NCT00553696已完成1 期
A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic 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
- 27
- 试验地点
- 3
- 主要终点
- Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)
研究概览
简要总结
To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of gastric cancer
- •Chemonaive patients
- •Adequate organ function
排除标准
- •Patients who meet the contra-indications of S-1 and Cisplatin.
- •Prior chemotherapy failure patients
研究组 & 干预措施
A
Experimental
干预措施: Cisplatin (Drug)
A
Experimental
干预措施: S-1 (Drug)
A
Experimental
干预措施: Sunitinib (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 Week 4)
A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)(Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose))
- Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU(Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose))
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)(Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose))
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU(Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose))
- Progression-Free Survival (PFS)(Baseline up to 739 days)
- Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)(Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose))
- Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum(Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion))
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum(Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion))
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU(Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose))
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum(Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion))
- Number of Participants With Objective Response(Baseline up to 739 days)
- Number of Participants With Clinical Benefit Response (CBR)(Baseline up to 739 days)
- Duration of Response (DR)(Baseline up to 739 days)
- Time to Progression (TTP)(Baseline up to 739 days)
研究者
研究点 (3)
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