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NCT00360438 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT00360438: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00360438 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00360438, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

Primary 1\. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS) Secondary 1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first rasburicase treatment) through 48 hours after the last per-protocol planned administration of rasburicase treatment; 2. To evaluate the safety of rasburicase in adult patients with leukemia and/or lymphoma. 3. To evaluate incidence, duration, and type of immune responses (IgG, IgE, and neutralizing antibody) to rasburicase.

Interventions

  • DRUG Rasburicase

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2006-07
Est. Completion 2007-04
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT00360438

The ClinicalTrials.gov registry entry for NCT00360438 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 1 intervention - of which Rasburicase is the first listed.

NCT00360438 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00360438 about?

NCT00360438 is a clinical study titled "Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS". Primary 1\. To determine the pharmacokinetic (PK) parameters of rasburicase in adult patients with leukemia and/or lymphoma at high risk or potential risk of tumor lysis syndrome (TLS) Secondary 1. To evaluate plasma uric acid AUC from baseline (within 4 hours prior to first rasburicase treatment...

What is the current status of trial NCT00360438?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2006-07. Estimated completion is 2007-04.

What interventions are being tested in trial NCT00360438?

The interventions under investigation include: Rasburicase (DRUG).

Who is sponsoring clinical trial NCT00360438?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.