Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Phase 1b/2 Multicenter, International, Randomized, Double Blind, Placebo-Controlled, Study of Gemcitabine Combined With PEGPH20 Compared to Gemcitabine Combined With Placebo in Patients With Stage IV Previously Untreated Pancreatic Cancer
Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and
tolerability study to determine the safe dose of PEGPH20 to use in combination with
gemcitabine in Stage IV previously untreated pancreatic cancer patients.
Phase 2: Randomized, double blind study to compare the effect of overall survival of
gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated
pancreatic cancer patients.
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.
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