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Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481559
First Posted: June 1, 2007
Last Update Posted: January 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
BTG International Inc.
May 30, 2007
June 1, 2007
January 17, 2014
 
Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity
This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function

This treatment protocol will be available on a cost recovery basis to IRB-approved Investigators treating an eligible patient at any site in the US. In order to continue to make Voraxaze™ available following FDA approval and prior to being commercially available. Protherics needs to charge for the product, so there will be a cost to obtain Voraxaze™ under the Open-Label Treatment Protocol. Protherics is permitted under the FDA regulations (21 CFR 312.8) to charge for Voraxaze, to recover those costs associated with its manufacture, research and development, and handling, but do not include other commercial costs (profit).

Patient eligibility is based on MTX concentrations and laboratory values obtained per standard of care. Once an Investigator identifies a potential patient, he/she will contact the Voraxaze central call center (1-877-398-9829) to receive information regarding drug shipment. Eligible patients will have routine demographic, MTX, and Voraxaze therapy information collected.

Each patient will receive a single dose of Voraxaze 50 Units/kg in a bolus intravenous injection over 5 minutes. In addition to Voraxaze, patients will continue to receive standard of care treatment including leucovorin therapy, and supportive care such as hydration, alkalinization of urine and, if necessary, hemoperfusion/dialysis.

Expanded Access
Drug: Voraxaze (glucarpidase)
50 Units/kg in a bolus intravenous injection over 5 minutes
Other Names:
  • carboxypeptidase
  • CPG2
  • CPDG2
Not Provided
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00481559
BTG International Inc.
BTG International Inc.
CTI Clinical Trial and Consulting Services
Study Chair: Paul Litka, MD BTG (contract)
BTG International Inc.
January 2014