Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity
|ClinicalTrials.gov Identifier: NCT00481559|
Recruitment Status : Approved for marketing
First Posted : June 1, 2007
Last Update Posted : January 17, 2014
|Condition or disease||Intervention/treatment|
|Neoplasms||Drug: Voraxaze (glucarpidase)|
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.
|Study Type :||Expanded Access|
|Official Title:||An Open-Label Treatment Protocol for the Use of Voraxaze as Adjunctive Treatment for Patients Experiencing or at Risk of Methotrexate Toxicity|
Drug: Voraxaze (glucarpidase)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481559
|Study Chair:||Paul Litka, MD||BTG (contract)|