A Phase I Clinical and Pharmacokinetic Evaluation of LY293111 in Patients With Solid Tumors (Protocol H6H-MC-JEAI)
OBJECTIVES: I. Determine the maximum tolerated dose of LY293111 in patients with advanced
solid tumors. II. Determine the safety profile and pharmacokinetics of this regimen in these
patients. III. Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral LY293111 twice daily.
Treatment continues for a maximum of 6 months in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LY293111 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 or 6 patients experience dose limiting toxicity. Additional patients
are treated at the MTD. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
Primary Purpose: Treatment
Gary K. Schwartz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|North Shore University Hospital||Manhasset, New York 11030|