A Phase II Study Of Sunitinib In Combination With Irinotecan, L-leucovorin, And 5-Fluorouracil In Patients With Unresectable Or Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with unresectable or metastatic disease documented on diagnostic imaging studies.
- •Patient must have at least one RECIST-defined measurable lesion that has not been treated with prior local therapy.
排除标准
- •History of another primary malignancy within 3 years prior to study entry, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
- •Current, recent, or planned participation in an experimental treatment drug study other than this protocol.
研究组 & 干预措施
1
干预措施: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil) (Drug)
1
干预措施: Sunitinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 11 cycles (1 cycle = 6 weeks)
PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis.
次要结局
- Overall Survival (OS)(Up to 11 cycles (1 cycle = 6 weeks))
- Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)(Up to 11 cycles (1 cycle = 6 weeks))
- Duration of Response (DR)(Up to 11 cycles (1 cycle = 6 weeks))
- Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.(Cycle 1 Day 15)
- Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib(Cycle 1 Day 15)
- Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib(Cycle 1 Day 15)
- Apparent Oral Clearance (CL/F) of Sunitinib(Cycle 1 Day 15)
- Maximum Observed Plasma Concentration (Cmax) of Irinotecan(Cycle 1 Day 15)
- Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan(Cycle 1 Day 15)
- Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan(Cycle 1 Day 15)
- Terminal Phase Elimination Half-life (t1/2) of Irinotecan(Cycle 1 Day 15)
- Clearance of Irinotecan(Cycle 1 Day 15)
- Volume of Distribution at Steady State (Vss) of Irinotecan(Cycle 1 Day 15)
- Plasma Concentration at Steady State (Css) of 5-FU(Cycle 1 Day 15)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE).(Up to 11 cycles (1 cycle = 6 weeks))