A Phase III Study Of BBI-608 In Combination With 5-Fluorouracil, Leucovorin, Irinotecan (Folfiri) In Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)
Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active
In this study, adult patients with metastatic CRC following progression on first-line FOLFOX or XELOX with or without bevacizumab will be randomized in a 1:1 ratio to BBI-608 plus biweekly FOLFIRI or biweekly FOLFIRI. Addition of bevacizumab to the FOLFIRI regimen, per Investigator choice, will be permissible. Patients will be stratified according to geographical region (North America/Western Europe/Australia, vs. Japan/Korea vs. rest of the world); time to progression from start of first line therapy (<6 months vs. ?6 months); RAS mutation status (mutant vs. wild type), and bevacizumab as part of their protocol treatment (yes vs. no) and location of the primary tumor (left vs. right colon).
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