NCT00960258已完成1 期
Phase I, Uncontrolled, Open-label, Non-randomized Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) 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
- 15
- 主要终点
- Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics
研究概览
简要总结
This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.
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
- •Male or female Japanese patients >/= 18 years
- •Histologically or cytologically confirmed solid tumors
- •ECOG-PS 0 - 1
- •Adequate bone marrow, liver and renal function
排除标准
- •Uncontrolled hypertension
- •Patients with severe renal impairment or on dialysis
- •Patients with seizure disorder requiring anticonvulsant medication
- •Known or suspected allergy to the investigational agent.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Regorafenib (BAY73-4506) (Drug)
结局指标
主要结局
Grade 4 neutropenia for >/= 7 days, febrile neutropenia with Grade 4 neutropenia, Grade 4 thrombocytopenia, Grade 3 or 4 non-hematologic toxicity, hypertension and skin toxicity of Grade 3 or 4 which are not manageable and pharmacokinetics
时间窗: After 5 weeks (after Cycle 1).
次要结局
- Response rate(Every 8 weeks for the first 6 cycles. After Cycle 6, every 12 weeks)
- Biomarker(At screening)
研究者
相似试验
已完成
2 期
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCCCarcinoma, Renal CellNCT00664326Bayer49
已完成
1 期
Continuous Dosing of BAY73-4506 in Patients With Advanced MalignanciesNeoplasmNCT01117623Bayer86
已完成
3 期
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionNCT00810693Bayer445
招募中
1 期
Assessment of Safety ,Tolerance and Pharmacokinetics Clinical Efficacy With BAT4706 in Advanced Solid TumorsAdvanced Solid TumorMelanomaNCT05148325Bio-Thera Solutions64
进行中（未招募）
1 期
A Phase II uncontrolled study of BAY 73-4506 (DAST) in previously untreated patients with metastatic or unresectable renal cell cancer (RCC)Renal Cell CarcinomaMedDRA version: 19.0 Level: LLT Classification code 10038407 Term: Renal cell cancer System Organ Class: 100000004864EUCTR2008-000107-28-DEBayer AG41