitive CYP2D6 substrate or a CYP2D6 substrate with a narrow therapeutic range, a strong or moderate CYP2D6 inhibitor, or a BCRP inhibitor within 7 days or a period corresponding to 4-5 half-lives of the agent, prior to the first dose of study drug.
    17. Cardiac dysfunction defined as myocardial infarction within 6 months of study entry, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias or poorly controlled angina.
    18. Are receiving any active treatment for thrombosis.
    19. History of serious ventricular arrhythmia (e.g. VT or VF, ≥3 beats in a row), or QT interval corrected for heart rate (QTc) ≥480 ms.
    Note: QTc values up to 500 ms will be acceptable where patient’s medical history e.g. bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled.
    20. Any disease, syndrome or condition which may affect significantly drug intake via oral route.
    21. Any other prior or current medical condition, intercurrent illness, surgical history, physical or 12- lead electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g. alcohol or drug addiction) that, in the investigator’s opinion, could jeopardize patient safety or interfere with the objectives of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The number and frequency of AE, safety laboratory, vital signs and ECG assessments
    E.5.1.1Timepoint(s) of evaluation of this end point
    There will be ongoing assessment of all adverse events (AEs), changes in laboratory values (clinical chemistry, hematology, coagulation, lipid profile, and urinalysis) and electrocardiograms as further measures of safety and tolerability. All safety parameters will continue to be assessed beyond Cycle 1.
    Vital Signs- Screening, Day 1 of Cycle 1-Cycle2-Cycle 3; Final Study Visit
    ECG- Sreeining, Day 1&Day 7 of Cycle 1; Day 1 of Cycle2-Cycle3; Final Study Visit.
    E.5.2Secondary end point(s)
    - Assessment of bone marrow and peripheral blast % and other assessments of clinical benefit including ORR (CR, CRi, CRh and MLFS),
    PR rate, DoR, RFS, EFS and OS, transfusion conversion rate, transfusion maintenance rate, HSCT rate.
    - Assessment of PK variables, including Cmax, AUC and t½
    E.5.2.1Timepoint(s) of evaluation of this end point
    Bone marrow aspirate/biopsy shall be taken at the following time points: at Screening, either as soon as peripheral lab results become consistent with an objective response or at C3 D1 whichever comes first, at a recommended frequency of every 2 cycles thereafter e.g. C5 D1, C7 D1, etc. (-2 d tolerance) or as clinically indicated, at relapse and FSV.
    Assessment of blasts in peripheral blood will be carried out at Screening, C1 D1 pre-dose, C1 onwards at D14 (or last day of dosing in each cycle; -2 d tolerance from C3 onwards), and FSV.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Italy
    Poland
    Spain
    United States
    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
    End of Study is defined 6 months after first treatment administration to the last subject or as soon as all enrolled patients completed the
    treatment/follow up period, whichever occurs first.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 68
    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)
    Where possible, patients will be followed up every 3 months for up to 1 year from their Final Study Visit regardless of initiation of additional
    treatments to check for disease progression and survival status.
    After End of Study, subjects who are benefiting from the study treatment without disease progression can continue to take SEL24/MEN1703 as per Investigator decision.
    SEL24/MEN1703 supply will be under the responsibility of the Sponsor.
    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 Decision2020-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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