NCT03076957Unknown1 期
A Phase 1/2a Study to Assess the Safety and Efficacy of CKD-516 Tab. in Combination With Irinotecan Inj. in Patients With Previously Treated Advanced Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose(MTD)
研究概览
简要总结
The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety, tolerability and pharmacokinetic profiles and to assess the efficacy of CKD-516 Tablet in Combination with Irinotecan inj. in Patients with Previously Treated Advanced Colorectal Cancer
详细描述
CKD-516 tab. in combination with Irinotecan inj.(1cycle=14days)
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 19 years or older
- •Patients who failed existing anti-cancer therapies
- •ECOG performance status ≤ 1
- •Life expectancy of ≥ 12 weeks
- •Adequate hematological, hepatic and renal functions:
- •Patients who give written informed consent voluntarily
排除标准
- •Prior systemic chemo-, radiochemo-, radio-, immuno-, hormonal and/or biological therapy within 2 weeks before study participation (in case of nitrosoureas and/or mitomycin, within 6 weeks before study participation)
- •Patients who received major surgery within 4 weeks before study participation (in case of VATS and/or ONC surgery, within 2 weeks before study participation)
- •Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.)
- •NYHA class III or IV heart failure, uncontrolled hypertension (SBP/DBP > 140/90 mm Hg), other clinically significant cardiovascular abnormalities at investigator's discretion (e.g., LVEF < 50%, clinically significant cardiac wall abnormalities or cardiac muscle damages)
- •Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months
- •Uncontrolled arrhythmia
- •Significant cerebrovascular diseases including stroke within 6 months
- •Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases
- •Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease
- •Patients who cannot receive IP by mouth and have a history of clinically significant gastrointestinal disorders which can impede administration, transit or absorption of the IP
- •A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP
- •Pregnancy or breast-feeding
- •Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 3 months after the end of treatment
- •Patients who received other investigational products or used other investigational devices within 3 weeks before participation
- •Patients who cannot participate in this trial by investigator's discretion
研究组 & 干预措施
Treat Regimen
Experimental
CKD-516(investigational Drug) Irinotecan
干预措施: CKD-516 Tablet (Drug)
结局指标
主要结局
Maximum Tolerated Dose(MTD)
时间窗: Up to 14 days(for 1st cycle)
次要结局
- Pharmacokinetics(Cmax)(1st Cycle Day1: up to 24hr)
- Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year(through study completion, an average of 1 year)
研究者
研究点 (1)
Loading locations...
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