NCT00044564已完成2 期
An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
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
- 54
- 主要终点
- Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses
研究概览
简要总结
In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.
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
- •measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function
排除标准
- •excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Bay 59-8862 (Drug)
结局指标
主要结局
Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses
时间窗: At baseline and every 2 cycles during the treatment period
次要结局
- Duration of response(At baseline and every cycle during the treatment period)
- Overall survival(Till end of follow up period (up to 2 years))
- Time to progression(Throughout study)
- Pharmacokinetics assessment(At cycle 1)
- Qualitative and quantitative toxicity profile(Day 1 of each cycle or as clinically indicated)
- Physical examinations(As clinically indicated)
- Vital signs data(Throughout study period)
- Abnormal laboratory tests(Prior to every cycle till last study visit)
研究者
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