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  • Halozyme Pancreatic HALO-109-301

    Acronym: 

    HALO-109-301

    ACTRN/NCT /ethics: 

    NCT02715804

    Scientific title: 

    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) 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 Adenocarcinoma

    Summary of trial and patient characteristics

    Cancer Type Pancreas
    Trial Type Treatment
    Phase Phase III Tumour Stream Pancreatic Dutal Adenocarcinoma
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2016-02-01
    Molecular Target Anticipated End Date 2019-12-01
    Cancer Type Pancreas
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Pancreatic Dutal Adenocarcinoma
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2016-02-01
    Anticipated End Date 2019-12-01

    Trial Summary

    The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). Participants will be randomized in a 2:1 ratio to PAG or AG treatment.

    Lay Summary

    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) 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 Adenocarcinoma

    Sponsor / Cooperative group

    Halozyme Therapeutics

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Chris Karapetis Recruiting
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 70742342 Recruiting
    The Queen Elizabeth Hospital Sue Yeend sue.yeend@sa.gov.au 08 8222 6148