A Study of PEGylated Recombinant Human Hyaluronidase 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

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicentre 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

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).

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Progression Free Survival (PFS)
  • Objective Response Rate (ORR)
  • Duration of Response (DOR)
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Considered Related to Study Drug by Investigator
Participants will be randomized in a 2:1 ratio to PAG or AG treatment. If the final analysis supports a positive benefit-risk assessment for PEGPH20, participants in the PAG arm post-final analysis will be offered the option to continue PAG treatment if the Investigator deems it in their best interest. Participants in the AG arm post-final analysis will be offered the option to switch to and continue on PAG treatment. Participants in the AG arm post-final analysis who choose not to switch to PAG treatment will be discontinued from the study. These participants will be treated according to the Investigator's discretion and local standard-of-care. Participants continuing PAG treatment and participants switched from AG to PAG treatment post-final analysis will enter long-term follow-up after treatment discontinuation. All participants who have discontinued either PAG or AG treatment and are in long-term follow-up will continue to be followed up until the participant dies, is lost to follow-up, or withdraws consent.

View this trial on ClinicalTrials.gov

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Resources

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