A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-label Phase I Part to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With FOLFOX Followed by a Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib (AZD2171) in Combination With FOLFOX
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it's better than giving standard treatment alone in helping to prevent progression of mCRC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Metastatic colorectal cancer
- •WHO performance status 0-1
- •Life expectancy is 12 weeks or longer
排除标准
- •Patient with uncontrolled brain metastases
- •Patient with inappropriate laboratory tests values
- •Patient with poorly controlled hypertension
研究组 & 干预措施
FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 20 mg
干预措施: AZD2171 (Drug)
FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 20 mg
干预措施: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) (Drug)
FOLFOX + Cediranib 30 mg
FOLFOX + Cediranib 30 mg
干预措施: AZD2171 (Drug)
FOLFOX + Cediranib 30 mg
FOLFOX + Cediranib 30 mg
干预措施: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) (Drug)
FOLFOX + Placebo Cediranib
FOLFOX + Placebo Cediranib
干预措施: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) (Drug)
FOLFOX + Placebo Cediranib
FOLFOX + Placebo Cediranib
干预措施: Placebo Cediranib (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)
Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
次要结局
- Objective Tumour Response Rate(RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups))
- Best Percentage Change in Tumour Size(Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups))
- Duration of Response(RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups))
- Overall Survival(Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups))