Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378416
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : June 22, 2011
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Eisai Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Intervention Drug: Decitabine (Dacogen)
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Decitabine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Decitabine
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
68.2  (11.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
4
  25.0%
Male
12
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Average Total Body Clearance (Calculated From Rate and Concentration)
Hide Description 3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
Time Frame Day 1, Day 2, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decitabine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: L/hr/m^2
129
2.Primary Outcome
Title Cmax (Maximum Plasma Concentration)
Hide Description 3-hour IV infusion, every 8 hours for three consecutive days. Cmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
Time Frame Day 1, Day 2, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decitabine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 73.8  (48.6)
Day 2 64.8  (40.2)
Day 3 77.0  (62.5)
3.Primary Outcome
Title Tmax (Time at Which Cmax First Observed)
Hide Description 3-hour IV infusion, every 8 hours for three consecutive days. Tmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
Time Frame Day 1, Day 2, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decitabine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: hours
Day 1 2.49  (0.70)
Day 2 2.53  (0.69)
Day 3 2.29  (0.63)
4.Primary Outcome
Title AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Hide Description 3-hour IV infusion, every 8 hours for three consecutive days. AUC (0-∞) was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
Time Frame Day 1, Day 2, day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decitabine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: ng∙hr/mL
Day 1 163  (101)
Day 2 152  (90.5)
Day 3 158  (101)
5.Secondary Outcome
Title Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Hide Description Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decitabine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Participants
Blood & Lymphatic System Disorders 4
Cardiac Disorders 2
Eye Disorders 2
Gastrointestinal Disorders 11
General Disorders & Administration Site Conditions 14
Infections and Infestations 7
Investigations - Weight decreased 2
Metabolism and Nutrition 5
Musculoskeletal and Connective Tissue Disorders 6
Nervous System Disorders 8
Psychiatric Disorders 5
Respiratory, Thoracic and Mediastinal Disorders 13
Skin and Subcutaneous Tissue Disorders 9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Decitabine
Hide Arm/Group Description 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.
All-Cause Mortality
Decitabine
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Decitabine
Affected / at Risk (%)
Total   9/16 (56.25%) 
Blood and lymphatic system disorders   
Febrile Neutropenia  3/16 (18.75%) 
General disorders   
Chills  2/16 (12.50%) 
Disease Progression  1/16 (6.25%) 
Pyrexia  1/16 (6.25%) 
Infections and infestations   
Bacteraemia  1/16 (6.25%) 
Cellulitis  1/16 (6.25%) 
Diverticulitis  1/16 (6.25%) 
Pneumonia  2/16 (12.50%) 
Sepsis  2/16 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute Myeloid Leukemia Recurrent  1/16 (6.25%) 
Nervous system disorders   
Cerebral Ischemia  1/16 (6.25%) 
Peripheral Sensory Neuropathy  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1/16 (6.25%) 
Epistaxis  1/16 (6.25%) 
Lung Infiltration  1/16 (6.25%) 
Pleural Effusion  1/16 (6.25%) 
Skin and subcutaneous tissue disorders   
Skin Necrosis  1/16 (6.25%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Decitabine
Affected / at Risk (%)
Total   16/16 (100.00%) 
Blood and lymphatic system disorders   
Febrile Neutropenia  1/16 (6.25%) 
Cardiac disorders   
Palpitations  1/16 (6.25%) 
Atrial Fibrillation  1/16 (6.25%) 
Ear and labyrinth disorders   
Vertigo  1/16 (6.25%) 
Eye disorders   
Visual Accuity Reduced  1/16 (6.25%) 
Visual Disturbance  1/16 (6.25%) 
Gastrointestinal disorders   
Abdominal Distention  1/16 (6.25%) 
Constipation  5/16 (31.25%) 
Diarrhoea  2/16 (12.50%) 
Gingival Bleeding  2/16 (12.50%) 
Loose Tooth  1/16 (6.25%) 
Nausea  7/16 (43.75%) 
Proctalgia  1/16 (6.25%) 
Rectal Hemorrhage  1/16 (6.25%) 
Tongue Ulceration  2/16 (12.50%) 
Toothache  2/16 (12.50%) 
Vomiting  1/16 (6.25%) 
General disorders   
Asthenia  2/16 (12.50%) 
Catheter Site Erythema  1/16 (6.25%) 
Catheter Site Haematoma  1/16 (6.25%) 
Catheter Site Related Reaction  1/16 (6.25%) 
Chest Discomfort  1/16 (6.25%) 
Chest Pain  2/16 (12.50%) 
Chills  4/16 (25.00%) 
Fatigue  6/16 (37.50%) 
Feeling Hot  1/16 (6.25%) 
Implant Site Bruising  1/16 (6.25%) 
Implant Site Pain  1/16 (6.25%) 
Oedema  1/16 (6.25%) 
Pyrexia  4/16 (25.00%) 
Thirst  1/16 (6.25%) 
Immune system disorders   
Graft Versus Host Disease in Liver  1/16 (6.25%) 
Infections and infestations   
Bacteraemia  1/16 (6.25%) 
Candidiasis  1/16 (6.25%) 
Cellulitis  1/16 (6.25%) 
Diverticulitis  1/16 (6.25%) 
Implant Site Cellulitis  1/16 (6.25%) 
Pneumonia  3/16 (18.75%) 
Investigations   
Weight Decreased  2/16 (12.50%) 
Metabolism and nutrition disorders   
Anorexia  3/16 (18.75%) 
Glucose Tolerance Impaired  1/16 (6.25%) 
Hypokalaemia  1/16 (6.25%) 
Hypomagnesaemia  2/16 (12.50%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  2/16 (12.50%) 
Back Pain  2/16 (12.50%) 
Muscle Spasms  1/16 (6.25%) 
Pain in Extremity  3/16 (18.75%) 
Shoulder Pain  2/16 (12.50%) 
Nervous system disorders   
Cerebral Ischaemia  1/16 (6.25%) 
Dizziness  4/16 (25.00%) 
Dysgeusia  2/16 (12.50%) 
Headache  2/16 (12.50%) 
Hypoaesthesia  1/16 (6.25%) 
Peripheral Sensory Neuropathy  1/16 (6.25%) 
Psychiatric disorders   
Agitation  1/16 (6.25%) 
Anxiety  4/16 (25.00%) 
Depression  1/16 (6.25%) 
Renal and urinary disorders   
Polyuria  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1/16 (6.25%) 
Cough  6/16 (37.50%) 
Dyspnoea  6/16 (37.50%) 
Dyspnoea Exertional  2/16 (12.50%) 
Epistaxis  1/16 (6.25%) 
Hemoptysis  2/16 (12.50%) 
Lung Infiltration  1/16 (6.25%) 
Nasal Congestion  1/16 (6.25%) 
Painful Respiration  1/16 (6.25%) 
Paranasal Sinus Hypersecretion  2/16 (12.50%) 
Pharyngeal Erythema  1/16 (6.25%) 
Pharyngolaryngeal Pain  1/16 (6.25%) 
Pleural Effusion  1/16 (6.25%) 
Rhinorrhoea  1/16 (6.25%) 
Night Sweats  1/16 (6.25%) 
Skin and subcutaneous tissue disorders   
Blood Blister  1/16 (6.25%) 
Drug Eruption  1/16 (6.25%) 
Increased Tendency to Bruise  1/16 (6.25%) 
Rash  1/16 (6.25%) 
Skin Necrosis  1/16 (6.25%) 
Skin Nodule  2/16 (12.50%) 
Urticaria  1/16 (6.25%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yufang Lu, MD PhD
Organization: Eisai Inc.
Phone: 1-888-422-4743
Layout table for additonal information
Responsible Party: Gerard Kennealey, MD, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT01378416    
Other Study ID Numbers: DACO-018
First Submitted: September 30, 2008
First Posted: June 22, 2011
Results First Submitted: September 30, 2008
Results First Posted: June 22, 2011
Last Update Posted: July 12, 2011