NCT00234481终止1 期
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Exelixis
- 试验地点
- 6
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of different doses of XL844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
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
- •Patients with recurrent or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- •Prior treatment with at least 2 systemic chemotherapy regimens for CLL
- •Life expectancy of >3 months
- •Adequate liver and kidney function
- •Absolute neutrophil count ≥500/mm3; platelets ≥50,000/dL; hemoglobin ≥9 g/dL
- •Willing to use accepted method of contraception during the course of the study
- •Negative pregnancy test (females)
- •Written informed consent
排除标准
- •Chemotherapy or radiotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
- •Investigational drug within 30 days of the start of treatment
- •Uncontrolled intercurrent illness such as infection or cardiovascular disease
- •Pregnant or breastfeeding women
- •Subjects known to be HIV positive
研究者
研究点 (6)
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