A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer

Inclusion criteria

• Patients aged 20 - 80 years old at the time of signing the ICF.
• Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant gemcitabine are acceptable, unless exclusion criteria met).
• Eastern Cooperative Oncology Group (ECOG) performance status of 1 to 2.
• Adequate hematologic function defined as: absolute neutrophil count (ANC) >= 2,000/μL; platelets count >= 100,000/μL; hemoglobin must be >= 10 g/dL (can be corrected by growth factor or transfusion).
• Adequate hepatic function defined as: serum bilirubin =< 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 3-fold ULN (5-fold ULN if liver metastasis is observed).
• Adequate renal function with: serum creatinine =< 1.3 mg/dL or calculated creatinine clearance >= 60 mL/minute according to the Cockcroft and Gault formula.
• At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months.
• Planning to receive Gemcitabine monotherapy.
• Willing and able to comply with all aspects of the treatment protocol.
• Provide written informed consent.

Exclusion criteria

• Patients with following treatment prior to Gemcitabine monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 28 days of study entry.
• Pancreatic patients with prior history of Gemcitabine chemotherapy.
• Women who are pregnant or breastfeeding.
• Patients with brain metastasis.
• Patients with bone metastasis alone.
• Patients with autoimmune disease that requires systemic steroids or immunosuppression agents.
• Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
• Known history of human immunodeficiency virus (HIV) infection.
• Existing anticancer treatment-related toxicities of Grades >= 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).
• Patients with an active infection requiring systemic therapy.
• Patients are hepatitis C virus (HCV) carrier, and/or with active viral disease which is defined as hepatitis B virus (HBV) carrier with HBV DNA > 2,000 IU/ml plus AST and ALT > 3-fold ULN.
• History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the patient's ability to safely complete the study.
• Ascertained hypersensitivity to investigational product, Gemcitabine or any of the excipients used in the study.
• Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily BLEX 404 Oral Liquid treatment.
• Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.