drugset / Trial / NCT04126655
Modelle 001, TS-inhibition in Colorectal Liver Metastases Comparing Arfolitixorin and Calciumfolinate
RandomizedParallel-groupTriple-blindTreatment
Summary
A study that is blinded to the patient and the investigator where the combination of Arfolitixorin + 5-FU is compared to Calciumfolinate + 5-FU. The patients will be randomised and will receive the above described combination as IV bolus injections, peroperatively in conjuction with collection of the first tissue sample. A low dose (30 mg) and a high dose (120) mg of Arfolitixorin will be used in order to investigate the relation between dose of Arfolitixorin and TS-inhibition.
Timeline
- Start
- 2020-02-05
- Primary completion
- 2021-10
- Completion
- 2021-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arfolitixorin | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Arfolitixorin | Small molecule | 120 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 60 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 250 mg/m2 | Intravenous |