NCT02605044终止3 期
A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With FOLFIRI (Irinotecan, 5-fluorouracil and Folinic Acid) to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer
AB Science3 个研究点 分布在 3 个国家目标入组 123 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 123
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients.
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
- •Patient with non-resectable metastatic colorectal cancer
- •Metastatic disease not amenable to surgical resection
- •Patient in second line treatment after progression according to RECIST criteria
- •Patient with measurable lesions according to RECIST criteria (version 1.1)
- •Patient eligible for a standard second line treatment with FOLFIRI
- •Patient with ECOG ≤ 2
- •Patient with adequate organ function
- •Patient with life expectancy > 3 months
- •Female or male patient ≥ 18
- •Patient weight > 40 kg and BMI > 18
排除标准
- •Patient who cannot receive FOLFIRI
- •More than 1 prior chemotherapy regimens for metastatic colorectal cancer
- •Pregnant, intent to be pregnant, or nursing female patient
- •Patient with any chronic inflammatory bowel disease
- •Patient treated for a cancer other than colorectal cancer within five years before enrollment
- •Patient with an hepatic involvement > 50%
- •Patient with active central nervous system (CNS) metastasis or history of CNS metastases
- •Patient with an active infection
- •Patient presenting with cardiac disorders
- •Any previous treatment with an investigational agent or chemotherapy or biological agent within four weeks prior to baseline.
研究组 & 干预措施
Masitinib + FOLFIRI
Experimental
masitinib + FOLFIRI
干预措施: Masitinib (AB1010) (Drug)
Masitinib + FOLFIRI
Experimental
masitinib + FOLFIRI
干预措施: FOLFIRI (Drug)
Placebo + FOLFIRI
Placebo Comparator
Placebo + FOLFIRI
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Overall survival
时间窗: From day of randomization to death, assessed for a maximum of 60 months
Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.
次要结局
- Progression Free Survival (PFS)(From day of randomization to disease progression or death, assessed for a maximum of 60 months)
- Survival rate(Every 24 weeks, assessed up to 60 months)
研究者
研究点 (3)
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