Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer
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.
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Lisa Hammond, MD
Study Chair
University of Texas Health Science Center at San Antonio
United States: Food and Drug Administration
CDR0000066939
NCT00003796
May 1999
Name | Location |
---|---|
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |