drugset / Trial / NCT01987102
Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX.
Non-randomizedSequentialOpen-labelTreatment
Summary
An open-label, multicenter, phase I/II clinical trial to identify the \[6R\] 5,10-methylenetetrahydrofolate (arfolitixorin) dose with most favorable safety prospect and confirmed ability to mitigate high-dose methotrexate induced toxicity during treatment of osteosarcoma patients
Timeline
- Start
- 2013-12
- Primary completion
- 2017-01-03
- Completion
- 2017-01-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arfolitixorin | Small molecule | 7.5 mg/m2 | — |
| Subject | Arfolitixorin | Small molecule | 15 mg/m2 | — |
| Subject | Arfolitixorin | Small molecule | 30 mg/m2 | — |
| Background | Leucovorin | Small molecule | 15 mg/m2 | — |