Phase 1
Completed N=20
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
Source: ClinicalTrials.gov NCT00634504 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Jul 2014
Primary outcomePrimary: Pharmacokinetics (PK) of Leucovorin — 6.43; 1.13 micromol x hour/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK) of Leucovorin |
6.43; 1.13 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00634504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.