drugset
drugset / Trial / NCT02753127

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

NCT02753127 ↗

Phase 3 Completed 1253 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2016-06
Primary completion
2020-04-28
Completion
2021-05-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Napabucasin Small molecule 240 mg Oral
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 1200 mg/m2 Intravenous

Indications

colorectal cancer