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NCT00634504 · ClinicalTrials.gov registry record · Phase 1

Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze

A Phase 1 study, sponsored by BTG International.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT00634504 is a Phase 1 study that has completed, run by BTG International. The registered enrollment target is 20 participants.

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The verdict

NCT00634504, a Phase 1 study, has completed, sponsored by BTG International.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.

Interventions

  • DRUG glucarpidase, high-dose methotrexate, leucovorin
  • DRUG high-dose methotrexate, leucovorin

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2008-05
Est. Completion 2009-08
Phase Phase 1

Sponsor

BTG International

5 total trials

What the Registry Record Tells You About NCT00634504

The ClinicalTrials.gov registry entry for NCT00634504 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BTG International, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which glucarpidase, high-dose methotrexate, leucovorin is the first listed.

NCT00634504 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00634504 about?

NCT00634504 is a clinical study titled "Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze". The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.

What is the current status of trial NCT00634504?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2008-05. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00634504?

The interventions under investigation include: glucarpidase, high-dose methotrexate, leucovorin (DRUG), high-dose methotrexate, leucovorin (DRUG).

Who is sponsoring clinical trial NCT00634504?

This trial is sponsored by BTG International, which has 5 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, or report a data error.