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