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Pancreatic
General Information
Study Name:
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 Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Age Group:
Adult
Protocol Number:
NCT02715804
Background Information:
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.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
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.
Participants must be determined to be hyaluronan-high based on tumor biopsy that meets the requirements noted in the previous inclusion criterion.
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.
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.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Additional eligibility in protocol
Ineligibility Information
Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period.
Previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
Known central nervous system involvement or brain metastases.
New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
History of cerebrovascular accident or transient ischemic attack.
Clinically significant pre-existing carotid artery disease.
Additional ineligibility in protocol
Contact Information
Contact Name:
Lindsey Tishman, MHA, CCRC
Contact Phone:
571-472-0633
Contact Email:
lindsey.tishman@inova.org
Additional Information can be found at
https://clinicaltrials.gov/ct2/show/study/NCT02715804