Phase 3 Study on Metastatic Colorectal Cancer Enrolls First Patient

Phase 3 Study on Metastatic Colorectal Cancer Enrolls First Patient

shutterstock_173814836A new global Phase 3 clinical study to treat patients with metastatic colorectal cancer (mCRC), has enrolled its first patient, as announced Boehringer Ingelheim Pharmaceuticals Inc. (BI).

Colorectal cancer is the third most common cancer in the world, and its prognosis is extremely poor. Every year, approximately 1.4 million cases are diagnosed. Once mCRC cancer is confirmed, less than 10% of the patients survive for longer than 5 years.

Nintedanib is an investigational compound for the treatment of mCRC, however its efficacy and safety are not established yet. Nintedanib is going to be evaluated (concerning safety and efficiency) in LUME-COLON 1, a double-blind, randomized study assessing nintedanib plus best supportive care (BSC) versus placebo plus BSC after a previous treatment with standard chemotherapy and biological agents. BSC is the best palliative care according to researchers. This new phase of the trial is based on previous studies (Phase 1 and 2) that evaluated nintedanib in mCRC.

“Based on previous clinical studies with nintedanib, BI will initiate the LUME-COLON 1 study to evaluate this compound as a potential treatment option for patients with refractory colorectal cancer (…) Patient needs are the driving force behind BI’s innovation in cancer research, and the initiation of this global Phase 3 study represents our commitment to addressing a critical need in the colorectal cancer community,” Berthold Greifenberg, M.D., vice president, clinical development and medical affairs, oncology, Boehringer Ingelheim, said in a company’s press release.

Patients, if diagnosed early with localized CRC, can have a five-year survival rate of 93%;  on the contrary, for those with mCRC the chances drop down to less that 10%. Thus, effective screening and early diagnosis are crucial to reduce the tragic consequences of the disease. There is an urgent need for new treatments directed towards patients suffering with the advanced form of the disease.

LUME-COLON 1 will join more than 750 mCRC patients whose disease has progressed on previous treatment. The trial will be conducted at 150 investigational sites worldwide, including the United States, Europe and Asia. Patients will receive either nintedanib plus BSC or placebo plus BSC. The primary endpoints are set to progression-free survival (PFS) and overall survival (OS); the secondary endpoints are objective tumor response rate and disease control rate.

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