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A Randomised, Open-label, Phase II, Dose/Schedule Optimisation Study of NUC-3373/Leucovorin/Irinotecan Plus Bevacizumab (NUFIRI-bev) Versus 5-FU/Leucovorin/Irinotecan Plus Bevacizumab (FOLFIRI-bev) for the Treatment of Patients With Previously Treated Unresectable Metastatic Colorectal Cancer

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Trial Profile

A Randomised, Open-label, Phase II, Dose/Schedule Optimisation Study of NUC-3373/Leucovorin/Irinotecan Plus Bevacizumab (NUFIRI-bev) Versus 5-FU/Leucovorin/Irinotecan Plus Bevacizumab (FOLFIRI-bev) for the Treatment of Patients With Previously Treated Unresectable Metastatic Colorectal Cancer

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 21 Sep 2024

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At a glance

  • Drugs Fosifloxuridine nafalbenamide (Primary) ; Bevacizumab; Fluorouracil; Folinic acid; Irinotecan; Levofolinic acid
  • Indications Adenocarcinoma; Carcinoma; Colorectal cancer
  • Focus Therapeutic Use
  • Acronyms NuTide 323
  • Sponsors NuCana

Most Recent Events

  • 02 Sep 2024 Status changed from active, no longer recruiting to discontinued.
  • 29 Aug 2024 According to a NuCana media release, the study is being discontinued following a pre-planned initial analysis and recommendation from the NuTide:323 Study Steering Committee. While there were prognostic imbalances favoring the control arm, the Steering Committee believed that the combination of NUC-3373 with leucovorin, irinotecan and bevacizumab (NUFIRI+bev) was unlikely to achieve the study's primary objective of superior Progression Free Survival (PFS) compared to the control arm.
  • 02 Apr 2024 Status changed from recruiting to active, no longer recruiting.

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