NCT00134186已完成2 期
Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
研究概览
简要总结
The purpose of this study is to find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥ 18 years old
- •Histologically confirmed renal cell carcinoma with clinically or pathologically confirmed progression
- •Ineligible for interleukin-2 (IL-2) treatment and/or have had 2 or fewer prior treatments
- •Measurable disease
- •Hemoglobin ≥ 9 mg/dL
- •ECOG performance status of 0, 1, or 2
- •Willing and able to provide written informed consent
排除标准
- •Inadequate bone marrow, renal and liver function by laboratory criteria
- •Absolute neutrophil count < 1500/µL;
- •Platelet count < 100,000/µL;
- •AST or ALT > 2 x upper limit of normal (ULN);
- •Alkaline phosphatase > 5 x ULN;
- •Total bilirubin > 2 x ULN;
- •Creatinine > 2.0 mg/dL.
- •Evidence of central nervous system metastases within past year
- •Uncontrolled hypertension
- •Known history of porphyria, G6PD deficiency or HIV
结局指标
主要结局
Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
次要结局
- Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD])
- Time to progression
- Progression-free survival
- Overall survival and survival at 6 and 12 months
- Duration of clinical response
研究者
研究点 (2)
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