CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine.

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.

• Authors: Mohamad Bassam Sonbol, Daniel H Ahn, David Goldstein, Takuji Okusaka, Josep Tabernero, Teresa Macarulla, Michele Reni, Chung-Pin Li, Bert O'Neil, Eric Van Cutsem, Tanios Bekaii-Saab
• Journal: Future oncology (London, England) (Future Oncol) Vol. 15 Issue 12 Pg. 1295-1302 (Apr 2019) ISSN: 1744-8301 [Electronic] England
• PMID: 30768369 (Publication Type: Clinical Trial Protocol, Journal Article)

Chemical References

• 130-nm albumin-bound paclitaxel
• Albumins
• Benzofurans
• Naphthoquinones
• napabucasin
• Deoxycytidine
• Paclitaxel
• Gemcitabine

Topics

• Administration, Oral
• Adult
• Albumins (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Benzofurans (administration & dosage, adverse effects)
• Carcinoma, Pancreatic Ductal (drug therapy, mortality)
• Clinical Trials, Phase III as Topic
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Drug Administration Schedule
• Humans
• Multicenter Studies as Topic
• Naphthoquinones (administration & dosage, adverse effects)
• Paclitaxel (administration & dosage, adverse effects)
• Pancreatic Neoplasms (drug therapy, mortality)
• Progression-Free Survival
• Randomized Controlled Trials as Topic
• Young Adult
• Gemcitabine