Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma

Summary

This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.

Timeline

Start

2015-04-20

Primary completion

2017-05

Completion

2017-09

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo/Placebo Arm vs Demcizumab/Placebo and Demcizumab/Demcizumab; p =0.7158; Hazard Ratio (HR) .930 (95% CI 0.630 to 1.375) NCT02289898 ↗

Drugs

Indications