drugset / Trial / NCT03428958
A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a three-part study of NUC-3373 administered by intravenous (IV) infusion across two administration schedules, either as monotherapy or as part of various combinations with agents commonly used to treat CRC (leucovorin, oxaliplatin, irinotecan, bevacizumab, cetuximab and panitumumab). The primary objective is to identify a recommended dose and schedule for NUC-3373 when combined with these agents.
Timeline
- Start
- 2018-10-05
- Primary completion
- 2024-03-19
- Completion
- 2024-03-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Cetuximab | Monoclonal antibody | — | — |
| Subject | Fosifloxuridine Nafalbenamide | Other / unclassified | — | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Panitumumab | Monoclonal antibody | — | — |