NCT00606866已完成3 期
Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib
研究概览
简要总结
The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Histologically or cytologically confirmed metastatic clear cell renal cell cancer;
- •At least one lesion that can be accurately measured in at least one dimension;
- •Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;
- •Age 18 and older;
- •ECOG performance status 0-2;
- •Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
- •Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl;
- •Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Chemotherapy or radiotherapy within 4 weeks prior to entering the study;
- •Any other investigational agents;
- •Known brain metastases;
- •Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
- •Pregnancy.
研究组 & 干预措施
I
Placebo Comparator
placebo pill
干预措施: placebo (Drug)
II
Active Comparator
Sorafenib, 200 mg bid
干预措施: Sorafenib (Drug)
III
Active Comparator
Sorafenib, 400 mg bid
干预措施: Sorafenib (Drug)
结局指标
主要结局
To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib
时间窗: 8 weeks
次要结局
- To predict which patients are most likely to experience tumor shrinkage.(8 weeks)
研究者
研究点 (1)
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