A Phase 1b/2 Multicenter, International, Randomized, Double Blind, placebo-controlled Study of Gemcitabine Combined with PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Compared to Gemcitabine Combined with Placebo in Patients with Stage IV Previously Untreated Pancreatic Cancer
ID Number 12-0367Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
There are two phases to this study:
- The purpose of the first phase is to evaluate the safety and find the best dose of an experimental drug called PEGPH20 when it is combined with another drug called gemcitabine.
- The purpose of the second phase is to determine how well the dose of PEGPH20 found in the first phase works with gemcitabine, to see if PEGPH20 plus gemcitabine works better than gemcitabine alone.
PEGPH20 is being evaluated to see if it decreases tumor growth. PEGPH20 is experimental because the United States Food and Drug Administration has not approved its use except in research studies. The combination of PEGPH20 with gemcitabine is also experimental.
Gemcitabine is an FDA-approved treatment for advanced pancreatic cancer. It is administered intravenously, directly into a vein.
Recruiting Patients: Yes