
Study design:
This study was conducted using an open-label, nonrandomized, 2-part phase Ib design and was carried out at 2 centers. The study population consisted of a dose escalation cohort (part 1) to establish the recommended phase II dose (RP2D) for biweekly administration of the combination of FTD/TPI, IRI, and BEV, and an expansion cohort (part 2) for further investigation of safety and provision of a preliminary assessment of the antitumor activity of the combination regimen at the RP2D in patients with mCRC in whom fluoropyrimidine and oxaliplatin treatment had failed.