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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BTG International Inc.
• Treatments: Leucovorin; Levoleucovorin; Methotrexate

Criteria

Inclusion Criteria:

• Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination

• Require intravenous leucovorin

Exclusion Criteria:

• Arm A only: allergic reactions to lactose

• Arm A only: hereditary fructose or galactose intolerance

• Arm B only: delayed elimination of MTX