NCT01226407Unknown1 期
Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer
CrystalGenomics, Inc.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose in Single dose
研究概览
简要总结
Open label, single dose and phase I study.
The primary objective: To determine the maximum tolerated dose in Single dose
The secondary objective: to evaluate the toxicity in administration to determine desirable dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to evaluate pharmacokinetic/ pharmacodynamic profile.
详细描述
- Number of Subjects: 28~36, dose escalation (2~6 subject of each step)
- Adverse Events will be coded to preferred therm and body system using the CTCAE
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
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •from 20 years old to 69 years old
- •diagnosed with progressive solid cancer
- •In spite of standard chemotherapies, the efficacy of the treatment or life extension cannot be expected.
- •Evaluated 0-1 of ECOG
- •Expected life duration is within 3 months
排除标准
- •Major surgery except tumor-removal surgery received within 2 weeks of screening.
- •history of CNS metasis
- •hyper-sensitivy of study drug
- •pregancy or lactating
- •administered other HDAC inhibitor within 4 weeks of screening
研究组 & 干预措施
Single Arm for CG200745
Experimental
any progrossive solid cancer
干预措施: CG200745 (Drug)
结局指标
主要结局
To determine the maximum tolerated dose in Single dose
时间窗: On 22 days after administration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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