NCT00035243已完成2 期
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following patients may be eligible for this study:
- •Histologically or cytologically documented evidence of epithelial renal cell carcinoma with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
- •Patients must have had a prior nephrectomy
- •Must have a life expectancy of greater than three (3) months
- •Patients who have had 0-1 prior cytokine treatment regimen (i.e. IL-2, IFN-?) or relapsed less than one year after such treatment may be eligible.
排除标准
- •The following patients are not eligible for this study:
- •Patients who have received more than one (1) prior cytokine regimen (i.e. IL-2, IFN?) or relapsed more than one year after receiving such treatment are not eligible
- •Patients who have had any prior chemotherapy (including a combination therapy)
- •Patients with symptomatic CNS metastases or leptomeningeal involvement
- •Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
- •Patients with severe cardiac insufficiency
- •Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
- •History of another malignancy within 3 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ
- •Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
- •HIV+ patients
- •Pregnant or lactating females.
研究组 & 干预措施
EPO906
Experimental
干预措施: epothilone b (Drug)
结局指标
主要结局
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: every 8 weeks
次要结局
- Objective response rate (ORR)(every 8 weeks)
- Time to disease progression (TTP)(every 8 weeks)
- Overall Survival (OS)(every 8 weeks)
- Safety and tolerability of EPO906(at each visit)
- Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma(prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment)
研究者
研究点 (8)
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