This is a Phase I, open-label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of renal function. Patients will be stratified by baseline 24-hour creatinine clearance(CrCL) into 4 cohorts using the normal clearance formula: Group A: Control Group B:Mild renal dysfunction Group C:Moderate renal function and Group D: Severe renal dysfunction. Six patients will be enrolled into each cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
S-1 administration will be determined by degree of renal impairment as follows: Group A (Control): 30 mg/m2 BID Group B (Mild renal dysfunction): 30 mg/m2 BID Group C (Moderate renal dysfunction): 20 mg/m2 BID Group D (Severe renal dysfunction): 20 mg/m2 QD Pharmacokinetic Phase (Part 1): On Days -2 and 14 of the Pharmacokinetic Phase, patients will receive a single dose of S-1 administered orally in the morning. Treatment will be followed by 1 week of recovery (Days 15 through 21). Extension Phase (Part 2): S-1 will be administered orally for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks.
Premiere Oncology of Arizona
Scottsdale, Arizona, United States
LAC/USC Medical Center
Los Angeles, California, United States
Premiere Oncology
Santa Monica, California, United States
To provide specific dosing recommendations for S-1 in patients with renal impairment based on the PK of S-1 and its components after single dose and steady state conditions.
Time frame: The Pharmacokinetic Phase (Part 1) of the study will last 24 days.
Assess Anti-tumor activity, and safety profile of S-1 in patients with impaired renal function
Time frame: Each cycle of the Extension Phase (Part 2) will be 21 days (14 days of S-1 treatment, 7 days recovery). The end of study for the Extension Phase will be 30 days after the last dose of S-1.
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Yale Cancer Center
New Haven, Connecticut, United States
University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation
Lexington, Kentucky, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cancer Research & Treatment Center/University of New Mexico
Albuquerque, New Mexico, United States
The Institute for Drug Development
San Antonio, Texas, United States