Phase I Trial of Nelfinavir and Bortezomib in Advanced Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
RATIONALE: Nelfinavir mesylate and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of hematologic cancer by blocking blood flow to the cancer. Giving nelfinavir mesylate together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with bortezomib in treating patients with relapsed or progressive advanced hematologic cancer.
详细描述
OBJECTIVES:
- To assess the safety of nelfinavir mesylate in combination with bortezomib in patients with relapsed or progressive, advanced hematologic malignancies.
- To establish the phase II recommended dose of nelfinavir mesylate in these patients.
OUTLINE: This is a multicenter, dose-escalation study of nelfinavir mesylate.
Patients receive oral nelfinavir mesylate twice daily on days 1-21 and bortezomib IV on days 8, 11, 15, and 18 in course 1. Course 1 has a duration of 28 days. Beginning in course 2, patients receive oral nelfinavir mesylate twice daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for 2 courses. Patients with responding disease may continue to receive nelfinavir mesylate and bortezomib for up to 4 additional courses.
After completion of study treatment, patients are followed for 30 days.
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 —（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
bortezomib + nelfinavir
escalation 3 by 3 cohorts
干预措施: bortezomib (Drug)
bortezomib + nelfinavir
escalation 3 by 3 cohorts
干预措施: nelfinavir mesylate (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: during first cycle
次要结局
- Objective response(during treatment)
- Adverse events according to NCI CTCAE v.4.0(during treatment + 30 days)