A Phase I/II Study of the Safety and Efficacy of Brostallicin (PNU-166196A) in Adult Patients With Multiple Myeloma That Has Progressed on Prior Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Objective Tumor Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as brostallicin use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of brostallicin in treating patients who have recurrent or refractory multiple myeloma.
详细描述
OBJECTIVES:
- Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the time to and duration of response, time to treatment failure, time to tumor progression, and survival in patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Correlate baseline whole blood levels and activity of glutathione with clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
- Phase I: Patients receive brostallicin IV over 10-30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of brostallicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
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
Brostallicin
干预措施: brostallicin (Drug)
结局指标
主要结局
Objective Tumor Response Rate
时间窗: 1 year
• Determine the objective tumor response rate (confirmed complete response and confirmed partial response) of brostallicin in patients with recurrent or refractory multiple myeloma
次要结局
- Time to treatment failure(1 year)
- Time to tumor progression(1 year)
- Time to response(1 year)
- Duration of Response(1 year)
- Maximum Tolerated Dose of brostallicin(1 year)
- Overall Survival(1 year)