|Title||Halozyme HALO 109-301|
|Principal Investigator/ Physician||William Taylor, MD|
|Protocol No.||HALO 109-301|
|Contact Email||MCI Clinical Trials|
Protocol Title: "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."
Inclusion Criteria: Stage 4 pancreatic ductal adenocarcinoma with histological confirmation via archived or fresh core biopsy/ HA-high based ; 1 measurable lesion, If adjuvant treatment received recurrence must be >6 months after last dose; ECOG 0-1; life expectance > 3 months; adequate lab values
Exclusion Criteria: Evidence of DVT/ PE or other known TE event, no previous treatment for metastatic disease, known CNS mets, NYHA class III or IV cardiac disease, no MI, CVA or TIA in last 12 months, known HIV, Hepatitis B or C; current use of megestrol acetate (10 day wash out) no immunization with live vaccine up to 2 wks prior to day 1. Hypersensitivity to PEGPH20, gemcitabine and nab-paclitaxel.
Clinical Trials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02715804?term=109-301&rank=1
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