Tanios Bekaii-Saab, MD
Napabucasin, a novel therapy that targets cancer stem cell (CSC) pathways, is being investigated in a phase III clinical trial that is believed to be the largest study ever conducted in pancreatic ductal adenocarcinoma (PDAC) in the metastatic setting, according to Tanios S. Bekaii-Saab, MD.
Nearly 1200 patients have enrolled in the CanStem111P trial, which recruited participants at approximately 300 study sites, Bekaii-Saab, a key investigator in the trial, said in an interview with OncologyLive®
. Findings are expected late this year or early next year, depending on there being enough events to analyze outcomes, said Bekaii-Saab, a senior associate consultant in the Division of Hematology/Oncology and a professor of medicine at Mayo Clinic in Phoenix, Arizona.
CanStem111P (NCT02993731)1 is evaluating nab-paclitaxel (Abraxane) plus gemcitabine with and without napabucasin in patients with ≥1 metastatic tumors who have not received chemotherapy for PDAC. Patients in the experimental arm are administered 240-mg napabucasin orally twice daily in combination with weekly nab-paclitaxel at 125 mg/m2
plus gemcitabine at 1000 mg/m2 intravenously once weekly, in 3 of every 4 weeks (Figure
Those in the active comparator arm receive nab-paclitaxel plus gemcitabine, which is the current standard of care for PDAC. The primary endpoint is overall survival (OS).
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