CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

Inclusion Criteria

• •Patients with histologically confirmed metastatic pancreatic ductal carcinoma
• •One or more metastatic lesions measurable on MRI, PET/CT, or dedicated CT scan according to RECIST v1.1.
• •Eligible for treatment with nabpaclitaxel and gemcitabine
• •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• •Life expectancy of at least 3 months
• •Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts
• •The patient is capable of understanding and complying with the protocol and the subject or, when applicable, the subject's legally acceptable representative has signed the informed consent
• •A negative serum pregnancy test (if a premenopausal female patient)
• •Acceptable liver function: Bilirubin ≥ 1.5 times upper limit of normal; AST (SGOT) \< 10 times upper limit of normal, ALT (SGPT) and Alkaline phosphatase 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed).
• •Acceptable renal function: Serum creatinine within normal limits; calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal by the Cockroft-Gault equation.
• •Acceptable hematologic status: Granulocyte ≥ 1500 cells/mm3; Platelet count ≥ 100,000 plt/mm3; Hemoglobin ≥ 9 g/dL.
• •Urinalysis: No clinically significant abnormalities.
• •Acceptable coagulation status: PT within normal limits; PTT within normal limits.
• •For men and women of child-producing potential, the use of effective contraceptive methods during the study.