NCT00754104撤回1 期
A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Abbott
- 主要终点
- Pharmacokinetics
研究概览
简要总结
Study of ABT-869 in Combination with Tarceva in Subjects with 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 must have a histologically or cytologically confirmed non-hematologic malignancy.
- •Subject must have an ECOG Score of 0-
- •Adequate organ function.
排除标准
- •Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed.
- •Subject has untreated brain or meningeal metastases.
- •History of greater than 10% weight loss.
- •Has clinically relevant hemoptysis.
- •Subject has proteinuria CTC grade >
- •Must not have had radiation therapy or major surgery within 21 days of study day
- •The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) > 100 mmHg or systolic blood pressure (SBP) > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
- •The subject has a documented left ventricular ejection fraction (LVEF) < 50%.
研究组 & 干预措施
A
Experimental
干预措施: ABT-869 (Drug)
A
Experimental
干预措施: Tarceva (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: Day 7, 15, 21, 35 and Day 1 of every 8 weeks
次要结局
未报告次要终点
研究者
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