NCT01682473已完成1 期
A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants with dose-limiting toxicities
研究概览
简要总结
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.
详细描述
Open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (Arm 1: cycles of 5 days on drug and 2 days off drug), Arm 2: cycles of 21 days on drug and 7 days off drug).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese males or females >= 20 years old
- •Advanced (metastatic or unresectable) solid tumor
- •ECOG performance status score of 0 or 1 and expected survival >12 weeks
- •Recovered from hematological toxicities of prior cancer therapies
排除标准
- •Previous treatment with PI3K inhibitor
- •Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease.
- •Other investigational agent within previous 4 weeks
- •Participating in another clinical study
研究组 & 干预措施
Arm 1: 5/2 Dosing
Experimental
Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug.
干预措施: ZSTK474 (Drug)
Arm 2: 21/7 Dosing
Experimental
Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug.
干预措施: ZSTK474 (Drug)
结局指标
主要结局
Number of participants with dose-limiting toxicities
时间窗: 28 days
次要结局
- Pharmacokinetics (Cmax, tmax, t½, AUC)(28 days)
研究者
研究点 (2)
Loading locations...
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