An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax, a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia (AML).

Institut de Recherches Internationales Servier9 个研究点分布在 3 个国家目标入组 37 人开始时间: 2018年11月28日最近更新: 2024年2月5日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Institut de Recherches Internationales Servier
入组人数: 37
试验地点: 9
主要终点: Incidence and severity of AEs

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the safety profile, tolerability and the Recommended Phase 2 Dose of the combination S64315 with venetoclax in patients with Acute Myeloid Leukaemia.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female aged ≥ 18 years;
•Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization (WHO) 2016 classification (Arber, 2016), excluding acute promyelocytic leukaemia (APL, French-American British M3 classification):
•With relapsed or refractory disease without established alternative therapy or
•Secondary to MDS treated at least by hypomethylating agent and without established alternative therapy or
•≥ 65 years not previously treated for AML and who are not candidates for intensive chemotherapy nor candidates for established alternative therapy
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
•Able to comply with study procedures
•Adequate renal function within 7 days before the inclusion of the patient defined as:
•Serum creatinine ≤ 1.5 x ULN (upper normal limit) or calculated creatinine clearance (determined by MDRD) > 50 mL/min/1.73m2
•Adequate hepatic function within 7 days before the inclusion of the patient defined as:
•AST and ALT ≤ 1.5 x ULN
•Total serum bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome, who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN

排除标准

•Participant already enrolled and treated in the study
•Pregnancy, breastfeeding or possibility of becoming pregnant during the study
•Participation in another interventional study requiring investigational treatment intake at the same time or within 2 weeks or at least 5 halflives (whichever is longer) prior to first dose of IMP (participation in non-interventional registries or epidemiological studies is allowed). In case of biologic agents with a long half life such as CART cells, immune checkpoint antibodies, bispecific antibodies a flat wash-out of 28 days will be acceptable
•Presence of ≥ CTCAE Grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE, version 4.03).
•Known carriers of HIV antibodies
•Known history of significant liver disease
•Uncontrolled hepatitis B or C infection
•Known active acute or chronic pancreatitis
•History of myocardial infarction (MI), unstable angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
•Any factors that could increase the risk of QTc prolongation or risk of arrhythmic events.