Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
LVPK
An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
1 other identifier
interventional
20
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2008
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
July 3, 2014
CompletedJune 6, 2022
May 1, 2022
1.3 years
March 6, 2008
June 4, 2014
May 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics (PK) of Leucovorin
Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.
5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration
Study Arms (2)
A
EXPERIMENTALHigh-dose methotrexate, leucovorin, and Voraxaze
B
ACTIVE COMPARATORHigh-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
Interventions
single intravenous dose
standard of care, leucovorin every 6 hours
Eligibility Criteria
You may qualify if:
- Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
- Require intravenous leucovorin
You may not qualify if:
- Arm A only: allergic reactions to lactose
- Arm A only: hereditary fructose or galactose intolerance
- Arm B only: delayed elimination of MTX
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Good Samaritan Hospital
Los Angeles, California, 90017, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Orange County
Los Angeles, California, 92868, United States
Oakland's Children's Hospital
Oakland, California, 94609, United States
Stanford University Medical Center & Lucile Packard Children's Hospital
Palo Alto, California, 94304-1812, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Children's Hospital for Cancer & Blood Disorders
Aurora, Colorado, 80045, United States
St. Joseph's Hospital
Tampa, Florida, 33607, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Massachusetts - Umass Memorial Medical Center
Worcester, Massachusetts, 04655, United States
University of MS Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, 68506, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
ECU Brody School of Medicine
Greenville, North Carolina, 27834, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Huntsman Cancer Center
Salt Lake City, Utah, 84112, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- SVP, Clinical Development
- Organization
- BTG International Inc.
Study Officials
- STUDY CHAIR
Andrew Saunders, MD
- STUDY DIRECTOR
Suzanne Kincaid, CCRA
BTG International Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2008
First Posted
March 13, 2008
Study Start
May 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
June 6, 2022
Results First Posted
July 3, 2014
Record last verified: 2022-05