Phase I Study of BMS-247550 Given Every Three Weeks in Patients With Advanced Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicities, safety, and a
recommended phase II dose of BMS-247550 administered as a 1 hour infusion every 3 weeks in
patients with advanced solid tumors. II. Evaluate the plasma pharmacokinetics of this drug
in this patient population. III. Determine any preliminary evidence of antitumor activity of
this drug in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-247550 IV over 1 hour every 3
weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable
toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of
BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 8-12
Primary Purpose: Treatment
David R. Spriggs, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|