Clinical trial · Expanded Access

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

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

NCT00481559CI-TRIAL-00013494approved for marketingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoplasms	Neoplasm	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Voraxaze (glucarpidase)	Drug	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

* Male or female patients of any age who are experiencing delayed MTX clearance due to impaired renal function will be eligible to receive Voraxaze if the have toxic plasma MTX concentrations (\>1 micromole per liter).

Exclusion Criteria:

* Voraxaze is not indicated for use in patients who exhibit the expected clearance of MTX (plasma MTX concentrations within 2 standard deviations of the mean MTX excretion curve specific for the dose of MTX administered) or those with normal or mildly impaired renal function because of the potential risk of sub therapeutic exposure to MTX.
* Patients with known hypersensitivity to Voraxaze (glucarpidase, carboxypeptidases)

Patients intolerant to lactose in food (e.g., dairy products) can still receive Voraxaze.

References

Publications (0)

Data not yet available

No reference posted for this study.