Clinical Trials

Key Inclusion Criteria:

• Signed Informed consent
• Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
• One or more measurable metastatic tumors measurable on CT san per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 ).
• No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
• BMI < 35kg/m2
• Karnofsky Performance Status ≥ 70%
• Life expectancy ≥ 3 mos
• Age ≥ 18 years
• Screen labs of Hemoglobin,white blood cells, platelets, absolute neutrophil count (ANC), bilirubin, AST, ALT, serum creatinine, serum albumin, PT/INR, and PTT within specified values/criteria per protocol prior to dosing.

Key Exclusion Criteria:

• Non metastatic pancreatic ductal adenocarcinoma
• Evidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) during screening period.
• Known Central nervous system involvement, brain metastasis
• New York(NY) Heart Assoc Class III or IV cardiac disease or Myocardial infarction within the past 12 months.
• Prior history of cerebrovascular accident or transient ischemic attack
• Pre-existing carotid artery disease
• Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
• Current use of megestrol acetate (Use within 10 days of Day 1)
• Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C
• History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer or curatively-treated cervical cancer in-situ.
• Contraindication to heparin as per NCCN guidelines
• Previous bleed on LMWH
• Any other disease, metabolic dysfunction, physical examination finding or clinical lab finding that leads to reasonable suspicion of disease or condition that contraindicates the use of an investigational drug, that may affect interpretation of results, or render the subject at a high risk of treatment complications.