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NCT00424645 · ClinicalTrials.gov registry record · Phase 1
Voraxaze for Delayed Methotrexate Clearance
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00424645: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00424645 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00424645, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Voraxaze (Glucarpidase)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00424645
The ClinicalTrials.gov registry entry for NCT00424645 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00424645 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00424645 about?
NCT00424645 is a clinical study titled "Voraxaze for Delayed Methotrexate Clearance". 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...
What is the current status of trial NCT00424645?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2007-01. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00424645?
The interventions under investigation include: Placebo (DRUG), Voraxaze (Glucarpidase) (DRUG).
Who is sponsoring clinical trial NCT00424645?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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