Featured Phase III Research: The CanStem111P Trial
A Study of Napabucasin (BBI-608) Plus Weekly Nab-paclitaxel With Gemcitabine Versus Weekly Nab-paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
*If no other standard therapies are available at the time of disease progression based on RECIST 1.1, and the patient has not experienced any adverse events requiring permanent discontinuation, napabucasin may be continued in monotherapy.
†Defined as those patients with nuclear β-catenin and phospho-STAT3 positivity on immunohistochemical staining of formalin-fixed, paraffin-embedded (FFPE) tumor tissue.
Key Inclusion Criteria
- Histologically or cytologically confirmed metastatic PDAC
- Diagnosed ≤6 weeks prior to randomization
- Not received systemic chemotherapy in the metastatic setting
- Weekly nab-paclitaxel and gemcitabine must be an acceptable treatment option
IV=intravenously; RECIST 1.1=Response Evaluation Criteria in Solid Tumors version 1.1.
Sites in the US are actively recruiting with additional sites globally being identified. Please check www.clinicaltrials.gov for updates about this study (NCT02993731) and for a listing of clinical study site locations.
Napabucasin is an orally administered, investigational, cancer stemness inhibitor, not approved by the FDA, designed to inhibit cancer stemness pathways by targeting STAT3.