Phase I Study of BMS-188797 in Patients With Advanced Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose, dose
limiting toxicities, and safety of BMS-188787 in patients with nonhematologic malignancies.
II. Determine the plasma pharmacokinetics of BMS-188797 in these patients. III. Describe any
antitumor activity of this treatment in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-188797 IV over 1 hour.
Treatment continues every 21 days in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-188797 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicities. Patients are followed every 4 weeks until
toxicities resolve, and then at the investigator's discretion.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study over 12-18
Primary Purpose: Treatment
William S. Dalton, MD, PhD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government