Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma

Inclusion Criteria

• •Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF).
• •Histologically confirmed locally advanced unresectable (Stage III) or Stage IV PDAC.
• •Measurable or evaluable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
• •For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted. For patients with metastatic disease, prior treatment for non-metastatic disease with 5-FU or gemictabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ≥ Grade 2 treatment-related toxicities are present.
• •Karnofsky Performance Status ≥70%.
• •Life expectancy ≥3 months.
• •Age ≥18 years.
• •A negative serum pregnancy test, if female of reproductive potential.
• •Screening clinical laboratory values as follows, performed within 14 days prior to day 1:
• •* Total bilirubin ≤1.5 times upper limit of normal (ULN).
• •* Aspartate aminotransferase (\[AST\]; serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (\[ALT\]; serum glutamic pyruvate transaminase \[SGPT\]) ≤2.5 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed).
• •* Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min.
• •* Serum albumin ≥3.0 g/dL.
• •* Absolute neutrophil count (ANC) ≥1,500 cells/mm3.
• •* Platelet count ≥100,000 plt/mm3.
• •* Hemoglobin ≥9 g/dL
• •* Prothrombin time (PT)/international normalized ratio (INR) within normal limits (±15%) or within therapeutic range if on warfarin.
• •* Partial thromboplastin time (PTT) within normal limits (±15%).
• •For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study. Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study.