NCT01096030已完成1 期
Uncontrolled, Open-label, Non-randomized, Phase 1 Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of BAY73-4506 in Chinese Patients With Advanced, Refractory Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 33
- 主要终点
- Pharmacokinetics as measured by cmax and AUC
研究概览
简要总结
This will be an uncontrolled, open-label, non-randomized, phase I study. The primary objectives of this study are to define the pharmacokinetics (PK) and to evaluate the safety and tolerability of Regorafenib administered orally as a single agent in Chinese patients with advanced solid tumors. The secondary objectives are to evaluate tumor response of patients treated with Regorafenib.
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
- •Male or female Chinese subjects >/- 18 years
- •Advanced, histologically or cytologically confirmed solid tumors
- •Subjects malignancies must be refractory to standard treatment or have no standard therapy available, or the subject actively refused any treatment that would be regarded standard, and/or if, in the judgment of the investigator or his/her designated associate(s), experimental treatment is clinically and ethically acceptable.
- •Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1;
- •Adequate bone marrow, liver and renal function
- •Life expectancy of at least 3 months
排除标准
- •Unstable/uncontrolled cardiac disease
- •History of arterial or venous thrombotic or embolic events
- •Malabsorption condition
- •Severe renal impairment; persistent proteinuria >/= Grade 3
- •Symptomatic metastatic brain or meningeal tumors
- •Clinically significant bleeding >/=Grade 3 within 30 days before start of study medication.
研究组 & 干预措施
Regorafenib
Experimental
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Pharmacokinetics as measured by cmax and AUC
时间窗: Cycle 0, Day 1-5,Cycle 1 Day 1,8,15,21,Cycle 2 Day 1,Modified Dosing Cycle Day 21
Adverse Event collection
时间窗: every 1-2 weeks
次要结局
- Objective tumor response rate(Every 8 weeks for the first 6 cycles, afterwards every 12 weeks)
研究者
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