|Closed||Pancreatic Cancer||Phase I/II||
PEGPH20 is a PEGylated version of human recombinant PH20 hyaluronidase that, in preclinical studies, has been shown to remove HA from the extracellular matrix surrounding tumor cells by depolymerizing this substrate. 87% of pancreatic ductal adenocarcinomas (PDA) overexpress HA. PDA tumor tissue may be especially sensitive to the HA-degradation properties of PEGPH20 and thus more responsive to the cytotoxic effects of a given dose of gemcitabine. Modifying the extracellular environment to increase the penetration and efficacy of anti-cancer agents represents a novel approach to treating pancreatic cancer and may provide important therapeutic outcomes in patients with Stage IV Previously Untreated Pancreatic Cancer.
This Phase 1B/2 study will assess safety, tolerability, treatment effect, and various PK/PD endpoints.
- One or more metastatic tumors measurable on CT scan per RECIST 1.1 criteria
- Patients with histologically confirmed Stage IV adenocarcinoma of the pancreas previously untreated for metastatic disease
- Baseline CA19-9 of ≥ 100 U/mL in the absence of biliary obstruction or other physiological process unrelated to the tumor that may cause an elevation in CA19-9 levels
- Life expectancy of at least 3 months
- Signed, written IRB/EC-approved informed consent
- A negative serum pregnancy test, if female
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 12 months, or cardiac arrhythmia requiring medical therapy
- Known brain metastasis
- Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- Known allergy to hyaluronidase
- Women currently pregnant or breast feeding
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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