At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,253 enrolled
Drug / intervention
Napabucasin +4 moredrug
Likely dose
Napabucasin 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 3 clinical trial evaluating Napabucasin, Fluorouracil, and 3 other interventions for Colorectal Cancer. Completed, enrolled 1,253 participants across 211 sites in 16 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesAustralia, Belgium, Canada, China, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Singapore, South Korea, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionApr 2020
Study CompletionMay 2021
TodayJul 2026
First PostedApr 27, 2016
Enrollment StartJun 1, 2016
Primary CompletionApr 28, 2020
Study CompletionMay 12, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.2 years ago
Interventions
Napabucasindrug
Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).
Fluorouracildrug
Leucovorindrug
Irinotecandrug
Bevacizumabdrug