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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

NCT02715804 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2020-07-14

Study results available
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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).

Conditions

  • Pancreatic Ductal Carcinoma

Interventions

OTHER

Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)

PEGPH20 will be administered as per the dose and schedule specified in the respective arms.

DRUG

Placebo

Matching placebo for PEGPH20

DRUG

nab-Paclitaxel

Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.

DRUG

Gemcitabine

Gemcitabine will be administered as per the dose and schedule specified in the respective arms.

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • VP, Medical, Regulatory and Drug Safety · Halozyme Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-14
Primary Completion
2019-11-04
Completion
2019-11-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02715804 on ClinicalTrials.gov