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NCT05678257 · ClinicalTrials.gov registry record · Phase 2
A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer
A Phase 2 study, sponsored by NuCana.
- Terminated
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT05678257: Clinical Trial Phase 2 study, sponsored by NuCana.
NCT05678257 is a Phase 2 study that was terminated before completion, run by NuCana. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05678257, a Phase 2 study, was terminated before completion, sponsored by NuCana.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study 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.
Primary Outcome
PFS assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, defined as the time from randomisation to the first observation of objective tumour progression or death from any cause. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.
Interventions
- DRUG Leucovorin
- DRUG Irinotecan
- BIOLOGICAL Bevacizumab
- DRUG 5-FU
- DRUG Fosifloxuridine Nafalbenamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-04-18 |
| Est. Completion | 2024-08-29 |
| Phase | Phase 2 |
Why NCT05678257 stopped before completion
NCT05678257 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 5 interventions - of which Leucovorin is the first listed.
NCT05678257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05678257 about?
NCT05678257 is a clinical study titled "A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer". 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 w...
What is the current status of trial NCT05678257?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2023-04-18. Estimated completion is 2024-08-29.
What interventions are being tested in trial NCT05678257?
The interventions under investigation include: Leucovorin (DRUG), Irinotecan (DRUG), Bevacizumab (BIOLOGICAL), 5-FU (DRUG), Fosifloxuridine Nafalbenamide (DRUG).
Who is sponsoring clinical trial NCT05678257?
This trial is sponsored by NuCana, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05678257's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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