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Trials / Completed

CompletedNCT01378416

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Eisai Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGDecitabine (Dacogen)Intravenous injection; total dose-per-cycle was 135 mg/m\^2 of decitabine.

Timeline

Start date
2005-04-01
Primary completion
2006-01-01
Completion
2007-06-01
First posted
2011-06-22
Last updated
2011-07-12
Results posted
2011-06-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01378416. Inclusion in this directory is not an endorsement.

Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leuke (NCT01378416) · Clinical Trials Directory