Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 6-month overall survival
研究概览
简要总结
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling.
详细描述
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling.
Patients with BRCA2 gene will be treated with Mitomycin-C (MMC) on Day 1 at a dose of 10mg/m2 intravenously. This will be repeated every 28 days, which is one cycle. Expected adverse events and appropriate dose modifications are described in this section. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2.
Primary Objectives:
- To determine the 6-month survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are treated with single agent Mitomycin-C (MMC) chemotherapy.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（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
Arm 1
Patients with BRCA2 gene will be treated with Mitomycin-C (MMC) on Day 1 at a dose of 10mg/m2 intravenously. This will be repeated every 28 days, which is one cycle. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2
干预措施: Mitomycin-C (Drug)
结局指标
主要结局
6-month overall survival
时间窗: up to 6 months
Number of participants with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are alive after 6-months after being treated with single agent Mitomycin-C (MMC) chemotherapy.
次要结局
- Response rate(up to 2.5 years)
- Progression-free survival at 6 months(up to 6 months)
- Progression-free survival(up to 2.5 years)
- Overall survival(up to 2.5 years)
- Toxicity as assessed by number of participants experiencing adverse events.(Up to 2.5 years)
- To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population.(2.5 years)