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A Phase I, Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function

Phase 1
18 Years
Not Enrolling
Impaired Hepatic Function

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Trial Information

A Phase I, Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function

Inclusion Criteria:

A patient must meet all of the following inclusion criteria to be eligible for enrollment
in this study:

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. Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units

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

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

4. Has a calculated creatinine clearance > 60 mL/min (by Cockcroft-Gault

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

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:

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

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.

5. Required shunting or stenting of the liver within prior 28 days or planned
during the first study treatment cycle.

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

1. Myocardial infarction within the last 6 months, severe/unstable angina,
congestive heart failure (New York Heart Association [NYHA] Class III or IV, see
Appendix F, 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. Previous organ allograft, including liver transplantation.

4. Known brain metastasis.

5. Known leptomeningeal metastases.

6. Manifest ascites.

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

8. 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

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
(including male patients).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To provide specific dosing recommendations for S-1 in patients with hepatic impairment based on the PK of S-1 and its components after single dose and during steady state condition

Outcome Time Frame:

The Pharmacokinetic Phase (Part 1) of the study will last 24 days.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

March 2009

Related Keywords:

  • Impaired Hepatic Function
  • Impaired Hepatic Function



Washington University School of Medicine Saint Louis, Missouri  63110
Yale Cancer Center New Haven, Connecticut  06520-8028
The Institute for Drug Development San Antonio, Texas  78229
Premiere Oncology of Arizona Scottsdale, Arizona  85260
University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation Lexington, Kentucky  40536
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland  21201