Effect Of Ketoconazole On The Pharmacokinetics Of BMS-247550 In Patients With Advanced Cancer
- Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients
with advanced solid tumors.
- Determine the safety of ixabepilone when administered alone and in combination with
ketoconazole in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of ixabepilone.
During course 1, patients receive oral ketoconazole on days 0-5 and ixabepilone IV over 3
hours on day 1. During course 2 and subsequent courses, patients receive only ixabepilone IV
over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or
Cohorts of at least 3 patients receive escalating doses of ixabepilone during course 1 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 patients experience dose-limiting toxicity. At least 12 patients are
treated at the MTD.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Effect of ketoconazole on the pharmacokinetics of ixabepilone
Sridhar Mani, MD
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|