A Phase I and Pharmacokinetic Study of SR-45023A During a 14-Day Treatment Schedule
OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally
advanced or metastatic solid tumors that are refractory or for which no standard therapy
exists. II. Determine the quantitative toxic effects of SR-45023A in these patients. III.
Assess the pharmacokinetic profile of SR-45023A in these patients. IV. Identify the
antitumor activity of SR-45023A in these patients.
OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A twice daily for 14
days, followed by 7 days rest. On day 14 of course 1, patients receive only one dose of
therapy due to pharmacokinetic sampling. Treatment continues every 21 days 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 reached. The MTD is defined as
the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients
are followed until death.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.
Primary Purpose: Treatment
United States: Federal Government
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