A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With Cisplatin Plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients With Previously Untreated Locally Advanced or Metastatic Unresectable Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.
研究概览
简要总结
The primary objective of the study is to assess the safety and tolerability of cediranib in combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese patients with previously untreated locally advanced or metastatic unresectable gastric cancer (GC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histological or cytological confirmation of gastric adenocarcinoma (including the gastric cardia and esophagogastric junction)
- •Having locally advanced or metastatic gastric cancer for which they must have received no prior systemic therapy for locally advanced disease. Previous gastrectomy, neoadjuvant and adjuvant therapy received > 6 months ago are acceptable
- •Having a mild symptom in ordinal daily lives including walking and simple labour or works in the sitting position
排除标准
- •A history of poorly controlled hypertension or resting BP > 150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy or patients who are requiring maximal doses of calcium channel blockers to stabilize BP
- •Significant Haemorrhage (> 30 ml bleeding/episode in previous 3 months) or haemoptysis (> 5 ml fresh blood in previous 4 weeks)
- •Arterial thromboembolic event (including ischemic attack) in the previous 12 months
研究组 & 干预措施
Treatment A
Cediranib 20mg + Cisplatin + S-1
干预措施: Cediranib (Drug)
Treatment A
Cediranib 20mg + Cisplatin + S-1
干预措施: Cisplatin (Drug)
Treatment A
Cediranib 20mg + Cisplatin + S-1
干预措施: S-1 (Drug)
Treatment B
Cediranib 20mg + Cisplatin + Capecitabine
干预措施: Cediranib (Drug)
Treatment B
Cediranib 20mg + Cisplatin + Capecitabine
干预措施: Cisplatin (Drug)
Treatment B
Cediranib 20mg + Cisplatin + Capecitabine
干预措施: Capecitabine (Drug)
结局指标
主要结局
Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.
时间窗: Cycle 1 of each treatment arm
次要结局
- Pharmacokinetics will be assessed in terms of Css,max, Css,min, tmax, AUCss and AUC0-8 for cediranib, and Cmax, tmax, AUC, AUC(0-t), CL or CL/F, t½λz for capecitabine, cisplatin and TS-1. Additional PK parameters may be determined.(Cycle 1 and 2 of each treatment arm)