A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Percentage of Patients in Non-progression at 2 Months
研究概览
简要总结
RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well efavirenz works as second-line therapy in treating patients with metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy of efavirenz as second-line monotherapy, in terms of non-morphological progression at 2 months, in patients with metastatic adenocarcinoma of the pancreas.
Secondary
- Evaluate non-morphological progression in these patients at 4 months.
- Evaluate non-biological progression in these patients at 2 and 4 months.
- Evaluate the quality of life of these patients at 2 and 4 months.
- Evaluate the overall, progression-free, and event-free survival of these patients.
- Evaluate the tolerability and safety profile of efavirenz in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 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
Efavirenz
Efavirenz will be provided by the sponsor as follows: capsule of efavirenz 200 mg. A bottle contains 90 capsules. Investigator will dispense efavirenz to the patients according to the dose adjustment. Each patient will receive efavirenz 600 mg/day until morphological progression. Study drug will be taken every day by oral route at bedtime and in fast condition (1-2 hours far from dinner).
干预措施: Efavirenz 600mg (Drug)
结局指标
主要结局
Percentage of Patients in Non-progression at 2 Months
时间窗: 2 months
Non-progression is defined as partial response, complete response or stable disease according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).Stable disease is defined as no decrease or increase sufficient to qualify as partial response or progression with reference to SLD since the start of treatment. Radiologic assessment was carried out every 8 weeks.
次要结局
- Percentage of Patients in Non-progression at 4 Months(4 months)
- Percentage of Patients in Non-biological Progression at 2 Months(2 months)
- Overall Survival(Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days))
- Event-free Survival(Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days))
- Progression-free Survival(Through Database Cutoff Date of 06-July-2011 ( median follow-up time of 397 days))
- Quality of Life Score(2 months)