Evaluating Patients With Varying Degrees of Renal Function

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT00398307

Run by

Taiho Oncology, Inc.

People needed

24

Starts

2006-02-01

Expected to finish

2010-09-01

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
• Has histologically or cytologically proven advanced solid tumors for which no standard therapy exists.
• Has provided written informed consent.
• Is 18 years of age or older.
• Is able to take medications orally.
• Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to ≤ 2 Appendix A,ECOG Performance Status).
• Has adequate organ function as defined by the following criteria:
• Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal(ULN). If liver function abnormalities are due to underlying malignancy, then AST(SGOT) and ALT (SGPT) may be ≤ 5 times ULN.
• Total serum bilirubin ≤ 1.5 times ULN.
• Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units [IU]).
• Has a platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L).
• Has a hemoglobin value of ≥ 9.0 g/dL.
• Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• 3.2 Exclusion Criteria
• Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed:
• Has had treatment with any of the following within the specified time frame prior to study drug administration:
• Any investigational agent received either concurrently or within the last 30 days.
• Previous therapy for malignancy within 21 days, including any chemotherapy, immunotherapy, biologic or hormonal therapy (6 weeks for nitrosoureas or mitomycin(C).
• Previous radiotherapy within 14 days.
• Current enrollment in another clinical trial.
• Has a serious illness or medical condition(s) including, but not limited to, the following:
• Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure (New York Heart Association [NYHA] Class III or IV, Appendix E, NYHA Classification).
• Known (at the time of entry) gastrointestinal disorder, including malabsorption, chronic nausea, vomiting, or diarrhea present to the extent that it might interfere with oral intake and absorption of the study medication.
• Known brain metastasis.
• Known leptomeningeal metastases.

Where it is running

• Premiere Oncology of Arizona — Scottsdale, Arizona, United States
• LAC/USC Medical Center — Los Angeles, California, United States
• Premiere Oncology — Santa Monica, California, United States
• 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

Full record on ClinicalTrials.gov

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