A Trial of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer (mCRC)
Key Inclusion Criteria
- Age ≥18 years
- ECOG PS 0 or 1
- Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic
- Failed treatment with a minimum of 6 weeks of firstline combination therapy for metastatic disease that included bevacizumab (if applicable), 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="" li="">
- FOLFIRI therapy is appropriate for the patient and is recommended by the Investigator
See www.clinicaltrials.gov for comprehensive eligibility criteria.
Global sites in Asia, North America, and Europe, including Japan and the US, are actively recruiting. Please check www.clinicaltrials.gov for updates about this study (NCT02753127) and for a listing of clinical study site locations.
Napabucasin is an investigational, orally administered agent hypothesized to inhibit cancer stemness pathways, and has not yet been approved by the FDA or any other health authorities.
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 1.1=Response Evaluation Criteria in Solid Tumors version 1.1; ECOG PS=Eastern Cooperative Oncology Group Performance Status.