NCT00888108已完成1 期
A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Taxotere® (Docetaxel) in the Treatment of Subjects With Solid Tumors
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
- Abbott
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Assess the safety profile of navitoclax (ABT-263) when administered in combination with a standard and weekly regimen of docetaxel.
研究概览
简要总结
This is a Phase 1 open-label study evaluating the safety of ABT-263 when combined with a standard and weekly regimen of docetaxel in subjects who have solid tumors with 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 —（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
docetaxel +ABT-263
Experimental
干预措施: ABT-263 (Drug)
docetaxel +ABT-263
Experimental
干预措施: Docetaxel (Drug)
结局指标
主要结局
Assess the safety profile of navitoclax (ABT-263) when administered in combination with a standard and weekly regimen of docetaxel.
时间窗: Weekly
Study the pharmacokinetic interaction of navitoclax (ABT-263) and docetaxel
时间窗: Weekly
Determine the maximum tolerated dose (MTD) of navitoclax (ABT-263) with a standard regimen of docetaxel
时间窗: Weekly
Determine the MTD of both navitoclax and docetaxel with a weekly schedule.
时间窗: Weekly
次要结局
- Evaluate preliminary data regarding progression free survival(Bimonthly)
- Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule in combination with a standard and weekly regimen of docetaxel.(Bimonthly)
- Evaluate preliminary data regarding objective response rate(Bimonthly)
- Evaluate preliminary data regarding overall survival(Bimonthly)
- Evaluate preliminary data regarding duration of overall response(Bimonthly)
- Evaluate preliminary data with Eastern Cooperative Oncology Group (ECOG) performance status(Bimonthly)
- Evaluate biomarkers(Bimonthly)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
1 期
A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid MalignanciesChronic Lymphoid LeukemiaLymphoid MalignanciesNon-Hodgkin's LymphomaPeripheral T-cell LymphomaMantle Cell LymphomaFollicular LymphomaNCT00406809AbbVie (prior sponsor, Abbott)81
已完成
1 期
A Phase 1/2a Study of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological MalignanciesSmall Cell Lung CarcinomaSmall Cell Lung CancerNCT00445198AbbVie (prior sponsor, Abbott)86
已完成
1 期
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT00481091AbbVie60
已完成
1 期
Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT00868413AbbVie (prior sponsor, Abbott)32
已完成
1 期
Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid TumorsSolid TumorsNCT00887757AbbVie46