What is the HALO Pancreatic 301 study?
HALO Pancreatic 301 is a global Phase 3 clinical research study for patients with untreated Stage IV pancreatic cancer and whose cancer has a high level of a sugar called HA. The study is testing the effects of an investigational drug, called PEGPH20, when given with an approved first-line chemotherapy regimen for Stage IV pancreatic cancer (Abraxane® and gemcitabine).
What treatment will patients receive in this study?
All patients who enroll in HALO Pancreatic 301 will receive the current FDA-approved standard of care for untreated Stage IV pancreatic cancer, a chemotherapy regimen of Abraxane and gemcitabine. (Standard of care means the treatment is recommended by experts.) In addition, 2 out of every 3 patients will also receive the investigational drug PEGPH20. PEGPH20 is a drug being tested in clinical studies and has not been approved by the FDA. It is not known if PEGPH20 works or if it is safe. Patients who do not receive PEGPH20 will be given a placebo in its place. The placebo is normal saline, which is a mixture of salt and water with an amount of salt similar to what is found in body fluids. PEGPH20 or placebo is given in addition to the standard of care chemotherapy that is given to all patients in this study.
How can patients find out if they have HA-HIGH cancer?
Patients can only find out their tumor’s HA status during the screening process for HALO Pancreatic 301. If you have untreated Stage IV pancreatic cancer, contact a HALO Pancreatic 301 study doctor to find out what is required to qualify for the study and how to find out the HA status of your tumor.
Has the investigational drug ever been given to patients?
Yes. HALO Pancreatic 301 is a Phase 3 study. This means the investigational drug, PEGPH20, has already been given to patients in previous studies. So far, over 200 patients with different cancers have received PEGPH20. Each HALO Pancreatic 301 site is experienced in clinical studies. They are knowledgeable about the study treatments and know how to manage potential side effects of these treatments.
How is the investigational drug believed to work?
The investigational drug PEGPH20 is a special type of protein called an enzyme that breaks down HA. Halozyme®, the company who is studying PEGPH20, believes it may enhance the ability of immune cells and certain anti-cancer therapies to reach cancer cells of HA-HIGH tumors by breaking down the HA barrier that builds up in these tumors.
How is PEGPH20 given?
All of the HALO Pancreatic 301 treatments, including PEGPH20, are given through a vein (intravenously, by IV). PEGPH20 typically takes about 10-12 minutes to receive and is given before the chemotherapy regimen.