NCT00118456已完成1 期
A Phase I/II, Multicenter, Randomized Dose-Escalation Study of Oral AEE788 on Intermittent Dosing Schedules in Adult Patients With Advanced Cancer (Effective Amendment 5) Previously Entitled A Phase IA, Multicenter, Dose-Escalating Study of Oral AEE788 on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 5
- 主要终点
- Maximum-tolerated dose and dose-limiting toxicity of AEE788
研究概览
简要总结
AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically confirmed solid tumor
- •Adequate hematologic, renal and hepatic function
- •Age ≥ 18 years
- •Karnofsky performance status score ≥ 70%
- •Life expectancy ≥ 12 weeks
排除标准
- •Active brain metastases
- •Peripheral neuropathy > grade 2
- •Diarrhea > grade 1
- •Gastrointestinal (GI) dysfunction
- •Compromised cardiac function
- •Concurrent severe and/or uncontrolled medical conditions
研究组 & 干预措施
1
Experimental
Continuous daily dosing
干预措施: AEE788 (Drug)
2
Experimental
Monday, Wednesday, Friday Dosing
干预措施: AEE788 (Drug)
结局指标
主要结局
Maximum-tolerated dose and dose-limiting toxicity of AEE788
时间窗: 4.5 years
Maximum-tolerated dose, safety and tolerability of AEE788
时间窗: 4.5 years
次要结局
- Single dose and repeated dose pharmacokinetic profile of AEE788(4.5 years)
- Changes in glucose metabolism/cell viability(4.5 years)
- Pharmacodynamic effects(4.5 years)
研究者
研究点 (5)
Loading locations...
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