Boehringer Ingelheim has announced that it has enrolled the first participant in a global phase 3 trial investigating nintedanib in patients with metastatic colorectal cancer.
The randomized, double-blind, placebo-controlled study known as LUME-COLON 1 will evaluate the efficacy and safety of nintedanib in combination with best supportive care compared with placebo plus best supportive care in patients with metastatic colorectal cancer whose disease has progressed during or after standard chemotherapy and biological agents.
The researchers plan to enroll more than 750 patients with relapsed or refractory metastatic colorectal cancer at 150 sites internationally. Primary endpoints are progression-free survival assessed by a blinded review committee and overall survival. Secondary endpoints include objective tumor response rate and disease control rate.
Nintedanib is a tyrosine kinase inhibitor (TKI) that blocks the vascular endothelial growth factor receptor (VEGFR), the fibroblast growth factor receptor (FGFR), and the platelet derived growth factor receptor (PDGFR) signaling pathways, thereby exerting its anti-angiogenesis anti-cancer effect. Nintedanib was recently approved by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis under the brand name Ofev.
Boehringer Ingelheim today announced enrollment of the first patient in a new global Phase III study in patients with metastatic colorectal cancer (mCRC). Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. Prognosis is very poor for patients with mCRC with fewer than 10% surviving for more than five years after diagnosis.
LUME-COLON 1 is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of nintedanib plus best supportive care (BSC), versus placebo plus BSC, after previous treatment with standard chemotherapy and biological agents. This new study will build on previous Phase I/II studies evaluating nintedanib in mCRC. Nintedanib is an investigational compound in mCRC; its safety and efficacy have not been established.