A Phase I Study of Oral ILX23-7553 in Patients With Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of
ILX23-7553 in patients with refractory solid tumors. II. Determine the principal and dose
limiting toxicities of this treatment regimen in terms of duration and reversibility in this
patient population. III. Determine the preliminary evidence of antitumor activity with this
treatment regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients receive oral ILX23-7553 for
5 days. Treatment repeats every 2 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ILX23-7553 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 6 or 2 of 10 patients experience dose limiting toxicity. Patients are
followed monthly for at least 2 months.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study within 12-18
months.
Interventional
Primary Purpose: Treatment
Steven Soignet, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
MSKCC-99078
NCT00004926
October 1999
December 2009
Name | Location |
---|---|
New Jersey Medical School | Newark, New Jersey 07103-2714 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |