An announcement was made from Boston Biomedical Inc., regarding CanStemIIIP study for accessing the safety and efficacy of an investigational agent. Napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine study in patients with metastatic pancreatic ductal adenocarcinoma will be stopped due to futility.
This decision is based on recommendation by the independent Data and Safety Monitoring Board (DSMB), following a pre-specified interim analysis of futility at 50 percent of the total planned events. No new concerns regarding safety were raised by the DSMB.
Boston Biomedical has the intention to work with study investigators to complete a full examination of CanStem111P trial results. The data and analysis part of this study will be shared to regulatory authorities and will be presented and published for the oncology community for the reference.
Napabucasin is administered orally and they are investigational agent which is bioactivated by NQO1, which helps in generation of reactive oxygen species (ROS) to affect multiple oncogenic cellular pathways, including the STAT3 pathway, which is expected to cancer cell death.
Napabucasin is being investigated in CanStem303C which is a phase 3 trial for metastatic colorectal cancer (NCT02753127). It is also being investigated in earlier phase trials in multiple solid malignancies.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
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