NCT03081819已完成1 期
A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer
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
- 11
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer.
The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated.
The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated.
The third dose group receives SH003 for 3 weeks.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years or older
- •Patients with histologically and cytologically confirmed solid tumor
- •Patients who have failed standard treatments, such as previous chemotherapy or radiotherapy, or who are inoperable, refractory, or progressive.
- •ECOG score 0-2
- •Patients with a minimum life expectancy of 12 weeks at the scheduled starting date of the study drug
- •Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.
- •Patients who can swallow pills.
- •Patients who provide written informed consent for participation in the trial
排除标准
- •Known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, or Trichosanthes Kirilowii Maximowicz
- •Patients with pre-existing cardiac conditions:
- •Prior documented myocardial infarction within the last 6 months
- •Pre-existing cardiac failure (NYHA class III-IV)
- •Atrial fibrillation on anti-coagulants
- •Unstable angina
- •Severe valvulopathy
- •Cardiac angioplasty or stenting with in the last 6 months
- •Pregnant or lactating females
- •Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety
- •Active uncontrolled infection, including known history of AIDS or hepatitis B or C
- •Any psychological, sociological, or geographical condition that could potentially interfere with compliance with the study protocol
- •Concurrently receiving any other investigational agents while on study
研究组 & 干预措施
SH003
Experimental
Participant will take SH003 for 3 weeks.
干预措施: SH003 (Drug)
结局指标
主要结局
Adverse events
时间窗: 3 weeks
Grade 3-4 adverse event using CTCAE v4.03
次要结局
未报告次要终点
研究者
Seong-Gyu Ko
Professor
Kyunghee University Medical Center
研究点 (1)
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