A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
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.