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NCT01378416 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

A Phase 1 study, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT01378416 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 16 participants.

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The verdict

NCT01378416, a Phase 1 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

The purpose of this study is to determine the pharmacokinetics (PK) of decitabine administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Interventions

  • DRUG Decitabine (Dacogen)

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2005-04
Est. Completion 2007-06
Phase Phase 1

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT01378416

The ClinicalTrials.gov registry entry for NCT01378416 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Decitabine (Dacogen) is the first listed.

NCT01378416 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01378416 about?

NCT01378416 is a clinical study titled "Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome". The purpose of this study is to determine the pharmacokinetics (PK) of decitabine administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

What is the current status of trial NCT01378416?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2005-04. Estimated completion is 2007-06.

What interventions are being tested in trial NCT01378416?

The interventions under investigation include: Decitabine (Dacogen) (DRUG).

Who is sponsoring clinical trial NCT01378416?

This trial is sponsored by Eisai, which has 287 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.