Oral ST1481 in Adults With Malignant Glioma: a Phase I-II Clinical Trial

Sigma-Tau Research, Inc.1 个研究点分布在 1 个国家目标入组 59 人开始时间: 2002年3月1日最近更新: 2009年6月3日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Sigma-Tau Research, Inc.
入组人数: 59
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

Gimatecan® is Sigma-Tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound. In addition, we plan to assess the drug's ability to affect the evolution of malignant gliomas, when given as a capsule, rather than by intravenous injection.

研究设计

研究类型: Interventional
分配方式: Non Randomized
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

•Histologically confirmed diagnosis of a recurrent primary malignant glioma
•Life expectancy of at least 3 months with normal hematological, liver and renal function

排除标准

•Pregnant and lactating patients
•Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy
•Gastrointestinal dysfunction that could alter absorption or motility

研究者

发起方

Sigma-Tau Research, Inc.

申办方类型

Industry

研究点 (1)

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