A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)
研究概览
简要总结
This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in addition to standard chemotherapy in the 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis;
- •At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI);
- •Aged 20 years old or above;
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2;
- •Adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L);
- •Adequate renal and hepatic functions: total bilirubin < 1.25 x upper normal limit, creatinine < 1.25 x upper normal limit, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x upper normal limit;
- •Patients willing to participate in the trial and giving written informed consent.
排除标准
- •Pregnant or lactating patients;
- •Patients (male or female) with reproductive potential not using adequate contraceptive measures;
- •Patients with evidence of central nervous system metastasis;
- •Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents
- •Current history of chronic diarrhea;
- •Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction);
- •History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- •Concurrent treatment with any other anticancer therapy;
- •Patients with congestive heart failure (New York Heart Association Functional Classification III or IV), epilepsy, or other significant medical conditions as judged by the investigator;
- •Patients treated with another investigational drug within 4 weeks of entry into this study.
研究组 & 干预措施
MB-6+FOLFOX4
MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
干预措施: MB-6 (Drug)
Placebo+FOLFOX4
Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)
时间窗: 16 weeks
The primary efficacy analysis, the incidence of best overall response during the study period, was based on the Fisher's exact test for the binary response that was used to test for the differences in the treatment efficacy between MB-6 and Placebo.
次要结局
未报告次要终点