A Phase Ib, Multi-center, Open-label Study of Z650 and Gemcitabine in Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Rate of dose limiting toxicities of each subject
研究概览
简要总结
This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.
详细描述
This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.This phase IB trial is Multi-center and open。
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease.
排除标准
- •adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound evaluation of Left ventricular ejection fraction < 50%
研究组 & 干预措施
z650 and Gemcitabine
Z650:250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal Gemcitabine: intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle FOR the 4-6 cycles
干预措施: Z650 (Drug)
z650 and Gemcitabine
Z650:250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal Gemcitabine: intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle FOR the 4-6 cycles
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Rate of dose limiting toxicities of each subject
时间窗: 21 days
Rate will be assessed through summaries of adverse events, clinical laboratory abnormalities, and changes in physical exam and vital signs. All subjects who receive a single dose of study medication will be considered evaluable for safety.
次要结局
- Adverse events related to pulse dose Z650 and gemcitabine(up to 4 weeks after last dose)
- Disease Control Rate (DCR)(up to approximately 24 months)
- Overall Survival (OS)(up to approximately 24 months)
- Duration of Response (DOR)(up to approximately 24 months)
- Overall response rate (ORR)(up to approximately 24 months)
- Progression-free Survival (PFS)(up to approximately 24 months)