Halozyme Therapeutics has reported the commencement of patient dosing in a phase II clinical trial with pegylated rHuPH20 (PEGPH20) in patients with stage IV previously untreated pancreatic cancer. This multi-center, international, randomized, placebo-controlled trial will study the safety, tolerability and efficacy of gemcitabine plus PEGPH20 compared to gemcitabine plus placebo.
The trial, which includes a single arm run-in stage, will evaluate gemcitabine plus PEGPH20 compared to gemcitabine plus placebo in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. In the phase II portion, patients will be randomized to receive either PEGPH20 plus gemcitabine or placebo plus gemcitabine, respectively. Over 140 patients are expected to be enrolled globally. The primary endpoint of the phase II portion of the trial is overall survival (OS). The trial will also evaluate secondary endpoints such as CA19-9, objective response rate and duration of response. CA19-9 is a tumor marker tested from blood samples in patients with pancreatic cancer.