An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 19
- 主要终点
- To study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer.
研究概览
简要总结
This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or cytologically confirmed advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).
- •Renal function must fall into one of the following categories:
- •Normal function - creatinine clearance greater than or equal to 80 mL/min.
- •Moderate impairment - creatinine clearance >30 to 50 mL/min.
- •Severe impairment - creatinine clearance 15 to less than 30 mL/min.
- •Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times the ULN (in the case of liver metastasis less than or equal to 5 times ULN). In the case ALP >3 times the ULN (in the absence of liver metastasis) or >5 times the ULN (in the presence of liver metastasis), and the subject is also known to have bone metastasis, the liver specific ALP must be separated from the total and used to assess the liver function instead of the total ALP.
排除标准
- •Subjects with mild renal impairment (creatinine clearance greater than 50 to less than 80 mL/min).
- •Subjects with end stage renal disease (creatinine clearance less than 15 mL/min or on dialysis).
- •Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivatives.
- •Subjects with prior participation in an HALAVEN clinical study, even if not previously assigned to HALAVEN treatment.
- •Radiation therapy encompassing >30 % of bone marrow.
- •Subjects with organ allografts requiring immunosuppression.
研究组 & 干预措施
Cohort 3
干预措施: E7389 (Drug)
Cohort 1
干预措施: E7389 (Drug)
Cohort 2
干预措施: E7389 (Drug)
结局指标
主要结局
To study the influence of moderate and severe renal impairment on the Composite of Pharmacokinetics of HALAVEN following a single intravenous administration to subjects with cancer.
时间窗: Halaven will be measured on Day 1 and 8 of a 21 day cycle.
The primary analysis will be conducted using the dose-normalized primary PK parameters (AUC0-inf, AUC0-last, and Cmax) respectively. Relationships between each individual PK parameter and renal function (creatinine clearance) will be analyzed by linear regression models using the PK parameter as the dependent variable and renal function as the independent variable.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of HALAVEN in subjects with moderate or severe renal impairment, as well as in those with normal renal function.(Halaven will be measured on Day 1 and 8 of a 21 day cycle.)