drugset / Trial / NCT01987102

Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX.

NCT01987102

Phase 1/2 Completed 18 enrolled Isofol Medical AB
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

EvaluationDrugModalityDoseRoute
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

Indications