临床试验/NCT00110344

NCT00110344终止2 期

A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.

Bayer0 个研究点目标入组 1 人开始时间: 2005年11月最近更新: 2013年10月11日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Bayer
入组人数: 1
主要终点: Best Overall Response Rate (complete and partial response rate)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

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

•Life expectancy of at least 12 weeks
•Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon
•At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen
•Patients who have an ECOG performance status of 0 or 1

排除标准

•History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation
•Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field
•Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry

研究组 & 干预措施

Arm 1

Experimental

干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)

Arm 2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Best Overall Response Rate (complete and partial response rate)

时间窗: During study treatment or within 30 days after termination of active therapy

次要结局

Progression-free survival(Last date of tumor assessment)
Safety(all visits)
Overall response rate(Last day of tumor assessement)
Time to response(throughout study)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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