NCT00349167已完成1 期
A Phase I, Multi-Center, Open Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given Every 3 Weeks in Patients With Solid Tumors
Proacta, Incorporated1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2005年12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
- 27
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Evaluate the safety and tolerability of PR-104 in patients with advanced solid tumors.
- Determine the maximum tolerated dose of PR-104 in these patients.
Secondary
- Characterize the pharmacokinetics of PR-104 and its alcohol metabolite in these patients.
- Assess evidence of antitumor 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 —（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
PR-104
Experimental
PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2
干预措施: PR-104 (Drug)
PR-104
Experimental
PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2
干预措施: laboratory biomarker analysis (Other)
PR-104
Experimental
PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2
干预措施: pharmacological study (Other)
研究者
研究点 (1)
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