TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Prior treatment

• Has had treatment with any of the following within the specified time frame prior to study drug administration:
  • Major surgery within prior 4 weeks.
  • Any systemic therapy within prior 2 weeks.
  • Any radiation within prior 2 weeks.
  • Any investigational agent received within prior 4 weeks.
• Has received TAS-102.
• 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).

Other illness

• Has disease that is suitable for local therapy administrated with curative intent
• Has a serious illness or medical condition(s) including, but not limited to the following:
  • Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
  • Known brain metastasis or leptomeningeal metastasis.
  • Active infection (i.e. body temperature ≥38°C due to infection).
  • Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
  • Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder.
  • Uncontrolled diabetes.
  • Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
  • Gastrointestinal hemorrhage.
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
  • Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
  • Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
• Untreated active hepatitis B or hepatitis C infections.

Other

• Is a pregnant or lactating female.
• Is inappropriate for entry into this study in the judgment of the Investigator.

• Histological or cytological confirmed advanced or metastatic pancreatic cancer
• Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease
• Documented progression after one or more lines of systemic chemotherapy
  • For the treatment of advanced or metastatic disease
  • Within 6 months after completion of neo-adjuvant therapy or adjuvant therapy
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance 0-1
• Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available
• Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
• Females of childbearing potential must have negative serum or urine pregnancy test
• Have life expectancy ≥ 3 months
• Adequate organ function as defined as:
  • Hemoglobin value of ≥9.0 g/dL.
  • Absolute neutrophil count of ≥1,500/mm3 (IU: ≥1.5 × 10\^9/L).
  • Platelet count ≥100,000/mm3 (IU: ≥100 × 10\^9/L).
  • Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome).
  • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤5 × ULN.
  • Serum creatinine of ≤1.5 mg/dL