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A Randomised, Double-blinded Phase II Study of Gemcitabine and Nab-Paclitaxel With CEND-1 or Placebo in Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Australasian Gastro-Intestinal Trials Group (AGITG)
Other Non-Commercial Sponsor
University of Sydney
This is a double-blind trial and eligible participants will be randomly allocated to either the Experimental Arm or Placebo Comparator Arm. In the Experimental Arm, participants will receive nab-paclitaxel (125mg/m2 intravenously [IV]); CEND-1 (3.2mg/kg IV), and gemcitabine (1000mg/m2) on Day 1, 8 and 15 of each 21-day cycle. In the Placebo Comparator Arm, participants will receive nab-paclitaxel (125mg/m2); placebo (IV); and then Gemcitabine (1000mg/m2) on Day 1, 8 and 15 of each 21-day cycle.