NCT02552953已完成1 期
A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
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
- 60
- 试验地点
- 1
- 主要终点
- Number of patients who experience dose-limiting toxicities
研究概览
简要总结
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
详细描述
This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- •18 years or older
- •ECOG performance status 0-1
- •Life expectancy ≥ 3 months
- •Evaluable disease
- •Adequate organ functions
- •4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
- •At least 4 weeks from major surgery
- •Agree to practice effective contraception
- •Agree to follow protocol required evaluations
- •Ability to understand and willingness to sign the informed consent form
排除标准
- •Previously untreated CNS metastasis or progressive 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
CYC065 - 4 hour infusion (Part 1 completed)
Experimental
CYC065 will be administered by 4 -hour infusion every 3 weeks.
干预措施: CYC065 (Drug)
CYC065 - 1 hour infusion (Part 2 - ongoing)
Experimental
CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks
干预措施: CYC065 (Drug)
CYC065 - Oral (Part 3 - ongoing)
Experimental
CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks
干预措施: CYC065 (Drug)
结局指标
主要结局
Number of patients who experience dose-limiting toxicities
时间窗: cycle 1(each cycle is 21 -28 days)
次要结局
- Half-life of CYC065(cycle 1(each cycle is 21 -28 days))
- changes in certain protein levels in peripheral white blood cells by western blots(cycle 1(each cycle is 21 -28 days))
- Plasma concentrations(cycle 1(each cycle is 21 -28 days))
研究者
研究点 (1)
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