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Voraxaze for Delayed Methotrexate Clearance

NCT00424645 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2012-12-06

Study results available
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Summary

Primary Objectives:

1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of methotrexate (MTX) clearance following high dose MTX treatment in patients with a delayed MTX clearance.
2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance.
3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance.

Secondary Objectives:

1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics.
2. To evaluate the effect of Glucarpidase on the length of hospitalization.
3. To evaluate the effect of Glucarpidase on renal function.
4. To evaluate the effect of Glucarpidase on Quality of Life (QOL).
5. To evaluate the anti-glucarpidase antibody response.
6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment.

Conditions

Interventions

DRUG

Voraxaze (Glucarpidase)

50 units/kg IV within 12 hours of study eligibility being confirmed.

DRUG

Placebo

Administered by IV within 12 hours of study eligibility being confirmed.

Sponsors & Collaborators

  • BTG International Inc.

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Saroj Vadhan-Raj, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00424645 on ClinicalTrials.gov