Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer.

ABSTRACT: Fruquintinib is a highly selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, approved by the US Food and Drug Administration and the European Commission for the treatment of previously treated metastatic colorectal cancer (mCRC), regardless of biomarker status. This study used concentration QT interval (C-QTc) modeling, utilizing data from the phase 3 FRESCO-2 study (NCT04322539) in which patients with mCRC received fruquintinib 5 mg, once daily, or matching placebo in a 28-day cycle, to evaluate the potential of fruquintinib to delay cardiac repolarization. The primary objectives were to assess the relationship between change from baseline in the QTc and plasma concentrations of fruquintinib and its metabolite M11, and to predict placebo-corrected change

SUBMITTER: Zhou X 

PROVIDER: S-EPMC12555101 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature