Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.
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
- Double (Participant, Investigator)
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
- •Histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas.
- •Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or
- •Adequate organ function.
排除标准
- •Evidence of metastatic disease.
- •Previous radiotherapy or chemoradiotherapy.
- •History of or current pleural effusion.
- •History of significant cardiovascular disease.
- •Clinically significant bleeding disorder or coagulopathy.
- •Concomitant medication with strong CYP 3A4 inhibitor.
研究组 & 干预措施
Group 2
The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).
干预措施: Placebo (Drug)
Group 1
One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD).
干预措施: dasatinib (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization until date of death from any cause by 02 December 2013
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
次要结局
- Progression Free Survival (PFS)(Time from randomization to earliest PFS event by 02 December 2013)