NCT00336765已完成1 期
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 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
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Evaluate safety, tolerability, and maximum tolerated dose of XL647
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 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 histologically confirmed malignancy that is metastatic or unresectable
- •Subject has disease that is assessable by tumor marker, physical, or radiologic means
- •Subject is at least 18 years old
- •Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
- •Subject has a life expectancy ≥ 3 months
- •Subject has normal organ and marrow function
- •Subject gives written informed consent
- •Subject must use an accepted method of contraception during the study
- •Female subjects of childbearing potential must have a negative pregnancy test
排除标准
- •Subject has received anticancer treatment within 30 days of first dose of XL647
- •Subject has received another investigational agent within 30 days of first dose of XL647
- •Subject has known brain metastases
- •Subject has corrected QT interval (QTc) of > 0.45 seconds
- •Subject is currently receiving anticoagulation therapy with warfarin
- •Subject has uncontrolled intercurrent illness
- •Subject is pregnant or breastfeeding
- •Subject has known HIV
结局指标
主要结局
Evaluate safety, tolerability, and maximum tolerated dose of XL647
时间窗: Inclusion until 30 days post last treatment
次要结局
- Characterize pharmacokinetics and pharmacodynamic effects of XL647(At various time points from pre-dosing until post dosing)
- Evaluate preliminary tumor response(Inclusion until disease progression)
研究者
研究点 (4)
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