TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Exclusion Criteria

• •1. Has disease that is suitable for local therapy administrated with curative intent
• •2. Has a serious illness or medical condition(s) including, but not limited to the following:
• •1. Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
• •2. Known brain metastasis or leptomeningeal metastasis.
• •3. Active infection (i.e. body temperature ≥38°C due to infection).
• •4. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
• •5. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder.
• •6. Uncontrolled diabetes.
• •7. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
• •8. Gastrointestinal hemorrhage.
• •9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
• •10. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
• •11. Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
• •3. Has had treatment with any of the following within the specified time frame prior to study drug administration:
• •1. Major surgery within prior 4 weeks.
• •2. Any systemic therapy within prior 2 weeks.
• •3. Any radiation within prior 2 weeks.
• •4. Any investigational agent received within prior 4 weeks.
• •4. Untreated active hepatitis B or hepatitis C infections.
• •5. Has received TAS-102.
• •6. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation and platinum-induced neurotoxicity).
• •7. Is a pregnant or lactating female.
• •8. Is inappropriate for entry into this study in the judgment of the Investigator.