NCT00073892已完成1 期
A Phase I/II Study Of PI-88 In Advanced Malignancies (Phase I), And In Advanced Melanoma(Phase II)
Cellxpert Biotechnology Corp.5 个研究点 分布在 2 个国家目标入组 44 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Efficacy Analysis
研究概览
简要总结
RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy (cancer) or stage IV melanoma.
详细描述
OBJECTIVES:
Phase I
- Determine the maximum tolerated dose of PI-88 in patients with an advanced malignancy.
- Determine the safety and tolerability of this drug in these patients.
Phase II
- Determine the progression-free survival and time to progression in patients with stage IV melanoma treated with this drug.
- Determine the biological activity of this drug 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
PI-88
Experimental
Patients receive four consecutive days treatment each week in a 4-week cycle.
干预措施: PI-88 (Drug)
结局指标
主要结局
Efficacy Analysis
时间窗: end of Cycle 6 of study treatment (24 weeks)
non-progression rate (objective response or stable disease)
次要结局
- Efficacy Analysis(were time to progressive disease, survival, duration of partial response, complete response and stable disease)
研究者
研究点 (5)
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