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
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To determine the safe dose of PEGPH20 in combination with the approved dose of gemcitabine.
The safety and tolerability profile of PEGPH20 used in combination with gemcitabine will be assessed.
Joy H Zhu, MD, PhD
United States: Food and Drug Administration
|Mount Sinai School of Medicine||New York, New York 10029|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|
|Highlands Oncology Group||Springdale, Arkansas 72764|
|SUNY Upstate Medical University||Syracuse, New York 13210|
|California Pacific Medical Center||San Francisco, California 94115|
|UMDNJ - New Jersey Medical School||Newark, New Jersey 07103|
|NSLIJ Health System, Monter Cancer Center||New Hyde Park, New York 11040|