A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer
Public ClinicalTrials.gov record NCT05678257. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05678257
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Interventions
- Fosifloxuridine Nafalbenamide Drug
- Leucovorin Drug
- Irinotecan Drug
- Bevacizumab Biological
- 5-FU Drug
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 18, 2023 (Actual)
- Primary completion
- Aug 29, 2024 (Actual)
- Completion
- Aug 29, 2024 (Actual)
- Last update posted
- Sep 12, 2025
2023 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Helen F. Graham Cancer Center | Newark | Delaware | 19713 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| University of Florida Health Medical Oncology - Davis Cancer Pavilion | Gainesville | Florida | 32610 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| University of Massachusetts Worcester | Worcester | Massachusetts | 01655 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | 45219 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| USOR - Texas Oncology Northeast Texas | Tyler | Texas | 75702 | — |
| Fred Hutchinson Cancer Center at Evergreen Health | Kirkland | Washington | 98034 | — |
| Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05678257, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 12, 2025 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05678257 live on ClinicalTrials.gov.