A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenoca

Phase:
III

A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenoca

The purpose of this study is to compare the efficacy and safety of PEGPH20 combined with nab-paclitaxel & gemcitabine in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma.

This study is for adult patients with stage IV pancreatic cancer. The purpose of the study is to compare the efficacy (how well the drug works) and safety (how well the drug is tolerated) of the study drug, PEGPH20 compared with Placebo (normal saline, that is, a mixture of salt and water with an amount of salt similar to body fluids) in combination with two chemotherapy drugs nab-paclitaxel (NAB) and gemcitabine (GEM). The study will answer whether the experimental treatment (PEGPH20 with NAB and GEM) is as good as or better than Placebo with NAB and GEM.

Are you Eligible? (Inclusion Criteria)

First line treatment in patients with metastatic pancreatic cancer

Specialty Area(s)

Pancreas

Trial Location

Columbia University Medical Center
Herbert Irving Pavilion
161 Fort Washington Avenue, 8th Floor
New York, NY 10032
United States