NL-OMON28891尚未招募不适用
A single center open-label uncontrolled study to investigate the PSA and tumor vascularization response rate of neoadjuvant therapy with BAY 43-9006 single agent therapy in patients with operable prostate cancer.
Academic Medical Center, University of Amsterdam. Department of Urology0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients > 18 years;
- •2. 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 BAY43- 9006;
- •2. History of cardiac disease congestive heart failure, cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension;
- •3. History of chronic hepatits 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.;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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