NCT00560716终止1 期
A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced solid tumors.
详细描述
Phase I study of an investigational cancer drug, CYC116, an Aurora kinase inhibitor, in patients 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incurable advanced solid tumors that did not respond to conventional therapy or for which no effective therapy exists
- •Age >=18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy ≥ 3 months
- •Evaluable disease
- •Adequate bone marrow function
- •Adequate renal function
- •Adequate liver function
- •At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
- •Able to swallow capsules
- •At least 3 weeks from major surgery
- •Agree to practice effective contraception
排除标准
- •Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
- •Currently receiving radiotherapy, biological therapy, or any other investigational agents
- •Uncontrolled intercurrent illness
- •Pregnant or lactating women
- •Known to be HIV-positive
- •Known active hepatitis B and/or hepatitis C infection
研究组 & 干预措施
CYC116
Experimental
CYC116 dose escalation first-in-human evaluation
干预措施: CYC116 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: over the course of study
Safety and tolerability; SAEs and AEs
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced CancersCancerNCT02552953Cyclacel Pharmaceuticals, Inc.60
已完成
1 期
A Study of ARRY-334543 in Patients With Advanced CancerAdvanced CancerNCT00637702Array Biopharma, now a wholly owned subsidiary of Pfizer31
尚未招募
1 期
A Study of QL1706H in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT06047431Qilu Pharmaceutical Co., Ltd.150
已完成
1 期
A Study of TAS-116 in Patients With Solid TumorsAdvanced Solid TumorsNCT02965885Taiho Oncology, Inc.31
已完成
1 期
A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid TumourSolid TumorsNCT00778128Clavis Pharma26