A phase 2 randomized multicenter study of PEGPH20 (hyaluronidase) combined with nab-paclitaxel plus gemcitabine compared with nab-paclitaxel plus gemcitabine in subjects with stage IV previously untreated pancreatic cancer
ID Number 13-1302Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
This study is testing an experimental drug called PEGPH20. Experimental means the United States Food and Drug Administration has not approved PEGPH20 for use except in research studies like this.
There are two parts to this study. The purpose of both parts is to evaluate PEGPH20 at a dose of 3 micrograms per kilograms (μg/kg, based on body weight) in combination with 2 chemotherapy drugs. These drugs are a standard dose of gemcitabine plus a dose of nab paclitaxel that has been tested in pancreatic cancer patients. This combination will be compared to gemcitabine and nab-paclitaxel alone (without PEGPH20). The first part of this study (run-in phase) will study the safety and tolerability of these combinations. The second part (phase 2) will study the safety and efficacy (how well the drug works) of these combinations.
Recruiting Patients: Yes