NCT00350831已完成1 期
A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of the KIT Inhibitor XL820 Administered Orally Daily 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
- 发起方
- Exelixis
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- maximum tolerated dose
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to 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
- •Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival
- •Subject is at least 18 years old
- •Subject has ECOG performance status ≤ 2
- •Subject has a life expectancy of > 3 months
- •Subject has adequate organ and marrow function
- •In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH
- •Subject has given written informed consent
- •Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study.
- •Female subjects of childbearing potential must have a negative pregnancy test at screening.
排除标准
- •Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier
- •Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment
- •Subject has received an investigational agent within 30 days of the first dose of XL820
- •Subject has known brain metastases
- •Subject has known uncontrolled intercurrent illness
- •Subject is pregnant or lactating
- •Subject is known to be positive for HIV
- •Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation
结局指标
主要结局
maximum tolerated dose
safety and tolerability
次要结局
- plasma pharmacokinetics
- pharmacodynamic effects
- long-term safety and tolerability
研究者
研究点 (4)
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