NCT00104117已完成1 期
A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.
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
- •Advanced solid tumor
- •Cancer that has progressed on currently available therapies
- •Life expectancy of >3 months
- •Adequate bone marrow, liver, and kidney function
- •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 within 4-6 weeks of the start of treatment (depending on the therapy)
- •Radiotherapy within 4 weeks of the start of treatment
- •Subjects with known brain metastasis
- •Uncontrolled medical disorder such as infection or cardiovascular disease
- •Subjects known to be HIV positive
- •Pregnant or breastfeeding women
结局指标
主要结局
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors
时间窗: Inclusion until 30 days post last treatment
次要结局
- To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors(Various timepoints from pre-dosing until 48 hours post dose.)
- To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.(At various timepoints from pre-dosing until 48 hours post dosing)
研究者
研究点 (4)
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