NCT02753127

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,253 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Napabucasin	Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).
DRUG	Fluorouracil
DRUG	Leucovorin
DRUG	Irinotecan
DRUG	Bevacizumab

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-04-28
• Completion: 2021-05-12
• First posted: 2016-04-27
• Last updated: 2023-11-15
• Results posted: 2022-04-26

Locations

211 sites across 16 countries: United States, Australia, Belgium, Canada, China, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Singapore, South Korea, Spain