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

Disease (cancer type)

Pancreatic Cancer

Contact information

  • North Florida / Jacksonville: Rhonda Calhoun (904) 427-1217

Patient Selection Criteria

Ages Eligible for Study: 18 Years and older (Adult, Senior) Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria 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 per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion. 5.If a participant has had adjuvant therapy (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 adjuvant therapy, provided all toxicities have returned to baseline or ≤ Grade 1. 6.Eastern Cooperative Oncology Group Performance Status of 0 or 1.

Research sponsor

Halozyme Therapeutics

Reference ID#

Halozyme HALO

State(s)

  • Florida

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