Vargatef in new Phase III trial for Colorectal Cancer-Boehringer

Boehringer announced enrollment of the first patient in a new global Phase III study of Vargatef (nintedanib) in patients with metastatic Colorectal Cancer (mCRC). LUME-COLON 1 [NCT02149108] 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. LUME-COLON 1 will enroll more than 750 patients with mCRC whose disease has progressed on previous treatment and will be conducted at 150 sites worldwide, with locations in the U.S., Europe and Asia, among others. Patients will receive either nintedanib plus BSC, or matching placebo plus BSC. BSC is defined as the best palliative care per investigator decision. The co-primary endpoints will be progression-free survival (PFS), evaluated by blinded review, and overall survival (OS). The secondary endpoints are objective tumor response rate and disease control rate.