NCT00398307

Evaluating Patients With Varying Degrees of Renal Function

A Phase I, Open-Label Study Evaluating the Pharmacokinetics of Components of S-1 in Patients With Varying Degrees of Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	S-1/Cisplatin	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.

Timeline

• Start date: 2006-02-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2006-11-10
• Last updated: 2024-09-05

Locations

9 sites across 1 country: United States