Glucarpidase

Generic Name
Glucarpidase
Brand Names
Voraxaze
Drug Type
Biotech
Chemical Formula
-
CAS Number
9074-87-7
Unique Ingredient Identifier
2GFP9BJD79
Background

Glucarpidase is a recombinant carboxypeptidase G2 produced by genetically modified Escherichia coli bacteria. It is a 390-amino acid homodimer protein. High-dose methotrexate, an antifolate agent, has been widely and safely used for many decades in treating various cancers; however, even with aggressive hydration, urine alkalinization, and leucovorin rescue,...

Indication

Glucarpidase is indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per litre) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired...

Associated Conditions
Methotrexate toxicity
Associated Therapies
-

Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate

First Posted Date
2023-06-12
Last Posted Date
2024-05-10
Lead Sponsor
Protherics Medicines Development Limited
Target Recruit Count
1000
Registration Number
NCT05899751
Locations
🇪🇸

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR), Barcelona, Spain

🇫🇷

Assistance Publique Hôpitaux de Marseille (APHM), La Timone Hospital, Marseille, France

🇪🇸

Fundación Privada Instituto de Investigación Oncológica de Vall d'Hebron (VHIO), Barcelona, Spain

and more 2 locations

Dose Dense Re-challenge of High Dose Methotrexate With Glucarpidase for Relapsed Primary Central Nervous System Lymphoma

First Posted Date
2021-11-26
Last Posted Date
2022-10-25
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
18
Registration Number
NCT05135858
Locations
🇫🇷

Hôpital Pitié-Salpêtrière, Paris, France

HM-178: Assessing Methods for Improvement in Methotrexate Toxicity Management and Detection of Central Nervous System Involvement of Aggressive Lymphoma

Phase 2
Suspended
Conditions
Interventions
First Posted Date
2020-12-16
Last Posted Date
2024-03-22
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
3
Registration Number
NCT04668768
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma

Early Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-05-22
Last Posted Date
2024-08-21
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
12
Registration Number
NCT03960177
Locations
🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

🇺🇸

University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma

First Posted Date
2018-09-26
Last Posted Date
2024-08-26
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
64
Registration Number
NCT03684980
Locations
🇺🇸

Dana Farber Cancer Institute (Data Collection and Specimen Analysis), Boston, Massachusetts, United States

🇺🇸

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

and more 7 locations

Will Glucarpidase After Methotrexate Treatment for Bone Sarcoma Lead to Fewer Side Effects and Reduce Chemotherapy Delays?

First Posted Date
2013-12-27
Last Posted Date
2015-06-04
Lead Sponsor
University College, London
Target Recruit Count
34
Registration Number
NCT02022358
Locations
🇬🇧

University College Hospital, London, United Kingdom

Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-03-01
Last Posted Date
2018-09-28
Lead Sponsor
Nordic Society for Pediatric Hematology and Oncology
Target Recruit Count
47
Registration Number
NCT01305655
Locations
🇫🇮

Helsinki University Hospital, Helsinki, Finland

🇩🇰

Department of Pediatrics, Rigshospitalet, Copenhagen, Denmark

🇳🇴

University Hospital of Trondheim, Trondheim, Norway

and more 2 locations

Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

First Posted Date
2008-08-04
Last Posted Date
2014-01-27
Lead Sponsor
University College, London
Target Recruit Count
4
Registration Number
NCT00727831
Locations
🇬🇧

Leeds General Infirmary, Leeds, England, United Kingdom

🇬🇧

Torbay Hospital, Torquay, England, United Kingdom

High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2008-03-13
Last Posted Date
2014-09-15
Lead Sponsor
BTG International Inc.
Target Recruit Count
7
Registration Number
NCT00634322

Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate

First Posted Date
2003-01-27
Last Posted Date
2015-04-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
10
Registration Number
NCT00018967
Locations
🇺🇸

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

🇺🇸

Stanford Comprehensive Cancer Center - Stanford, Stanford, California, United States

🇺🇸

Children's National Medical Center, Washington, District of Columbia, United States

and more 100 locations
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