NCT01092052终止1 期
A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors
Nerviano Medical Sciences1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年1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
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD)
研究概览
简要总结
The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
- •Maximum of 4 regimens of prior cancer therapy allowed
- •Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
- •Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
- •ECOG performance status (PS) 0 or 1
- •Adult (age >/= 18 and </= 80 years) patients
- •Adequate renal, liver and BM reserve
- •Capability to swallow capsules intact
排除标准
- •Current enrollment in another therapeutic clinical trial
- •Known brain metastases
- •Currently active second malignancy
- •Major surgery within 4 weeks prior to treatment
- •Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
- •Pregnancy or breast-feeding women
- •Known active infections
- •Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
- •Adrenal insufficiency
- •Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives
研究组 & 干预措施
1
Experimental
干预措施: NMS-1116354 (Drug)
结局指标
主要结局
First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD)
时间窗: 3 weeks
次要结局
- Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½)(6 weeks)
研究者
研究点 (1)
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