A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Median time to death (TTD)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed with pancreatic cancer
- •Have failed first line gemcitabine therapy
排除标准
- •Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine.
- •Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases.
研究组 & 干预措施
1
Xeloda
干预措施: capecitabine (Drug)
2
AZD6244
干预措施: AZD6244 (Drug)
结局指标
主要结局
Median time to death (TTD)
时间窗: Data cut off for this analysis was 5th April 2008.
The TTD (days) was calculated as the interval from date of randomisation to date of patient death (from any cause). Patients who had not died at the time of the final analysis were censored at the last date the patient was known to be alive. Median TTD in days is presented here.
次要结局
- Progression event count(The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days))
- To assess the safety and tolerability of AZD6244 in the treatment of advanced or metastatic pancreatic cancer by review of adverse events (AEs) and laboratory parameters.(Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008)