ISRCTN62522358已完成不适用
A single center open-label uncontrolled study to investigate the prostate specific antigen (PSA) and tumor vascularization response rate of neoadjuvant therapy with BAY 43-9006 single agent therapy in patients with operable prostate cancer
Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 30 人开始时间: 2006年3月8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
- Male
入选标准
- •1. Patients >18 years
- •2. Eastern Cooperative Oncology Group (ECOG) = 1(2)
- •3. Biopsy proven prostate cancer
- •4. Candidate for a radical prostatectomy and fit for surgery
- •5. Clinical stage T1-T2 Nx-0 Mx-0
- •6. Adequate bone marrow function
- •7. Adequate liver function
- •8. Adequate renal function
- •9. Adequate coagulation
- •10. Men and partners must have adequate barrier birth control before and during and for 1 week after the trial
- •11. Signed informed consent
排除标准
- •1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006
- •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 human immunodeficiency virus (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. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •8. Unable to swallow oral medication
- •9. Tumour/disease specific criteria: chronic diarrhoea, bowel obstruction, degree of malnutrition, malabsorption
- •10. Major surgery within 4 weeks before screening
研究者
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