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Complete title: A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined with nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine in Subjects with Stage IV Previously Untreated Pancreatic Cancer( WIRB HALO-109-202)
|Research Study Number||2687.00|
|Principal Investigator||Sunil Hingorani, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
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.
- 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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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.
Other exclusion criteria may apply.
Gastrointestinal Cancer; Pancreatic Cancer; Solid Tumors
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