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

Neoplasms Clinical Trial

Official title: An Open-Label Treatment Protocol for the Use of Voraxaze as Adjunctive Treatment for Patients Experiencing or at Risk of Methotrexate Toxicity

Status Approved for marketing

Clinical Trial Summary

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

Clinical Trial Description

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 Design

N/A

Related Conditions & MeSH terms

• Neoplasms

• NCT number: NCT00481559
• Study type: Expanded Access
• Source: BTG International Inc.
• Status: Approved for marketing
• Phase: N/A