ISRCTN69484574已完成2 期
A phase II uncontrolled study of BAY 73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC)
Bayer Healthcare Pharmaceuticals Inc. (USA)0 个研究点目标入组 49 人开始时间: 2008年7月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
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. Greater than or equal to 18 years, either sex
- •2. Unresectable and/or metastatic clear cell renal cell cancer
- •3. Previously untreated disease
- •4. Measurable lesion(s) by computed tomography (CT) scan/magnetic resonance imaging (MRI)
- •5. Intermediate or low Motzer score
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •7. Adequate bone marrow, renal and hepatic function as assessed by specific laboratory tests
- •8. Life expectancy of at least 12 weeks
- •9. Signed informed consent
排除标准
- •1. Previous/concurrent cancer
- •2. Previous systemic treatment of RCC
- •3. Cardiac arrhythmias requiring anti-arrythmics
- •4. History of cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) class 2
- •5. Uncontrolled hypertension despite optimal medical management
- •6. Cardiac ventricular arrhythmias requiring anti-arrhythimics
- •7. Active clinically serious infections
- •8. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •9. Know history of symptomatic metastatic brain or meningeal tumours
- •10. Seizure disorders requiring medication
- •11. History of organ allograft
- •12. History or evidence of bleeding diathesis
- •13. Serious non-healing wound, ulcer or bone fracture
- •14. Patients undergoing renal dialysis
- •15. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •16. Known or suspected allergy to the investigational drug or any agent given in association with the trial
- •17. Any condition which is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
- •18. Pregnant or breast-feeding patients
- •19. Investigational drug therapy outside of the trial within 4 weeks of study entry
- •20. Prior exposure to the drug
- •21. Radiotherapy during study or within 3 weeks of start of study drug
- •22. Major surgery, open biopsy or significant traumatic injury within 4 weeks of start of study
- •23. Autologous bone marrow transplant or stem cell rescue within 4 months of study
- •24. Patients unable to swallow oral medications
- •25. Any malabsorption condition
研究者
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