At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Decitabine (Dacogen)drug
Likely dose
Decitabine (Dacogen) 135 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
In Brief
A Phase 1 clinical trial evaluating Decitabine (Dacogen) for Leukemia. Completed, enrolled 16 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2005
Primary CompletionJan 2006
Study CompletionJun 2007
First PostedJun 2011
TodayJul 2026
First PostedJun 22, 2011
Enrollment StartApr 1, 2005
Primary CompletionJan 1, 2006
Study CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.0 years ago
Interventions
Decitabine (Dacogen)drug
Intravenous injection; total dose-per-cycle was 135 mg/m\^2 of decitabine.