EUCTR2019-004896-38-FR进行中（未招募）1 期
Phase I/II, international, multicentre, open-label, non-randomised, non-comparative study evaluating the safety, tolerability and clinical activity of intravenously administered S64315, a selective Mcl-1 inhibitor, in combination with azacitidine in patients with acute myeloid leukaemia (AML)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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-Patients aged = 18 years
- •2-Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by WHO 2016 classification (Arber, 2016) excluding acute promyelocytic leukaemia (APL, French-American-British M3 classification) with: relapsed or refractory disease and without established alternative therapy, or secondary to MDS and without established alternative therapy or, newly diagnosed AML, not previously treated for AML and who are not candidate for intensive chemotherapy due to age or comorbidities.
- •3-Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •4-Adequate haematological, renal and hepatic functions based on the last assessment performed within 7 days prior to the first IMP administration.
- •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 87
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 93
排除标准
- •1-Previous myeloproliferative syndrome (MPS).
- •2-Patient previously treated with hypomethylating agents (HMAs) such as azacitidine or decitabine, during dose escalation phase I part.
- •3-Patients previously treated with any Mcl-1 inhibitor.
- •4-Patients who have not recovered from toxicity of previous anticancer therapy, including Grade = 2 toxicity (except alopecia of any grade) according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 5.0, prior to the first IMP administration.
- •5-Severe or uncontrolled active acute or chronic infection.
- •6-Uncontrolled hepatitis B or C infection.
- •7-Known carriers of HIV antibodies, history of significant liver disease, active acute or chronic pancreatitis, active central nervous system disease.
- •8-Troponin (I or T) > ULN.
- •9-Clinically significant cardiac dysfunction (including NYHA class =II heart failure, Left Ventricular Ejection Fraction (LVEF) < 50% as assessed by echocardiography (ECHO) or Multi-Gated Acquisition (MUGA) scan).
- •10-QT prolongation defined as QTc interval (corrected with Fridericia’s formula) > 450 ms for males and > 470 ms for females, obtained from triplicate 12-lead ECG.
- •11-Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
- •12-Uncontrolled arterial hypertension (systolic blood pressure (SBP) > 150 mmHg or diastolic blood pressure (DBP) > 95 mmHg).
研究者
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