To compare the treatment effect of PEGPH20 combined with nab-Paclitaxel and Gemcitabine to nab-Paclitaxel and Gemcitabine in subjects with Stage IV pancreatic cancer.
Give Informed consent.
Have histologically confirmed Stage IV pancreatic ductal adenocarcinoma with documented disseminated neoplasm to liver and/or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
Have one or more measurable metastatic tumors measurable on CT scan per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 ).
Have no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
Have a Karnofsky Performance Status >= 70%.
Have a life expectancy >= 3 months.
Be age >= 18 years.
Have screening labs of bilirubin, aspartate transaminase(AST), alanine transaminase(ALT), serum creatinine and albumin, absolute neutrophil count (ANC), hemoglobin, hematocrit and partial thromboplastin time(PTT) within specified values/criteria per protocol prior to dosing.
Have Non-metastatic pancreatic ductal adenocarcinoma.
Have known central nervous system involvement or brain metastasis.
Have New York(NY) Heart Assoc Class III or IV cardiac disease or myocardial infarction within the past 12 months.
Have active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
Have known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C.
Have a 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.
Have 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.
The inclusion and exclusion criterias listed here are not all inclusive.