Trial Outcomes & Findings for Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome (NCT NCT01378416)
NCT ID: NCT01378416
Last Updated: 2011-07-12
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Day 1, Day 2, Day 3
Results posted on
2011-07-12
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Decitabine
n=16 Participants
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.
|
|---|---|
|
Age Continuous
|
68.2 years
STANDARD_DEVIATION 11.12 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Day 33-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).
Outcome measures
| Measure |
Decitabine
n=16 Participants
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.
|
|---|---|
|
Average Total Body Clearance (Calculated From Rate and Concentration)
|
129 L/hr/m^2
48.6
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Day 33-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).
Outcome measures
| Measure |
Decitabine
n=16 Participants
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.
|
|---|---|
|
Cmax (Maximum Plasma Concentration)
Day 1
|
73.8 ng/mL
Standard Deviation 48.6 • Interval 62.1 to 66.0
|
|
Cmax (Maximum Plasma Concentration)
Day 2
|
64.8 ng/mL
Standard Deviation 40.2 • Interval 54.5 to 62.0
|
|
Cmax (Maximum Plasma Concentration)
Day 3
|
77.0 ng/mL
Standard Deviation 62.5 • Interval 60.3 to 81.0
|
PRIMARY outcome
Timeframe: Day 1, Day 2, Day 33-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).
Outcome measures
| Measure |
Decitabine
n=16 Participants
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.
|
|---|---|
|
Tmax (Time at Which Cmax First Observed)
Day 1
|
2.49 hours
Standard Deviation 0.70
|
|
Tmax (Time at Which Cmax First Observed)
Day 2
|
2.53 hours
Standard Deviation 0.69
|
|
Tmax (Time at Which Cmax First Observed)
Day 3
|
2.29 hours
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: Day 1, Day 2, day 33-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).
Outcome measures
| Measure |
Decitabine
n=16 Participants
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.
|
|---|---|
|
AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Day 1
|
163 ng∙hr/mL
Standard Deviation 101
|
|
AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Day 2
|
152 ng∙hr/mL
Standard Deviation 90.5
|
|
AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Day 3
|
158 ng∙hr/mL
Standard Deviation 101
|
SECONDARY outcome
Timeframe: 6 weeksSummary of All Adverse Events (AEs) by Maximum Grade Occurring in \>= 10% Patients
Outcome measures
| Measure |
Decitabine
n=16 Participants
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.
|
|---|---|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Musculoskeletal and Connective Tissue Disorders
|
6 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Nervous System Disorders
|
8 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Psychiatric Disorders
|
5 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Blood & Lymphatic System Disorders
|
4 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Cardiac Disorders
|
2 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Eye Disorders
|
2 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Gastrointestinal Disorders
|
11 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
General Disorders & Administration Site Conditions
|
14 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Infections and Infestations
|
7 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Investigations - Weight decreased
|
2 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Metabolism and Nutrition
|
5 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Respiratory, Thoracic and Mediastinal Disorders
|
13 Participants
|
|
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Skin and Subcutaneous Tissue Disorders
|
9 Participants
|
Adverse Events
Decitabine
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decitabine
n=16 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
18.8%
3/16
|
|
General disorders
Chills
|
12.5%
2/16
|
|
General disorders
Disease Progression
|
6.2%
1/16
|
|
General disorders
Pyrexia
|
6.2%
1/16
|
|
Infections and infestations
Bacteraemia
|
6.2%
1/16
|
|
Infections and infestations
Cellulitis
|
6.2%
1/16
|
|
Infections and infestations
Diverticulitis
|
6.2%
1/16
|
|
Infections and infestations
Pneumonia
|
12.5%
2/16
|
|
Infections and infestations
Sepsis
|
12.5%
2/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia Recurrent
|
6.2%
1/16
|
|
Nervous system disorders
Cerebral Ischemia
|
6.2%
1/16
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
6.2%
1/16
|
Other adverse events
| Measure |
Decitabine
n=16 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Palpitations
|
6.2%
1/16
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
1/16
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.2%
1/16
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16
|
|
Eye disorders
Visual Accuity Reduced
|
6.2%
1/16
|
|
Eye disorders
Visual Disturbance
|
6.2%
1/16
|
|
Gastrointestinal disorders
Abdominal Distention
|
6.2%
1/16
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16
|
|
Gastrointestinal disorders
Gingival Bleeding
|
12.5%
2/16
|
|
Gastrointestinal disorders
Loose Tooth
|
6.2%
1/16
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16
|
|
Gastrointestinal disorders
Proctalgia
|
6.2%
1/16
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
6.2%
1/16
|
|
Gastrointestinal disorders
Tongue Ulceration
|
12.5%
2/16
|
|
Gastrointestinal disorders
Toothache
|
12.5%
2/16
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
|
|
General disorders
Asthenia
|
12.5%
2/16
|
|
General disorders
Catheter Site Erythema
|
6.2%
1/16
|
|
General disorders
Catheter Site Haematoma
|
6.2%
1/16
|
|
General disorders
Catheter Site Related Reaction
|
6.2%
1/16
|
|
General disorders
Chest Discomfort
|
6.2%
1/16
|
|
General disorders
Chest Pain
|
12.5%
2/16
|
|
General disorders
Chills
|
25.0%
4/16
|
|
General disorders
Fatigue
|
37.5%
6/16
|
|
General disorders
Feeling Hot
|
6.2%
1/16
|
|
General disorders
Implant Site Bruising
|
6.2%
1/16
|
|
General disorders
Implant Site Pain
|
6.2%
1/16
|
|
General disorders
Oedema
|
6.2%
1/16
|
|
General disorders
Pyrexia
|
25.0%
4/16
|
|
General disorders
Thirst
|
6.2%
1/16
|
|
Immune system disorders
Graft Versus Host Disease in Liver
|
6.2%
1/16
|
|
Infections and infestations
Bacteraemia
|
6.2%
1/16
|
|
Infections and infestations
Candidiasis
|
6.2%
1/16
|
|
Infections and infestations
Cellulitis
|
6.2%
1/16
|
|
Infections and infestations
Diverticulitis
|
6.2%
1/16
|
|
Infections and infestations
Implant Site Cellulitis
|
6.2%
1/16
|
|
Infections and infestations
Pneumonia
|
18.8%
3/16
|
|
Investigations
Weight Decreased
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
3/16
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
2/16
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
18.8%
3/16
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
12.5%
2/16
|
|
Nervous system disorders
Cerebral Ischaemia
|
6.2%
1/16
|
|
Nervous system disorders
Dizziness
|
25.0%
4/16
|
|
Nervous system disorders
Dysgeusia
|
12.5%
2/16
|
|
Nervous system disorders
Headache
|
12.5%
2/16
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
1/16
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
6.2%
1/16
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16
|
|
Psychiatric disorders
Anxiety
|
25.0%
4/16
|
|
Psychiatric disorders
Depression
|
6.2%
1/16
|
|
Renal and urinary disorders
Polyuria
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
6/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
37.5%
6/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
12.5%
2/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
12.5%
2/16
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
12.5%
2/16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Blood Blister
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Increased Tendency to Bruise
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Night Sweats
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin Nodule
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
1/16
|
Additional Information
Yufang Lu, MD PhD
Eisai Inc.
Phone: 1-888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place