NCT00519662已完成1 期
Phase 1 Open-Label Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of SNS-314, a Novel Aurora Kinase Inhibitor, Administered to Patients With Advanced Solid Tumors
Sunesis Pharmaceuticals4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2007年8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
- 32
- 试验地点
- 4
- 主要终点
- To assess the safety and tolerability of SNS-314
研究概览
简要总结
This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.
详细描述
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced solid tumor and that is measurable by a scan
排除标准
- •Uncontrolled or untreated central nervous system metastases
- •Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1
- •Any of the following cardiac conditions:
- •History of myocardial infarction, acute coronary syndromes up to 12 weeks before Cycle 1 Day 1
- •Class III or IV heart failure up to 6 months before Cycle 1 Day 1
- •Baseline heart rate corrected QT interval (QTc)> 450 msec
- •History of ventricular arrhythmias up to 6 months before Cycle 1 Day 1
- •Use of medications that prolong the QTc interval and are associated with Torsades de Pointe (TdP)
- •Previous cancer treatment up to 21 days before first dose
- •Any investigational therapy up to 28 days before Cycle 1 Day 1
- •Known allergy to cyclodextrins
- •Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.
研究组 & 干预措施
Dose escalating cohorts of SNS-314
Experimental
Sequential groups, starting at a dose of 30 mg/m2, will be escalated according to identification of dose limiting toxicities against various criteria. Doses escalated by doubling the dose until the first observation of clinically significant Grade 2 or greater toxicity related to SNS-314 injection. Results in dosing increments of 67%, 50%, 40%, 33%, and subsequently 25% based on modified Fibonacci schema.
干预措施: SNS-314 (Drug)
结局指标
主要结局
To assess the safety and tolerability of SNS-314
时间窗: 1 Year
次要结局
未报告次要终点
研究者
研究点 (4)
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