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Published on: May 14, 2018
CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine
Mohamad Bassam Sonbol1, Daniel H Ahn1, David Goldstein2
1Mayo Clinic Cancer Center, Mayo Clinic, Phoenix, AZ 85054, USA.
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.
Insights
Napabucasin, an investigational oral agent, was studied in combination with standard chemotherapy for advanced pancreatic cancer. This trial assessed its efficacy and safety as a first-line treatment option.
Area of Science:
- Oncology
- Clinical Trials
- Drug Development
Background:
- Napabucasin is an investigational oral agent targeting multiple oncogenic pathways.
- Metastatic pancreatic adenocarcinoma remains a significant challenge in cancer treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of napabucasin combined with nab-paclitaxel and gemcitabine.
- To determine the role of napabucasin in the first-line treatment of metastatic pancreatic cancer.
Main Methods:
- A multicenter, randomized, open-label, Phase III clinical trial (CanStem111P).
- Patients received weekly gemcitabine and nab-paclitaxel with or without napabucasin (1:1 randomization).
Main Results:
- The study aimed to determine the efficacy and safety of the combination therapy.
- Results will inform the clinical utility of napabucasin in advanced pancreatic cancer management.
Conclusions:
- The CanStem111P trial will provide crucial data on napabucasin's potential in treating metastatic pancreatic cancer.
- Findings will help define the role of this novel agent in the therapeutic landscape.
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