ISRCTN46317673已完成不适用
A single center open-label uncontrolled study to investigate tumour response and vascularization changes in neoadjuvant therapy with BAY 43-9006 single agent therapy in patients with operable renal cell cancer
Academic Medical Center (AMC), Department of Urology (The Netherlands)0 个研究点目标入组 30 人开始时间: 2006年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients >18 years
- •2. Eastern Cooperative Oncology Group (ECOG) = 1 (2)
- •3. Candidates for a radical or partial nephrectomy who are fit for surgery
- •4. At least one uni-dimensional measurable lesion, measured by computed tomography (CT) scan
- •5. Adequate bone marrow function
- •6. Adequate liver function
- •7. Adequate renal function
- •8. Adequate coagulation
- •9. Men and women must have adequate barrier birth control before and during and for 1 week after the trial
- •10. Signed informed consent
排除标准
- •1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY43- 9006
- •2. History of cardiac disease, congestive heart failure, cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension
- •3. History of chronic hepatitis B or C and HIV infection
- •4. Patients with seizure disorders (requiring medication)
- •5. Patients with evidence or history of bleeding diathesis
- •6. Other investigational drug therapy within 30 days
- •7. Women of childbearing potential with a positive pregnancy test within 7 days before start treatment
- •8. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •9. Unable to swallow oral medication
- •10. Tumour/disease specific criteria: chronic diarrhoea, bowel obstruction, degree of malnutrition, malabsorption
- •11. Major surgery within 4 weeks before screening
研究者
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