Status:
COMPLETED
Evaluating Patients With Impaired Hepatic Function
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Impaired Hepatic Function
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 hepatic function defined by the NCI classifi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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:
- 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.
- Has a calculated creatinine clearance \> 60 mL/min (by Cockcroft-Gault
- 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:
- 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.
- Required shunting or stenting of the liver within prior 28 days or planned during the first study treatment cycle.
- 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, see Appendix F, 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.
- Previous organ allograft, including liver transplantation.
- Known brain metastasis.
- Known leptomeningeal metastases.
- Manifest ascites.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- 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:
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- Sorivudine, uracil, dipyridamole, cimetidine and folinic acid (may enhance S-1 activity).
- Allopurinol (may diminish S-1 activity).
- Phenytoin (S-1 may enhance phenytoin activity).
- Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 and flucytosine activity).
- 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).
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00398424
Start Date
February 1 2006
End Date
March 1 2009
Last Update
September 3 2024
Active Locations (6)
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1
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
2
Yale Cancer Center
New Haven, Connecticut, United States, 06520
3
University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation
Lexington, Kentucky, United States, 40536
4
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201