Boehringer Ingelheim has kicked off a Phase III study of its oral triple angiokinase inhibitor nintedanib in patients with advanced colorectal cancer.
LUME-COLON 1 will look at the safety and efficacy of the drug plus best supportive care (BSC) compared to placebo/BSC in patients who have failed to respond to previous treatment with standard chemotherapy and biological agents.
The trial, which is double-blind, randomised and placebo-controlled in design, plans to include more than 750 patients with CRC at 150 sites sites around the globe. Co-primary endpoints are progression-free survival and overall survival, while secondary ones are objective tumour response rate and disease control rate.
With 1.4 million new cases every year colorectal cancer is the third most common cancer in the world. Prognosis for patients with advanced forms of the disease are poor, with less than 10% surviving for more than five years past diagnosis, highlighting the significant unmet need in the area.
Nintedanib has just been approved in the US for treating the lung scarring disease idiopathic pulmonary fibrosis, and European regulators are currently undertaking a speedy review of drug in the same indication. It is also looking like clearance for non-small cell lung cancer in Europe is imminent, after recently winning backing from the Committee for Medicinal Products for Human Use.