Masitinib in Combination With FOLFIRI Versus Masitinib Alone, Versus Best Supportive Care, in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 5
- 主要终点
- Overall survival
研究概览
简要总结
A prospective, multicentre, open-label, randomized, phase 2-3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care, in third or fourth line treatment of patients with metastatic colorectal cancer
详细描述
The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) versus Best Supportive Care in third or fourth line treatment of patients with metastatic colorectal cancer.
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
- •Patient with non-resectable metastatic colorectal cancer with histological or cytological documentation of adenocarcinoma of the colon or rectum.
- •Patient in third line or fourth line of treatment for metastatic colorectal cancer.
- •Patient with measurable lesions according to RECIST criteria (version 1.1).
- •Patient with ECOG equal to or less than
- •Patient with adequate organ function
- •Other inclusion criteria may also apply
排除标准
- •Prior treatment with masitinib, or any other tyrosine kinase inhibitor for the treatment of malignancy, except regorafenib.
- •More than 3 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, with the exception of basal cell carcinoma or cervical cancer in situ.
- •Other exclusion criteria may also apply
研究组 & 干预措施
Masitinib plus FOLFIRI
Masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid).
Masitinib will be prescribed until disease progression (or treatment switch to next line of treatment), death, limiting toxicity or patient consent withdrawal.
干预措施: Masitinib (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 (0S) 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, whichever came first, assessed up to 60 months)
- Survival rates(Every 24 weeks, assessed up to 60 months)