NCT00061178撤回3 期
Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy & Safety of rhuMAb VEGF in Previously Treated Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
研究概览
简要总结
The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and effective for the treatment of renal cell cancer when other treatments have failed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Histologically confirmed, metastatic renal cell cancer (RCC) of clear cell histology
- •Clinical or radiographic evidence of disease progression (as assessed by the investigator and reviewed by the Sponsor) during or after completion of one, and only one, cytokine-based regimen for metastatic disease
- •At least 21 days since any prior therapy for RCC
- •Prior nephrectomy
- •Use of an acceptable means of contraception (potentially fertile men and women)
- •ECOG performance status of 0 or 1
- •Life expectancy >= 3 months
- •Age 18 years or older
排除标准
- •RCC of papillary or collecting-duct type
- •More than one nonsurgical therapy for metastatic RCC (note that medroxyprogesterone acetate not used for physiologic replacement or birth control is considered a therapy for RCC for the purposes of this study)
- •Prior treatment with thalidomide
- •Radiotherapy within 14 days of Day 0
- •Current, recent (within 21 days of Day 0), or planned participation in an experimental drug study
- •Pregnant or breast-feeding subjects
- •Any of the following screening clinical laboratory values: 24-hour urine collection with >= 1 g of protein; Serum creatinine > 2.0 mg/dL; Absolute neutrophil count (ANC) <500/mL; Platelet count <75,000/mL; INR >= 1.5; Total bilirubin > 2.0 mg/dL; AST or ALT > 5 x the upper limit of normal (ULN) for subjects with documented liver metastases or > 2.5 x the ULN for subjects without evidence of liver metastases; Hemoglobin < 9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level)
- •Other invasive malignancies within 5 years of randomization (other than squamous or basal cell carcinoma of the skin)
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
- •Inability to comply with study and/or follow-up procedures
研究者
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