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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01378416
First received: September 30, 2008
Last updated: July 2, 2011
Last verified: July 2011
History of Changes
Results First Received: September 30, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: Decitabine (Dacogen)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Decitabine A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.

Participant Flow:   Overall Study
    Decitabine  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Decitabine A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.

Baseline Measures
    Decitabine  
Number of Participants  
[units: participants]
 		  16  
Age  
[units: years]
Mean ± Standard Deviation 		  68.2  ± 11.12  
Gender  
[units: participants]
 		 
Female     4  
Male     12  
Region of Enrollment  
[units: participants]
 		 
United States     16  



  Outcome Measures
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1.  Primary:   Average Total Body Clearance (Calculated From Rate and Concentration)   [ Time Frame: Day 1, Day 2, Day 3 ]
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2.  Primary:   Cmax (Maximum Plasma Concentration)   [ Time Frame: Day 1, Day 2, Day 3 ]
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3.  Primary:   Tmax (Time at Which Cmax First Observed)   [ Time Frame: Day 1, Day 2, Day 3 ]
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4.  Primary:   AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity   [ Time Frame: Day 1, Day 2, day 3 ]
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5.  Secondary:   Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)   [ Time Frame: 6 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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