3C-14-5: A Double-blind, Randomized, Placebo Controlled Phase III Study of Nintedanib plus Best Supportive Care (BSC) versus Placebo plus BSC in Patients with Colorectal Cancer Refractory to Standard Therapies
Colorectal cancer is the second leading cause of cancer-related deaths in Western countries. About half of patients eventually develop metastatic disease. Virtually all patients with advanced metastatic colorectal cancer will sooner or later become refractory to standard treatment, and will eventually succumb to their disease.
Despite clinical advances reported in the treatment of metastatic colorectal cancer by using combination of chemotherapy and targeted therapies, there is need for more effective agents for patients with refractory metastatic colorectal cancer.
VEGFR-2 is considered the crucial molecule involved in formation as well as the maintenance of tumor. Nintedanib is a potent small molecule inhibiting VEGFR receptor family, leading to anti-tumor effects.
The purpose/objective of this study is to evaluate the efficacy and safety of nintedanib in
patients with metastatic colorectal cancer after failure of previous treatment with standard chemotherapy and biological agents.
Study participants will be randomly assigned in a 1:1 ratio to receive either nintedanib + best supportive care (Arm A) or matching placebo + best supportive care (Arm B). Best supportive care that is considered standard treatment option after failure of approved available anti-cancer treatments.
Participants will receive study treatment until unequivocal progression or undue toxicity; no other anti-cancer treatment will be allowed until study drug is discontinued.
Evaluation of tumor response will be assessed by imaging every 6 weeks. The investigators decision about continuation of study treatment will be based on assessment of tumor response and progression.
Not recruiting | Colon / Rectal Cancer | Multisite
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