A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
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
Outcome
Missed primary endpoint
registry analysis (superiority test); Napabucasin + FOLFIRI ± Bevacizumab vs FOLFIRI ± Bevacizumab; p = 0.3629; Hazard Ratio (HR) 0.976 (95% CI 0.854 to 1.117); NCT02753127 ↗
release “CanStem303C study evaluating the safety and efficacy of investigational anticancer agent napabucasin (generic name; development code, BBI608; hereafter, "napabucasin") failed to reach the primary endpoints.” sumitomo-pharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |