NCT00562523已完成1 期
A Phase I Dose Escalation Study With Sorafenib Administered Continuously in Combination With Docetaxel Administered Once Every Three Weeks in Patients With Advanced 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
- 17
- 主要终点
- To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib
研究概览
简要总结
The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.
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
- •Age greater than or equal to 18 years
- •Advanced histological or cytological documentation of cancer
- •At least one evaluable lesion
- •ECOG Performance Status of 0 or 1
- •No more than one prior chemotherapy regimen (prior adjuvant therapy, immunotherapy or hormone treatment are allowed and not restricted)
- •Life expectancy of at least 12 weeks
- •No previous exposure to docetaxel or sorafenib
- •Adequate bone marrow, liver and renal function as assessed by the following:
- •Hemoglobin greater than or equal to 9.0 g/dL
- •Absolute neutrophil count (ANC) greater than or equal to 2,500/mm3
- •Platelet count greater than or equal to 100,000/mm3 Hepatic
- •Total Bilirubin less than or equal to ULN
- •AST, ALT and Alkaline Phosphatase less than 1.5x ULN.
- •PT-INR/PTT less than 1.5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or heparin will be allowed to participate provided that the INR less than 1.
- •In addition, these patients must be monitored at appropriate intervals throughout study)
- •Serum creatinine less than or equal to 1.5 x upper limit of normal
排除标准
- •Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
- •Active clinically serious infections (> Grade 2 NCI-CTCAE Version 3.0)
- •Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- •Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •Peripheral neuropathy > Grade 1
- •Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to screening
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
- •Pregnant or breast feeding women
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib
时间窗: 6 weeks
次要结局
- To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together(6 weeks)
研究者
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终止
1 期
Sorafenib in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00436579National Cancer Institute (NCI)110