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Boston Biomedical initiates phase 3 study of napabucasin for pancreatic cancer
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Boston Biomedical initiated a global phase 3 study that will evaluate napabucasin in combination with standard of care for treatment of metastatic pancreatic cancer.
Napabucasin (BBI608) is an orally administered, first-in-class investigational agent designed to inhibit cancer stemness pathways by targeting STAT3, according to a Boston Biomedical–issued press release.
The CanStem111P study will be designed to include 1,132 previously untreated patients.
Researchers will randomly assign half of the study participants to 240 mg napabucasin twice daily in combination with nab-paclitaxel plus gemcitabine once weekly for 3 of every 4 weeks. The other half of study participants will receive nab-paclitaxel plus gemcitabine alone.
OS will serve as the primary endpoint. PFS, objective response rate, disease control rate, safety and quality of life will serve as secondary endpoints.
Researchers will assess OS, PFS, ORR and disease control rate in the general study population, as well as in biomarker-positive patients.
“We look forward to continuing the study of napabucasin in combination with standard-of-care therapy in metastatic pancreatic cancer patients, which has demonstrated encouraging antitumor activity in earlier clinical trials,” Chiang J. Li, MD, FACP, president, CEO and chief medical officer of Boston Biomedical, as well as head of global oncology for Sumitomo Dainippon Pharma Group, said in the press release. “Through this study, we are committed to gathering a deeper understanding of napabucasin's therapeutic benefits and the potential of cancer stemness inhibitors for treating this devastating disease.”
Napabucasin also is under investigation in phase 3 studies for the treatment of advanced gastric, gastroesophageal junction, colorectal and pancreatic cancers. Other studies are underway to evaluate the agent for the treatment of hematologic malignancies and solid tumors, including tumors of the lung, liver, pancreas and brain.