NCT00113113已完成1 期
Phase I Study of Rubitecan (RFS 2000) in the Treatment of Cancer Patients With Organ Dysfunction
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
研究概览
简要总结
Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •The patient is at least 18 years of age.
- •The patient has histologically or cytologically proven malignancy recurrent or refractory to standard treatment or for which there is no standard therapy.
- •The patient has measurable disease.
- •The patient has sufficiently recovered from the acute toxic effects of previous chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or immunotherapy.
- •The patient's estimated life expectancy is at least 8 weeks.
- •The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC) Performance Status between 0 and
- •The patient has adequate bone marrow function.
- •The patient must not have active central nervous system (CNS) metastases.
排除标准
- •The patient has any serious, uncontrolled intercurrent illness or infection.
- •The patient is receiving anti-retroviral therapy (HAART) for HIV infection.
- •The patient is pregnant or nursing.
研究者
研究点 (4)
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