NCT01014429已完成1 期
A Phase I Dose Escalation Study of NMS-1286937 Administered to 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 21 人开始时间: 2009年11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
- 21
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.
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/metastatic solid tumors, for which no effective standard therapy exist
- •Adult patients (age >/= 18)
- •ECOG performance status (PS) 0 or 1
- •Life expectancy of at least 3 months
- •Adequate renal, liver function and bone marrow reserve
- •Prior cancer therapy allowed, with max 4 regimens of chemotherapy. Washout: at least 4 wks (6 wks for nitrosoureas, mitomycin C and liposomal doxorubicin) and all toxicities recovered to CTC Grade </=1
- •Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
- •Women and men of child producing potential should agree to use effective contraception
- •Capability to swallow capsules intact
排除标准
- •Known uncontrolled/symptomatic brain metastases
- •Currently active second malignancy
- •Major surgery in the last 4 wks
- •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
- •History of drug allergic reactions
- •Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption.
- •Documented gastrointestinal ulcer
- •Other severe concurrent 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-1286937 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)
时间窗: Cycle 1
次要结局
- Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL), volume of distribution, half-life (t½)(Cycles 1 and 2)
- Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients(Cycles 1 and 2)
研究者
研究点 (1)
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