Trials / Completed
CompletedNCT00634504
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- BTG International Inc. · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | glucarpidase, high-dose methotrexate, leucovorin | single intravenous dose |
| DRUG | high-dose methotrexate, leucovorin | standard of care, leucovorin every 6 hours |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2009-08-01
- Completion
- 2009-08-01
- First posted
- 2008-03-13
- Last updated
- 2022-06-06
- Results posted
- 2014-07-03
Locations
25 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00634504. Inclusion in this directory is not an endorsement.