NCT00891605已完成1 期
A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Paclitaxel in the Treatment of Subjects With Solid Tumors
AbbVie0 个研究点目标入组 19 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 主要终点
- Safety Assessment
研究概览
简要总结
Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.
详细描述
A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination with Paclitaxel in the Treatment of 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paclitaxel and ABT-263
Experimental
干预措施: ABT-263 (Drug)
Paclitaxel and ABT-263
Experimental
干预措施: paclitaxel (Drug)
结局指标
主要结局
Safety Assessment
时间窗: Weekly
Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule of ABT-263 in combination with Paclitaxel
Efficacy Assessment
时间窗: Bi-monthly
Evaluate preliminary data regarding objective response rate (ORR), progression free survival (PFS), time to tumor progression (TTP), overall survival (OS), duration of overall response, and, ECOG performance status
次要结局
未报告次要终点
研究者
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