Evaluating Patients With Varying Degrees of Renal Function

NCT ID: NCT00398307

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-09-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Has histologically or cytologically proven advanced solid tumors for which no standard therapy exists.

2. Has provided written informed consent.

3. Is 18 years of age or older.

4. Is able to take medications orally.

5. Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to ≤ 2 Appendix A,ECOG Performance Status).

6. Has adequate organ function as defined by the following criteria:

1. 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.

2. Total serum bilirubin ≤ 1.5 times ULN.

3. Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units [IU]).

4. Has a platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L).

5. Has a hemoglobin value of ≥ 9.0 g/dL.

7. Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

1. Has had treatment with any of the following within the specified time frame prior to study drug administration:

1. Any investigational agent received either concurrently or within the last 30 days.

2. Previous therapy for malignancy within 21 days, including any chemotherapy, immunotherapy, biologic or hormonal therapy (6 weeks for nitrosoureas or mitomycin(C).

3. Previous radiotherapy within 14 days.

4. Current enrollment in another clinical trial.

2. Has a serious illness or medical condition(s) including, but not limited to, the following:

1. 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).

2. 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.

3. Known brain metastasis.

4. Known leptomeningeal metastases.

5. Requires hemodialysis.

6. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome(AIDS)-related illness.

7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.

3. Is receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1:

1. Sorivudine, uracil, dipyridamole, cimetidine and folinic acid (may enhance S-1 activity).

2. Allopurinol (may diminish S-1 activity).

3. Phenytoin (S-1 may enhance phenytoin activity).

4. Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 and flucytosine activity).

5. Pilocarpine (may inhibit CYP2A6 activity).

4. Has known sensitivity to 5-FU.

5. Is a pregnant or lactating female.

6. Is a patient with reproductive potential who refuses to use an adequate means of contraception

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

TPU-S1111

Identifier Type: -

Identifier Source: org_study_id