NCT00663741已完成1 期
Phase I Study to Investigate Safety, Pharmacokinetics and Preliminary Efficacy Profile of Sorafenib (BAY 43-9006) in Combination With S-1 Plus CDDP in Asian Patients With Unresectable / Recurrent 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
- Bayer
- 入组人数
- 13
- 主要终点
- Safety and pharmacokinetics
研究概览
简要总结
This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable / recurrent gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmation of the primary unresectable or recurrent gastric cancer (both with and without measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) are allowed). Peritoneal dissemination without ascites is allowed.
- •No prior systemic anticancer therapy including chemotherapy, immunotherapy, targeted agents or experimental therapies for advanced disease
- •Prior adjuvant therapy/neo adjuvant therapy is allowed if recurrence occurred 6 months after completion of these therapies
- •Age >/= 18 years and < 75 years
排除标准
- •Known brain metastasis, spinal cord compression or meningeal carcinomatosis.
- •Clinically relevant ascites
- •Concurrent cancer that is distinct in primary site or histology from gastric cancer
- •Any condition that impairs patient's ability to swallow whole pills
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Arm 2
Experimental
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Arm 3
Experimental
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Safety and pharmacokinetics
时间窗: 20 weeks after start of treatment
次要结局
- 1 year survival rate(1 year after start of treatment)
- Overall survival(1 year after start of treatment)
- Progression free survival(1 year after start of treatment)
- Response rate(1 year after start of treatment)
- Duration of response(Time from initial Response to documented Tumor Progression)
研究者
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