A Multiple Ascending Dose (MAD) Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- AEs, laboratory parameters.
研究概览
简要总结
This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals.
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
- •adult patients, >=18 years of age;
- •locally advanced or metastatic solid tumors;
- •measurable or evaluable disease.
排除标准
- •prior chemotherapy, radiotherapy or immunotherapy within 3 weeks of start of study;
- •prior history of CNS metastases with disease progression;
- •patients taking strong inhibitors and/or inducers of CYP3A4.
研究组 & 干预措施
1
干预措施: RG547 (Drug)
结局指标
主要结局
AEs, laboratory parameters.
时间窗: Throughout study
次要结局
- Pharmacokinetic and pharmacodynamic profiles of R547(Throughout study)
