Napabucasin (also known as BBI-608 or BBI608) is an investigational, oral agent hypothesized to inhibit multiple oncogenic pathways. In this article, we describe the design and rationale for the CanStem111P clinical trial, a multicenter, randomized, open-label, Phase III study designed to determine the efficacy and safety of combining napabucasin with nab-paclitaxel and gemcitabine for first-line treatment of patients with metastatic pancreatic adenocarcinoma (NCT02993731). Patients were randomized in a 1:1 fashion to receive weekly gemcitabine and nab-paclitaxel with or without napabucasin. The results of this study will help define the role of this novel agent in the management of advanced pancreatic cancer.
CanStem111P trial: A Phase III study of napabucasin plus nab-paclitaxel with gemcitabine / Sonbol, M. B.; Ahn, D. H.; Goldstein, D.; Okusaka, T.; Tabernero, J.; Macarulla, T.; Reni, M.; Li, C. -P.; O'Neil, B.; Van Cutsem, E.; Bekaii-Saab, T.. - In: FUTURE ONCOLOGY. - ISSN 1479-6694. - 15:12(2019), pp. 1295-1302. [10.2217/fon-2018-0903]
CanStem111P trial: A Phase III study of napabucasin plus nab-paclitaxel with gemcitabine
Reni M.;
2019-01-01
Abstract
Napabucasin (also known as BBI-608 or BBI608) is an investigational, oral agent hypothesized to inhibit multiple oncogenic pathways. In this article, we describe the design and rationale for the CanStem111P clinical trial, a multicenter, randomized, open-label, Phase III study designed to determine the efficacy and safety of combining napabucasin with nab-paclitaxel and gemcitabine for first-line treatment of patients with metastatic pancreatic adenocarcinoma (NCT02993731). Patients were randomized in a 1:1 fashion to receive weekly gemcitabine and nab-paclitaxel with or without napabucasin. The results of this study will help define the role of this novel agent in the management of advanced pancreatic cancer.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.