Trial Information

Summary: A Study Evaluating the Pharmacokinetics of S-1 in patients with impaired renal function

The purpose of this study is to determine dosing recommendations for S-1 in patients with compromised kidney function. This will be determined through pharmacokinetics. Pharmacokinetics (PKs) is a way to determine the levels of S-1 in the blood and to study how the body processes the drug by looking at how the body absorbs, distributes, metabolizes, and eliminates the drug. In this study, patients will be stratified (assigned to dosing levels) based on creatinine clearance. Only the severely impaired cohort remains open which includes patients whose creatinine clearance is < 30mL/minute. Patients requiring hemodialysis will be excluded from the study.

S-1 is an oral fluoropyrimidine-derived agent developed to enhance the clinical advantage of an oral fluoropyrimidine and control the disadvantage of gastrointestinal side effects that have been experienced with similar drugs. S-1 is not approved by the FDA and is an investigational drug.

Patient Inclusion Criteria:

• Adequate liver and bone marrow function
• Must be able to fast for 10 hours on certain PK days

Not all eligibility criteria are listed. Additional criteria must be met in order to be eligible.

Patient Exclusion Criteria:

• History of sensitivity to 5-FU
• Currently taking uracil, dipyridamole, allopurinol, flucytosine, or pilocarpine

If you would like to learn more about participating in this study, please send an e-mail message using the form below.