Sitagliptin Combined With Gemcitabine and Albumin-bound Paclitaxel in PDAC Patients
PDAC - Pancreatic Ductal Adenocarcinoma

About this trial
This is an interventional treatment trial for PDAC - Pancreatic Ductal Adenocarcinoma focused on measuring PDAC, sitagliptin
Eligibility Criteria
Inclusion Criteria: 1.≥ 18 years old at the time of informed consent 2.Ability to provide written informed consent and HIPAA authorization 3.Untreated locally advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) as defined by National Comprehensive Cancer Network (NCCN) guidelines or, untreated metastatic PDAC (prior adjuvant therapy is permitted if it's been greater than 6 months since completion) 4.Histologically or cytologically confirmed PDAC 5.Confirmed PDAC that is measurable or evaluable per RECIST 1.1 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7.Gastrointestinal symptoms (nausea, vomiting, and diarrhea) of Grade 1 or less 8.Adequate organ function as defined by: Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 3 x upper limits of normal (ULN) Total bilirubin level ≤ 2 x ULN Creatinine level < 1.7mg/dL For patients with a Body Mass Index (BMI) > 30 kg/m2, lean body weight should be used to calculate the glomerular filtration rate (GFR). Hemoglobin (Hgb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 80 x 109/L, Acceptable coagulation studies as demonstrated by prothrombin time (PT) within normal limits (+/-15%) unless they are on anticoagulation therapy Life expectancy estimated at ≥ 3 months Exclusion Criteria: With any cancer other than PDAC in recent 5 years; With myocardial infarction; Uncontrolled hypertension (systolic pressure>150mmHg or diastolic pressure>100mmHg after treatment) LVEF<50% History of hemorrhage or thromboembolism in the last 6 months Psychiatric history Pregnant or breastfeeding Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung Autoimmune disease Uncontrolled active infection Other drugs that must be used during the trial may affect the metabolism of the experimental drugs (Sitagliptin, gemcitabine, nab-paclitaxel)
Sites / Locations
Arms of the Study
Arm 1
Experimental
Experimental: Combination of sitagliptin+ gemcitabine + nab-paclitaxel
Drug: Sitagliptin Sitagliptin will be administered orally once a day at a dose of 100 mg depending on cohort assignment. Drug: Gemcitabine Gemcitabine will be intravenously administered on Days 1 and 8 of every 21-day cycle at a dose of 1000 mg/m2 depending on cohort assignment. Drug: Nab-Paclitaxel Nab-Paclitaxel will be intravenously administered on Days 1 and 8 of every 28-day cycle at a dose of 125 mg/m2 depending on cohort assignment.