Phase I Evaluation of KRN5500 (NSC650426)
OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of KRN5500 in patients
with solid malignant tumors. II. Characterize the clinical pharmacokinetics of KRN5500 in
this patient population. III. Initiate the preliminary evaluation of antitumor activity of
KRN5500 in these patients. IV. Determine the recommended Phase II dose of KRN5500.
OUTLINE: This is a dose escalation study. Patients receive KRN5500 IV over 1 hour on days
1-3. Courses repeat every 21 days. Patients with stable disease and partial or complete
remission continue treatment for 6 months beyond complete remission. Cohorts of 3 to 6
patients receive escalating doses of KRN5500. The maximum tolerated dose is defined as the
dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study over 9-12
Primary Purpose: Treatment
Patricia M. LoRusso, DO
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|