SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I and Pharmacokinetic Study of SR-45023A Administered Once Every 7 Days|
|Study Start Date:||April 1999|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004049
|United States, Texas|
|Institute for Drug Development|
|San Antonio, Texas, United States, 78245-3217|
|Study Chair:||Kathleen Nolte||Genzyme, a Sanofi Company|