Featured Phase III Research: The BRIGHTER Trial
Active. Not Recruiting.
A Phase III Study of Napabucasin (BBI608) Plus Weekly Paclitaxel to Treat Gastric and Gastroesophageal Junction (GEJ) Cancer
*Napabucasin 480 mg PO BID
✝ Paclitaxel 80 mg/m2 IV 3 out of 4 weeks
Key Inclusion Criteria
- Cytologically or histopathologically confirmed advanced gastric or GEJ adenocarcinoma that is metastatic or locally advanced and unresectable
- Failed treatment with one regimen containing at least a platinum/fluoropyrimidine doublet for unresectable or metastatic disease. Treatment failure is defined as progression of disease (clinical or radiologic) during first-line treatment for unresectable or metastatic disease, or ≥ 6 months after last dose of first-line treatment
- Paclitaxel therapy is appropriate for the patient and is recommended by the investigator
Global sites currently include Australia, Belgium, Brazil, Canada, Czech Republic, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Lithuania, Poland, Romania, Russian Federation, Spain, United Kingdom, and the United States.‡
Napabucasin is an orally administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.
Preliminary results of napabucasin plus paclitaxel as second-line therapy in patients with advanced gastric and GEJ adenocarcinoma were published as a poster at the ASCO Annual Meeting 2015. Click here to download the poster. Napabucasin is an investigational agent and not approved by the US FDA.
‡Study locations noted above are as of May 2016
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