Phase I Study of BMS-184476 in Patients With Advanced Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended
phase II dose, and safety of BMS-184476 in patients with advanced solid tumors. II.
Determine the pharmacokinetic profile of BMS-184476 and its metabolites in these patients.
III. Determine preliminary evidence of antitumor activity of BMS-184476 in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive BMS-184476 IV over 1
hour. Treatment is repeated every 21 days in the absence of disease progression or
unacceptable toxicity. In the second part of the study, patients receive BMS-184476 IV over
1 hour weekly. Cohorts of 3-6 patients are treated at escalating doses of BMS-184476. The
maximum tolerated dose is defined as the dose at which fewer than 2 of 6 patients experience
dose limiting toxicity. Patients are followed every 4 weeks until toxicity is resolved.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 12-18
Primary Purpose: Treatment
Manuel Hidalgo, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|San Antonio Cancer Institute||San Antonio, Texas 78229-3264|