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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 is a Phase 2 study that was terminated before completion, run by NuCana. The registered enrollment target is 180 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05678257
The ClinicalTrials.gov registry entry for NCT05678257 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NuCana, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Leucovorin is the first listed.
NCT05678257 reports 0 study locations.
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.
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