A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer

Complete Title: A randomised, open-label, Phase II, dose/schedule optimisation study of NUC-373/leucovorin/irinotecan plus bevacizumab (NUFIRI-bev) versus 5-/leucovorin/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with previously treated unresectable metastatic colorectal cancer

Trial Phase: II

Investigator: Andrew Coveler

This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer. A total of 171 patients will be randomized 1:1:1 to either NUFIRI-bev on a weekly NUC-3373 schedule, NUFIRI-bev based on an alternate weekly NUC-3373 schedule, or FOLFIRI bev on an alternate weekly schedule. The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.

Keywords:

Colorectal Neoplasms

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