NCT01193140已完成2 期
An Extension Study to Evaluate the Safety of Veliparib in Combination With Temozolomide in Subjects With Solid Tumors.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To evaluate the safety and tolerability of veliparib/TMZ combination in subjects with solid tumors
研究概览
简要总结
To evaluate the safety and tolerability of the veliparib/TMZ combination in subjects with solid tumors.
详细描述
An extension study to evaluate the safety of veliparib in combination with temozolomide 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Experimental
干预措施: veliparib (Drug)
Arm A
Experimental
干预措施: Temozolomide (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of veliparib/TMZ combination in subjects with solid tumors
时间窗: Continuous starting with Day1 and 30 Days following last dose.
Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments
次要结局
- To assess effect of veliparib/TMZ combination regimen on progression free survival, overall survival, the objective response rate, time to progression and Eastern Cooperative Oncology Group (ECOG) performance status in subjects with solid tumors(Every 12 weeks from Day1 and continuing up to 18 months following last dose.)
研究者
研究点 (2)
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