A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)
试验速览
- 阶段
- 3 期
- 入组人数
- 250
- 试验地点
- 60
- 主要终点
- Overall Survival
研究概览
简要总结
A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)
详细描述
Purpose:
The purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.
Who is it for:
You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.
Trial Details:
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
- Triple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Regorafenib
Regorafenib 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression
干预措施: Regorafenib (Drug)
Placebo
Placebo 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression
干预措施: Placebo (Other)
结局指标
主要结局
Overall Survival
时间窗: From time of patient randomisation until date last known alive (up to 12 months following end of treatment).
The interval from the date of randomisation to date of death from any cause, or the date last known alive.
次要结局
- Progression Free Survival(From time of patient randomisation until first evidence of disease progression or death (up to 12 months following randomisation).)
- Evaluation of health states experienced by participants(From time of commencement of treatment until first evidence of disease progression (up to 12 months following commencement of treatment).)
- Objective Tumour Response Rate(From time of patient randomisation until evidence of complete or partial response (up to 12 months following randomisation).)
- Rates of Adverse Events(From time dose of study treatment until 30 days after last dose of study treatment)