On June 6, 2019 Boston Biomedical, Inc. reported the continuation of the CanStem303C study evaluating the safety and efficacy of investigational agent napabucasin when given in combination with FOLFIRI with or without bevacizumab in patients with advanced colorectal cancer (Press release, Boston Biomedical, JUN 6, 2019, View Source [SID1234536936]). This decision is based on a recommendation by the independent Data and Safety Monitoring Board (DSMB) to continue the study without modification following a pre-specified interim analysis of 50 percent of the total planned events. Boston Biomedical, Inc. has accepted this recommendation.
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About Napabucasin
Napabucasin is an orally-administered investigational agent that is bioactivated by NQO1, which generates reactive oxygen species (ROS) to affect multiple oncogenic cellular pathways, including the STAT3 pathway, which is expected to result in cancer cell death.1
Napabucasin is currently being investigated in CanStem303C, a phase 3 trial for metastatic colorectal cancer (NCT02753127) and CanStem111P, a phase 3 trial for metastatic pancreatic cancer (NCT02993731). It is also being investigated in earlier phase trials in multiple solid malignancies. In 2016, the U.S. Food and Drug Administration granted Orphan Drug Designation for napabucasin in pancreatic cancer.