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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
Overall Recruitment Status: Active, currently enrolling
 
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
 
Region Sponsors
Colorado
Halozyme Therapeutics
 
Acronym KP IRB No.
1224247
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Stage IV Pancreatic Ductal Adenocarcinoma
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
  • 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 per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, excluding the primary pancreatic lesion.
  • 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
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
 
Exclusion Criteria
  • 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. a. Palliative radiotherapy for pain control of metastatic bone lesions is allowed.
  • 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.
  • Pre-existing carotid artery disease.

 
Keywords and/or Specific Medical Conditions
  • Pancreatic ductal adenocarcinoma (PDA)
  • Pancreatic ductal carcinoma
  • Gemcitabine
  • PEGylated Recombinant Human Hyaluronidase (PEGPH20)
  • Metastatic
  • Stage IV
  • Nab-paclitaxel
  • Oncology (Adult)
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Scott Kono, MS
Contact Information:
- Mai Khang
-720-443-0657
-Mai.X.Khang@kp.org
-Franklin Medical Offices - Denver


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