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Completed Phase 1 Interventional Results available

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

ClinicalTrials.gov ID: NCT00634504

Public ClinicalTrials.gov record NCT00634504. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 1, 2026, 8:04 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00634504
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
BTG International Inc.
Other
Enrollment
20 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2008 (Type not available)
Primary completion
Aug 2009 (Actual)
Completion
Aug 2009 (Actual)
Last update posted
Jun 6, 2022

2008 – 2009

United States locations

U.S. sites
25
U.S. states
19
U.S. cities
23
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 —
Good Samaritan Hospital Los Angeles California 90017 —
Children's Hospital of Los Angeles Los Angeles California 90027 —
Children's Hospital of Orange County Los Angeles California 92868 —
Oakland's Children's Hospital Oakland California 94609 —
Stanford University Medical Center & Lucile Packard Children's Hospital Palo Alto California 94304-1812 —
California Pacific Medical Center San Francisco California 94115 —
Children's Hospital for Cancer & Blood Disorders Aurora Colorado 80045 —
St. Joseph's Hospital Tampa Florida 33607 —
NorthShore University Health System Evanston Illinois 60201 —
Riley Hospital for Children Indianapolis Indiana 46202 —
University of Kentucky Lexington Kentucky 40536 —
University of Massachusetts - Umass Memorial Medical Center Worcester Massachusetts 04655 —
University of MS Medical Center Jackson Mississippi 39216 —
University of Missouri-Columbia Columbia Missouri 65212 —
Washington University Medical Center St Louis Missouri 63110 —
St. Elizabeth Regional Medical Center Lincoln Nebraska 68506 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
ECU Brody School of Medicine Greenville North Carolina 27834 —
Gabrail Cancer Center Canton Ohio 44718 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
St. Jude Children's Research Hospital Memphis Tennessee 38105 —
Texas Children's Hospital Houston Texas 77030 —
Huntsman Cancer Center Salt Lake City Utah 84112 —
Children's Hospital and Regional Medical Center Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00634504, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 6, 2022 · Synced Nov 1, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00634504 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →