|Closed||Metastatic Pancreatic Cancer||Phase II||
To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer. Phase 2 (safety and treatment effect), 124 subjects, 1:1 ratio, PAG:AG, preceded by 8 subject Run-In phase (safety and tolerability).
- 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.
- Karnofsky Performance Status >= 70%
- Life expectancy >= 3 mos
- Age >= 18 years
- Screen 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.
- Non metastatic pancreatic ductal adenocarcinoma
- 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.
- Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
- 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.
- 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.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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