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

NCT00634504 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-06

Study results available
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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

DRUG

glucarpidase, high-dose methotrexate, leucovorin

single intravenous dose

DRUG

high-dose methotrexate, leucovorin

standard of care, leucovorin every 6 hours

Sponsors & Collaborators

  • BTG International Inc.

    lead OTHER

Principal Investigators

  • Andrew Saunders, MD

  • Suzanne Kincaid, CCRA · BTG International Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634504 on ClinicalTrials.gov