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Summary

Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

Official 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

Keywords

Stage IV Pancreatic Ductal Adenocarcinoma Pancreatic ductal adenocarcinoma (PDA) Pancreatic ductal carcinoma PEGylated Recombinant Human Hyaluronidase (PEGPH20) Nab-paclitaxel Gemcitabine Metastatic Stage IV Paclitaxel Albumin-Bound Paclitaxel Hyaluronic Acid

Eligibility

For people ages 18 years and up

  1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
  2. Stage IV pancreatic ductal adenocarcinoma (PDA) with histological confirmation of PDA via archived or fresh core biopsy of either the primary tumor or 1 metastatic site.
  3. Participants must be determined to be hyaluronan-high based on tumor biopsy that meets the requirements noted in the previous inclusion criterion.
  4. At least 1 tumor metastasis measurable on computed tomography (CT) scan and/or magnetic resonance imaging (MRI) per the Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
  5. If a participant has had adjuvant/neoadjuvant therapy and/or therapy for locally advanced disease (chemotherapy for non-metastatic pancreatic cancer in combination with or without radiation therapy), tumor recurrence or disease progression must have occurred no sooner than 6 months after completing the last dose of the aforementioned therapies, provided all toxicities have returned to baseline or ≤ Grade 1.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion criteria:

  1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.
  2. Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

    a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.

  3. Known central nervous system involvement or brain metastases.
  4. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
  5. History of cerebrovascular accident or transient ischemic attack.
  6. Clinically significant pre-existing carotid artery disease.

Locations

  • Pacific Hematology Oncology Associates accepting new patients
    San Francisco, California, United States
  • St Joseph Heritage Healthcare accepting new patients
    Santa Rosa, California, United States
  • David Geffen School of Medicine (DGSOM) at UCLA accepting new patients
    Los Angeles, California, United States
  • Samuel Oschin Comprehensive Cancer Institute accepting new patients
    Los Angeles, California, United States
  • Innovative Clinical Research Institution accepting new patients
    Whittier, California, United States
  • Long Beach Memorial Medical Center accepting new patients
    Long Beach, California, United States
  • St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health accepting new patients
    Fullerton, California, United States
  • Chao Family Comprehensive Cancer Center accepting new patients
    Orange, California, United States
  • St. Joseph Hospital accepting new patients
    Orange, California, United States
  • Comprehensive Cancer Centers of Nevada accepting new patients
    Las Vegas, Nevada, United States
  • Desert Hematology Oncology Medical Group, Inc. accepting new patients
    Rancho Mirage, California, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Halozyme Therapeutics
ID
NCT02715804
Phase
Phase 3
Study Type
Interventional
Last Updated
June 1, 2017
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