drugset / Trial / NCT00634504

Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze

NCT00634504

Phase 1 Completed 20 enrolled BTG International Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.

Timeline

Start
2008-05
Primary completion
2009-08
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Glucarpidase Protein / enzyme biologic Intravenous
Subject Leucovorin Small molecule Intravenous
Background Methotrexate Small molecule Intravenous