The POLAR Phase III-study
The Phase III program for PledOx® consists of two double-blinded, randomized, placebo-controlled trials – POLAR-M and POLAR-A.
POLAR-M comprises 420 patients with metastatic colorectal cancer undergoing chemotherapy with FOLFOX (containing oxaliplatin) and will be conducted in Asia, Europe and the US. The trial will compare PledOx® at doses of 2 µmol/kg and 5 µmol/kg, respectively, with a placebo.
POLAR-A comprises 280 patients with colorectal cancer undergoing adjuvant chemotherapy with FOLFOX (containing oxaliplatin) and will be conducted in Asia and Europe. The trial will compare PledOx® at a dose of 5 µmol/kg with a placebo.
The first patient was enrolled in November 2018.