NCT02191761已完成1 期
Phase1, Open-Label, Dose Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic 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
- 13
- 主要终点
- Determine the MTD
研究概览
简要总结
This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.
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
- •Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer
- •Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, or radiotherapy
- •Subjects must meet certain laboratory criteria
- •Expected survival > 3months
- •Subjects must have no uncontrolled intercurrent illness
排除标准
- •Women who are pregnant or lactating, or who are of childbearing potential , and men who do not use a barrier method
- •Subjects with significant cardiac issues
- •Subjects using certain medications
- •Subjects with certain medical conditions
- •Subjects with brain metastasis
- •Subjects who have recently been enrolled in other experimental clinical trials of investigational agents
研究组 & 干预措施
SM04755
Experimental
干预措施: SM04755 (Drug)
结局指标
主要结局
Determine the MTD
时间窗: 28 days
次要结局
- Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)(8 weeks)
- Half Life of SM04755(30 Days)
- Total Clearance of SM04755 after oral administration(30 days)
- Maximum Observed Plasma Concentration (Cmax) of SM04755(30 Days)
- Accumulation ratio of SM04755(30 Days)
- Area under the plasma concentration (AUC) Versus Time Curve of SM04755(30 days)
- Volume of Distribution of SM04755(30 Days)
- Time to maximum plasma concentration(30 Days)
- Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings(28 days)
研究者
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