crofelemer in CTD

Treatment of cancer therapy–related diarrhea (CTD) is the focus of Napo Pharmaceuticals’ OnTarget phase 3 trial. A significant proportion of patients undergoing cancer therapy experience diarrhea, and diarrhea has the potential to cause dehydration, potential infections, and nonadherence to treatment in this population. Novel “targeted cancer therapy” agents, such as epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs), with or without cycle chemotherapy agents, may cause increased electrolyte and fluid content in the gut lumen, which results in passage of loose/watery stools (ie, diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs and may result in cancer therapy drug holidays or reductions from therapeutic dose, potentially impacting patient outcome. Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors.

OnTarget phase 3
clinical trial

Napo Pharmaceuticals is conducting a global, pivotal Phase 3 clinical trial evaluating crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without chemotherapy. The national principal investigator is at MD Anderson Cancer Center. Patient enrollment is expected to complete in Q2 2023.

References: 1. Stein A, Voigt W, Jordan K. Chemotherapy-induced diarrhea: pathophysiology, frequency and guideline-based management. Ther Adv Med Oncol. 2010;2(1):51-63. doi: 10.1177/1758834009355164 2. Wilson B, Jacob S, Yap M, et al. Estimates of global chemotherapy demands and corresponding physician workforce requirements for 2018 and 2040; a population-based study. Lancet Oncol. 2019;20(6):769-780. doi:10.1016/S1470-2045(19)30163-9 3. Okhuysen PC, Schwartzberg LS, Roeland E, et al. The impact of cancer-related diarrhea on changes in cancer therapy patterns. J Clin Oncol. 2021;39(15):12111. doi:10.1200/JCO.2021.39.15_suppl.12111