NCT02210663已完成1 期
A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
AbbVie3 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014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
- 16
- 试验地点
- 3
- 主要终点
- Dose-limiting toxicities of veliparib
研究概览
简要总结
This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed malignant solid tumor, and any of the following: * Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; * Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; * Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Life expectancy of greater than 12 weeks.
- •Adequate organ and marrow function· Measurable or non-measurable disease.
排除标准
- •Major surgery and/or radiation within (<) 4 weeks prior to study enrollment.
- •Chemotherapy or hormone therapy within (<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks.
- •Any investigational agents within (<) 4 weeks prior to study enrollment.
- •Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.
- •Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.
研究组 & 干预措施
veliparib (ABT-888)
Experimental
干预措施: veliparib (ABT-888) (Drug)
结局指标
主要结局
Dose-limiting toxicities of veliparib
时间窗: During the first cycle (28 days) of veliparib administration
次要结局
- Change in participant physical exam measurements(Approximately 1 year)
- Change in participant clinical lab results(Approximately 1 year)
- Number of participants with adverse events(Approximately 1 year)
- Preliminary tumor response(Participants will be followed for the duration of an expected average of 8 months.)
- Maximum observed plasma concentration (Cmax)(For 24 hours following veliparib dosing.)
- The time to Cmax (peak time, Tmax)(For 24 hours following veliparib dosing.)
- The area under the plasma concentration-time curve (AUC)(For 24 hours following veliparib dosing.)
研究者
研究点 (3)
Loading locations...
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