ISRCTN56178790已完成不适用
Sorafenib (NEXAVAR®) monotherapy in patients with inoperable/recurrent germ cell carcinoma refractory to chemotherapy
Prof. Grzegorz Madej Memorial Foundation Win the health (Fundacja Wygrajmy Zdrowie im Prof. Grzegorza Madeja) (Poland)0 个研究点目标入组 20 人开始时间: 2008年1月7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
- 20
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. Male patients greater than 18 years of age
- •2. Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary)
- •3. Patients must have the disease not amendable to cure with either surgery or chemotherapy
- •4. Patients must have failed at least two cisplatin-based combination chemotherapy regimens
- •5. Failure on prior regimens will be defined as either:
- •5.1. A greater than or equal to 25% increase in sum of target lesions, new lesions, or
- •5.2. An increasing Alpha Fetoprotein (AFP) or Human Chorionic Gonadotropin (HCG) above the nadir level
- •6. Patients with at least one measurable lesion by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- •7. Adequate bone marrow, liver and renal function, assessed no longer than 14 days before treatment start, defined by the following laboratory test limits:
- •7.1. White Blood Cells (WBC) greater than 2.0 x 10^9/l and platelets greater than 60 x 10^9/l
- •7.2. Total bilirubin less than 2 x Upper Limit of Normal (ULN)
- •7.3. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) less than 5 x ULN
- •7.4. Serum creatinine less than 2 x ULN
- •8. World Health Organization (WHO) performance status 0, 1, 2
- •9. No concurrent chemotherapy or radiotherapy
- •10. Life expectancy of at least 12 weeks
- •11. Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •12. A signed informed consent must be obtained prior to any study specific procedures
- •13. All patients must agree to use adequate contraception during the whole study period
排除标准
- •1. Patients not fulfilling of inclusion criteria
- •2. Primary radiotherapy in the field of target lesion
- •3. Major surgery (Retroperitoneal Lymph Node Dissection [RPLND]) within 4 weeks before the start of study drug or concurrent serious non-healing wounds, ulcers or bone fractures.
- •4. Known serious and active bacterial, viral or fungal infection (greater than grade II Common Terminology Criteria for Adverse Events [CTC-AE]) including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) carrier state
- •5. Previous or concurrent malignancy except for basal cell carcinoma of the skin
- •6. Uncontrolled hypertension
- •7. Thrombotic or embolic event in last 6 months prior to inclusion
- •8. Impairment of Gastrointestinal (GI) tract, or GI disease that may influence the bioavailability of oral sorafenib
- •9. Substance and alcohol abuse (nicotine use is allowed)
- •10. Known or suspected hypersensitivity to sorafenib
- •11. Participance in any other clinical trial using investigational drug within 4 weeks prior to study entry
- •12. Prior use of investigational or licensed angiogenesis and Raf kinase or Mitogen-activated Extracellular-signal-Regulated Kinase (ERK) (MEK) inhibitors
- •13. Patient unwilling or unable to give informed consent
- •14. Any condition that may in the investigator?s opinion jeopardize the safety of the patient or his compliance in the study
研究者
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