A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors

Inclusion Criteria

• •1. Has advanced, metastatic or unresectable GI tract tumors that are refractory or intolerant to existing available therapies and for whom the investigator recommends fluoropyrimidine monotherapy.
• •2. Has measurable disease in accordance with Respond Evaluation Criteria in Solid Tumors (RECIST) guidelines (Version 1.1).
• •3. Is aged ≥18 years
• •4. Has not received treatment with intravenous (IV) 5 FU or oral 5 FU analogs in the 4 weeks preceding enrollment
• •5. Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at study entry
• •6. Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:
• •1. peripheral ANC of ≥1.5 × 109/L
• •2. platelet count of ≥75 × 109/L without growth factor/transfusion
• •3. hemoglobin ≥8.5 g/dL without growth factor/transfusion
• •4. estimated glomerular filtration rate \>50 mL/min
• •5. total bilirubin \<2 × upper limit of normal (ULN); \<5 × ULN if patient has liver metastases, biliary tract cancer; or ≤3 × ULN if the patient has Gilbert's disease
• •6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 × ULN, with liver metastasis \<5 × ULN
• •7. international normalized ratio (INR) \<1.5
• •7. Has a life expectancy of at least 12 weeks
• •8. Female patients of childbearing potential and male patients with partners capable of reproduction must agree to use an effective contraceptive method from the time of Screening through 60 days after the last dose of capecitabine
• •9. Females of childbearing potential must have a negative serum β human chorionic gonadotropin pregnancy test result
• •10. Willingly provides written, informed consent.
• •11. Has resolution or stabilization of acute toxicity from prior therapy to Grade \<2 - except Grade 2 neuropathy
• •12. If patient has human immune deficiency virus (HIV) infection, it is controlled with undetectable viral load with antiretroviral treatment.
• •13. If patient has hepatitis C infection and received antiviral treatment, has a negative viral load at Screening
• •14. If patient has chronic hepatitis B infection and is receiving antiviral treatment, has a negative viral load at Screening.
• •15. Is willing and able to comply with all protocol required visits and assessments