Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- The number of patients who suffer adverse events
研究概览
简要总结
Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
- •ECOG Performance Status of 0 to
- •Adequate organ function as defined by study-specified laboratory tests.
- •Signed informed consent form.
- •Willing and able to comply with study procedures.
排除标准
- •Previous chemotherapy or target therapy.
- •Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
- •Systemically active steroids.
- •Another investigational product within 28 days prior to receiving study drug.
- •Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
- •Infection with HIV, hepatitis B or C at screening.
- •Pregnant or lactating.
- •Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.
研究组 & 干预措施
icotinib plus gemcitabine
Three dose of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.
Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.
干预措施: icotinib (Drug)
icotinib plus gemcitabine
Three dose of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.
Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
The number of patients who suffer adverse events
时间窗: 24 months
次要结局
- Tumor response assessed by RECIST 1.1(3 months)
- Progression-free survival(4 months)