ONO-4578 Phase I Study An Open-label, Uncontrolled Study of First-line Combination Therapy of ONO-4578 and ONO-4538 With Standard Therapy XELOX Plus Bevacizumab or FOLFOX Plus Bevacizumab in Patients With Unresectable, Advanced or Recurrent Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- Incidence and severity of AEs and SAEs
研究概览
简要总结
To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable colorectal cancer
- •Life expectancy of at least 3 months
- •Patients with ECOG performance status 0 or 1
排除标准
- •Patients with severe complication
- •Patients are unable to swallow oral medications
研究组 & 干预措施
ONO-4578+ONO-4538+XELOX plus bevacizumab
干预措施: ONO-4578 (Drug)
ONO-4578+ONO-4538+XELOX plus bevacizumab
干预措施: ONO-4538 (Drug)
ONO-4578+ONO-4538+XELOX plus bevacizumab
干预措施: Capecitabine (Drug)
ONO-4578+ONO-4538+XELOX plus bevacizumab
干预措施: Oxaliplatin (Drug)
ONO-4578+ONO-4538+XELOX plus bevacizumab
干预措施: Bevacizumab (Drug)
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
干预措施: ONO-4578 (Drug)
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
干预措施: ONO-4538 (Drug)
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
干预措施: Oxaliplatin (Drug)
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
干预措施: Fluorouracil (Drug)
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
干预措施: Calcium Levofolinate Hydrateb (Drug)
ONO-4578+ONO-4538+FOLFOX plus bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Incidence and severity of AEs and SAEs
时间窗: up to 3years
Incidence and severity of clinical laboratory abnormalities
时间窗: up to 3years
12-lead electrocardiography (Heart rate)
时间窗: up to 3years
12-lead electrocardiography (PR interval)
时间窗: up to 3years
12-lead electrocardiography (RR interval)
时间窗: up to 3years
12-lead electrocardiography (QRS width)
时间窗: up to 3years
12-lead electrocardiography (QT interval)
时间窗: up to 3years
Chest X-ray test
时间窗: up to 3years
ECOG performance status
时间窗: up to 3years
次要结局
- Objective response rate (ORR)(up to 3years)
- Disease control rate (DCR)(up to 3years)
- Overall survival (OS)(up to 3years)
- Progression-free survival (PFS)(up to 3years)
- Duration of response (DOR)(up to 3years)
- Time to response (TTR)(up to 3years)
- Best oveall response (BOR)(up to 3years)
- Percentage of change in the sum of tumor diameters of target lesions(up to 3years)
- Maximum percent change in the sum diameters of the target lesions(up to 3years)
- Time course of tumor markers(up to 3years)
- Plasma ONO-4578 concentration(up to 3years)
- Serum ONO-4538 concentration(up to 3years)
- Anti-ONO-4538 antibody(up to 3years)