NCT00555672已完成1 期
A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric 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
- 发起方
- Pfizer
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of stomach cancer
- •advanced stomach cancer stage IV
- •adequate blood chemistry, blood counts and kidney function
- •willing to participate to study requirements and to sign an informed consent document
排除标准
- •prior chemotherapy for stomach cancer in its advanced stage
- •excessive toxicities related to prior therapies
- •pregnant or breastfeeding patients
研究组 & 干预措施
A
Experimental
干预措施: 5-fluorouracil (Drug)
A
Experimental
干预措施: cisplatin (Drug)
A
Experimental
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
时间窗: Cycle 1 (Baseline to Day 21)
The incidence of DLTs assessed during the first cycle (21 days).
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose))
- Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)](Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose))
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose))
- Steady State Concentration (Css) of 5-Fluorouracil (5-FU)(Day 1 of Cycle 1 (2, 4, and 6 hours post infusion))
- Infusion Rate (Zero Order) (R0) of 5-FU(Day 1 of Cycle 1 (2, 4, and 6 hours post infusion))
- Clearance (CLss) of 5-FU(Day 1 of Cycle 1 (2, 4, and 6 hours post infusion))
- Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU(Day 1 of Cycle 1 (2, 4, and 6 hours post infusion))
- Number of Participants With Objective Response(Baseline, Day 21 of every even-numbered cycle up to 15 Months)
- Duration of Response (DR)(Baseline up to Month 15)
- Progression-Free Survival (PFS)(Baseline up to Month 15)
研究者
研究点 (1)
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