Phase I Study of BMS-214662 Oral Dosing in Patients With Advanced Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicity, recommended
phase II dose, and safety of BMS-214662 in patients with advanced solid tumors. II.
Determine the pharmacokinetics of BMS-214662 in these patients. III. Assess the absolute
oral bioavailability of BMS-214662 using a capsule and single intravenous dose in these
patients. IV. Determine any preliminary evidence of antitumor activity of BMS-214662 in
these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-214662 IV over 1 hour on day
-7, followed by oral BMS-214662 daily on days 0-14 for course 1 only. Beginning with course
2, patients receive oral BMS-214662 twice daily for 14 days. Treatment continues every 3
weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose at which fewer than 2 of 6 patients experience
dose limiting toxicity. Patients are followed every 4 weeks until toxicities resolve.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 12-18
months.
Interventional
Primary Purpose: Treatment
David R. Spriggs, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000067537
NCT00004877
July 1999
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |