EUCTR2019-000941-10-IT进行中（未招募）1 期
A Phase I/II Study of SEL24 in Patients with Acute Myeloid Leukemia -
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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.
- •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 and has:
- •a) Relapsed AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy;
- •b) Primary refractory AML not eligible for any approved chemo- or 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) (see
- •Appendix B);
- •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 must agree to use two medically accepted forms of effective contraception e.g. oral, parenteral or implanted contraceptives, intrauterine devices and barrier methods with spermicides, for the entire duration of the study and for 30 days after the final administration of study drug.
- •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 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
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 for targeted therapies (whichever is shorter) before 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 infections who are receiving therapy 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.
- •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 lead II 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 inter
研究者
相似试验
进行中（未招募）
1 期
A Phase I/II Study of SEL24 in Patients with Acute Myeloid LeukemiaAcute Myeloid LeukemiaEUCTR2019-000941-10-PLMenarini Ricerche S.p.A68
已完成
2 期
A Phase 2 study of SAR245409 in patients with relapsed or refractory mantle cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphomachronic lymphocytic leukemia (CLL)non Hodgkin lymphoma (NHL)1002432410025320NL-OMON36096Sanofi-aventis10
进行中（未招募）
不适用
A study of investigational SAR245409 in patients with certain lymphoma or leukemiaymphomaMedDRA version: 13.1Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001616-57-BEsanofi-aventis recherche & développement138
进行中（未招募）
不适用
A study of investigational SAR245409 in patients with certain lymphoma or leukemiaEUCTR2011-001616-57-DEsanofi-aventis recherche & développement180
未知
1 期
A Phase 1 Study of LY2523355 in Patients with Solid CancerJPRN-jRCT2080221457Kyowa Hakko Kirin Co., Ltd.