At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
glucarpidase, high-dose methotrexate, leucovorin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
In Brief
A Phase 1 clinical trial evaluating glucarpidase, high-dose methotrexate, leucovorin and high-dose methotrexate, leucovorin for Osteosarcoma and 2 related conditions. Completed, enrolled 20 participants across 25 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteosarcoma, Leukemia, Lymphoma
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartMay 2008
Primary CompletionAug 2009
TodayJul 2026
First PostedMar 13, 2008
Enrollment StartMay 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago
Interventions
glucarpidase, high-dose methotrexate, leucovorindrug
single intravenous dose
high-dose methotrexate, leucovorindrug
standard of care, leucovorin every 6 hours