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. See ClinicalTrials.gov for further information.
†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.
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 for metastatic disease that included bevacizumab, oxaliplatin, and a fluoropyrimidine in the same cycle. 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-fl uorouracil 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 in the US and globally are actively recruiting participants. Please check www.clinicaltrials.gov for updates about this study (NCT02753127) and for a listing of clinical study site locations.
Napabucasin, an investigational agent, is an orally administered cancer stemness inhibitor. Napabucasin has not been approved by the FDA or any other health authorities.