EUCTR2019-000941-10-PL进行中（未招募）1 期
A Phase I/II Study of SEL24 in Patients with Acute Myeloid Leukemia
Menarini Ricerche S.p.A0 个研究点目标入组 68 人开始时间: 2020年5月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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:
- •-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).
- •-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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •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
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