NCT00562913已完成1 期
Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in 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
- 21
- 主要终点
- To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered
研究概览
简要总结
Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients
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
- •At least 18 years old
- •Advanced histological or cytological documentation of cancer
- •life-expectancy of at least 12 weeks
- •able to swallow pills
- •ECOG status of 0,1 or 2
- •adequate bone marrow
- •liver and renal function
排除标准
- •> NYHA Class 2 CHF
- •Serious myocardial dysfunction,
- •or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)
- •History of organ allograft
- •uncontrolled hypertension
- •renal dialysis
- •Bleeding event/hemorrhage within 4 weeks of study treatment
- •major surgery within 4 weeks of study treatment
- •Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose
研究组 & 干预措施
Arm 1
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
结局指标
主要结局
To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered
时间窗: 6 weeks
次要结局
- To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib(6 weeks)
研究者
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