NCT01003015已完成2 期
An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 36
- 主要终点
- Adverse Event Collection
研究概览
简要总结
The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.
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 patients aged equal or above 18 years.
- •BCLC stage Category A, B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
- •Liver function status Child-Pugh class A.
- •Failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
- •Local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of BAY73-
- •ECOG PS of 0 or
- •Adequate bone marrow, liver and renal function
排除标准
- •Prior systemic treatment with molecular targeted agents for HCC, except sorafenib. Prior chemotherapy treatment is allowed.
- •Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
- •Congestive heart failure NYHA>/= class 2
- •Unstable angina (angina symptoms at rest, new onset angina within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.
- •Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- •Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment.
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY73-4506 (Drug)
结局指标
主要结局
Adverse Event Collection
时间窗: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration
次要结局
- Disease control rate(Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression)
- Overall survival(Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression)
- Time to progression(Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression)
- Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only)(Cycle 1 Day 21 to Day 28)
- Trough concentration of Regorafenib and metabolites (for Europe only)(Cycle 1 Day 15 and Cycle 2 Day 1)
- Objective response rate(Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression)
研究者
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