SR-45023A in Treating Patients With Advanced Solid Tumors
Recruitment status was Active, not recruiting
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 advanced solid tumors.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I and Pharmacokinetic Study of SR-45023A During a 14-Day Treatment Schedule|
|Study Start Date:||August 1998|
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.