NCT00887757已完成1 期
A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Gemzar® (Gemcitabine) in the Treatment of Subjects With Solid Tumors
AbbVie0 个研究点目标入组 46 人开始时间: 2009年9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
- 46
- 主要终点
- Assess the safety profile of ABT-263 in combination with gemcitabine.
研究概览
简要总结
This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when combined with a standard regimen of gemcitabine in approximately 50 subjects with solid tumors and measurable disease.
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
gemcitabine +ABT-263
Experimental
干预措施: ABT-263 (Drug)
gemcitabine +ABT-263
Experimental
干预措施: gemcitabine (Drug)
结局指标
主要结局
Assess the safety profile of ABT-263 in combination with gemcitabine.
时间窗: Weekly
Study the pharmacokinetic interaction between ABT-263 and gemcitabine.
时间窗: Weekly
Determine the maximum tolerated dose (MTD) of ABT-263 in combination with gemcitabine.
时间窗: Weekly
次要结局
- Evaluate preliminary data regarding progression free survival (PFS)(Bi-monthly)
- Evaluate preliminary data regarding objective response rate (ORR)(Bi-monthly)
- Evaluate preliminary data regarding time to tumor progression (TTP)(Bi-monthly)
- Evaluate preliminary data regarding overall survival (OS)(Bi-monthly)
- Evaluate biomarkers to(Bi-monthly)
- Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule in combination with a standard and weekly regimen of gemcitabine.(Bi-monthly)
- Evaluate preliminary data regarding duration of overall response(Bi-monthly)
- Evaluate preliminary data with Eastern Cooperative Oncology Group (ECOG) performance status(Bi-monthly)
研究者
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