Boston Biomedical has announced that the CanStem111P study investigating napabucasin in patients with metastatic pancreatic cancer will be discontinued due to futility.
The phase 3 study was evaluating the safety and efficacy of napabucasin plus weekly nab-paclitaxel with gemcitabine vs weekly nab-paclitaxel with gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma. According to the Company, the decision to discontinue the study was based on a recommendation by the independent Data and Safety Monitoring Board (DSMB) following a pre-specified interim analysis of futility at 50% of the total planned events.
“We are disappointed with the results of this interim analysis and would like to express gratitude to the trial participants, their families, investigators and staff for their efforts and contributions to this study,” said Patricia S. Andrews, CEO, Boston Biomedical.
Napabucasin is an orally administered cancer stemness inhibitor designed to target STAT3 signaling pathways, which is expected to result in cancer cell death. The investigational agent is currently being evaluated in the phase 3 CanStem303C trial for metastatic colorectal cancer. Additionally, it is being investigated in earlier phase trials in multiple solid malignancies.
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