PEGPH20 in patients with pancreatic cancer with high levels of HA
Research type
Research Study
Full title
A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Multi-centre Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
IRAS ID
192397
Contact name
Minal Kara
Contact email
Sponsor organisation
Halozyme, Inc.
Eudract number
2015-004068-13
Clinicaltrials.gov Identifier
102770, IND
Duration of Study in the UK
2 years, 11 months, 27 days
Research summary
Pancreatic cancer is a heterogeneous (non-uniform in composition i.e. colour, shape, size etc) disease with malignancies developing from pancreatic ductal, and clusters of cells such as acinar, and islet cells. The incidence of pancreatic cancer has continued to increase during the past several decades, and adenocarcinoma of pancreatic ductal (PDA) (a form of pancreatic cancer) origin accounts for over 80% of all pancreatic cancers and is a leading cause of cancer-related death.
PEGPH20 (the study drug) depletes hyaluronan (HA), a component that accumulates in some tumours. HA accumulation in the tumour microenvironment (small scale environment of an organism) impedes (obstructs) chemotherapy delivery to the tumour, and elevated levels of HA frequently correlate with poor prognosis in tumours such as pancreatic, breast, gastric, colorectal, ovarian, prostate and lung carcinoma. PEGPH20 represents a potential new therapeutic approach to improve chemotherapy delivery. In clinical studies, the combination of PEGPH20 with the standard-of-care chemotherapy drugs nab-paclitaxel (NAB) and gemcitabine (GEM) resulted in clinically meaningful improvements in efficacy in PDA patients.
This randomised, placebo-controlled double- blind (i.e., subjects, Investigator, and Halozyme, the Sponsor, are blinded to the identity of treatment) study is to compare the efficacy and safety of PEGPH20 plus NAB and GEM, compared with placebo plus NAB and GEM treatment in subjects with advanced, previously untreated PDA whose tumours are HA high.
This is a global Phase 3 study which will enrol subjects at clinical sites worldwide. It is anticipated that approximately 420 and up to 570 participants will take part in this study. The study will initiate early in 2016.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0083
Date of REC Opinion
13 Apr 2016
REC opinion
Further Information Favourable Opinion