A Phase I, Open-Label, Dose-escalation, Multicentre Study of KW-2478 Administered as a Single Agent Intravenously in a Consecutive Dosing Schedule in Patients With Relapsed/Refractory Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose
研究概览
简要总结
The aim of this study is to determine the safety, tolerability and dose-limiting toxicities of KW-2478 and to determine the Maximum Tolerated Dose and recommended Phase II dose for patients with relapsed/refractory MM, CLL or B-cell NHL.
详细描述
This is a Phase I, open-label, dose-escalation study of KW-2478 in patients with relapsed/refractory multiple myeloma, chronic lymphocytic leukaemia or B-cell Non-Hodgkin's lymphoma who have no established therapeutic alternatives. Up to 42 patients will be enrolled at up to six investigational sites over a period of approximately 12 months until an MTD is reached. An additional 12 patients may be enrolled at the MTD in an expanded cohort of one or more of the eligible conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with a confirmed diagnosis of Multiple Myeloma, Chronic Lymphocytic Leukaemia, or B-cell Non-Hodgkin's Lymphoma, who have had at least two prior standard treatment regimens and are without established therapeutic alternatives.
- •Signed IEC-approved informed consent
- •ECOG performance status of 0, 1 or 2;
- •Life expectancy of at least 3 months;
- •Adequate haematologic status, liver function and renal function
- •Patients of reproductive potential must agree to follow accepted birth control methods during the study
排除标准
- •No anti-cancer treatment for ≥ 3 weeks prior to receiving study drug
- •Any other severe, acute or chronic illness
- •No other prior or concurrent malignancy
- •Immunosuppressant therapy
研究组 & 干预措施
I
Intravenous KW-2478 (ascending dose cohorts)
干预措施: KW-2478 (Drug)
结局指标
主要结局
To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose
时间窗: At every visit and at the end of each 14-day treatment cycle
次要结局
- Pharmacokinetics and Pharmacodynamics(At baseline and steady state during cycle 1)