RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have locally advanced or metastatic solid tumors that have not responded to previous treatment.
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally advanced or metastatic solid tumors. II. Determine the quantitative and qualitative toxic effects of SR-45023A in these patients. III. Assess the plasma and urine pharmacokinetics of SR-45023A and relate these to drug effects, if possible, in these patients. IV. Determine any preliminary antitumor activity of SR-45023A in these patients. OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A weekly. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SR-45023A until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for up to 1 month. PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
36
Institute for Drug Development
San Antonio, Texas, United States
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