跳至主要内容
临床试验/NCT00003796
NCT00003796已完成2 期

Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 1999年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1

研究概览

简要总结

Phase II trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

详细描述

OBJECTIVES:

I. Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven.

II. Assess the qualitative and quantitative toxic effects of this drug in these patients.

III. Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients.

OUTLINE: This is a multicenter study.

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

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm I

Experimental

Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: irofulven (Drug)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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