Featured Phase III Research: The CanStem303C Trial
A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer (mCRC)
Addition of bevacizumab to the FOLFIRI regimen, per Investigator choice, will be permissible.
*Addition of bevacizumab to the FOLFIRI regimen, per Investigator choice, will be permissible.
†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/or phospho-STAT3 positivity on immunohistochemical (IHC) staining of formalin-fixed, paraffin-embedded (FFPE) archival tissue.
Key Inclusion Criteria
- Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic
- Failed treatment with a minimum of 6 weeks of first-line combination therapy containing oxaliplatin and a fluoropyrimidine with or without bevacizumab for metastatic disease. Treatment failure is defined as radiologic progression during or <6 months after the last dose of first-line treatment
- FOLFIRI therapy is appropriate for the patient and is recommended by the Investigator
FOLFIRI=5-fluorouracil 400 mg/m2 bolus followed by 1200 mg/m2/day continuous infusion, leucovorin 400 mg/m2, and irinotecan 180 mg/m2.
IV=intravenously; RECIST=Response Evaluation Criteria in Solid Tumors.
Sites are currently open for enrollment in the United States and Japan. Other ex-US sites are currently being identified. Please check www.clinicaltrials.gov for updates about this study (NCT02753127) 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 stem cell pathways by targeting STAT3.