Trial Outcomes & Findings for Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome (NCT NCT00760084)
NCT ID: NCT00760084
Last Updated: 2011-08-08
Results Overview
Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m\^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (\< 30% blasts) or AML (\> 30% blasts).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
3 months
Results posted on
2011-08-08
Participant Flow
Participant milestones
| Measure |
Decitabine
Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Decitabine
Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
|
|---|---|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Progressive Disease
|
3
|
Baseline Characteristics
Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Decitabine
n=10 Participants
Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
|
|---|---|
|
Age Continuous
|
68.5 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsGenerate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m\^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (\< 30% blasts) or AML (\> 30% blasts).
Outcome measures
| Measure |
Decitabine
n=10 Participants
Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
|
|---|---|
|
The Number of Subjects With Adverse Events
|
10 participants
|
Adverse Events
Decitabine
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decitabine
n=10 participants at risk
Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10
|
|
Cardiac disorders
Cardiac Failure Congestive
|
10.0%
1/10
|
|
Infections and infestations
Cellulitis Gangrenous
|
10.0%
1/10
|
|
Infections and infestations
Clostridium Difficile Colitis
|
10.0%
1/10
|
|
Infections and infestations
Pneumonia Primary Atypical
|
10.0%
1/10
|
|
Infections and infestations
Pseudomonal Bacteremia
|
10.0%
1/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
10.0%
1/10
|
|
Nervous system disorders
Hemorrhage Intracranial
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10
|
Other adverse events
| Measure |
Decitabine
n=10 participants at risk
Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Splenomegaly
|
10.0%
1/10
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10
|
|
Eye disorders
Ocular Hyperaemia
|
20.0%
2/10
|
|
Eye disorders
Vision Blurred
|
10.0%
1/10
|
|
Eye disorders
Xerophthalmia
|
10.0%
1/10
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
2/10
|
|
Gastrointestinal disorders
Upper Abdominal Pain
|
10.0%
1/10
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
10.0%
1/10
|
|
Gastrointestinal disorders
Gingival Bleeding
|
20.0%
2/10
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
1/10
|
|
Gastrointestinal disorders
Mouth Hemorrhage
|
10.0%
1/10
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10
|
|
Gastrointestinal disorders
Stomach Discomfort
|
10.0%
1/10
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10
|
|
General disorders
Chest Discomfort
|
10.0%
1/10
|
|
General disorders
Chest Pain
|
20.0%
2/10
|
|
General disorders
Chills
|
10.0%
1/10
|
|
General disorders
Fatigue
|
80.0%
8/10
|
|
General disorders
Injection Site Reaction
|
10.0%
1/10
|
|
General disorders
Oedema
|
10.0%
1/10
|
|
General disorders
Oedema Peripheral
|
10.0%
1/10
|
|
General disorders
Pain
|
20.0%
2/10
|
|
General disorders
Pyrexia
|
30.0%
3/10
|
|
Hepatobiliary disorders
Hepatitis
|
10.0%
1/10
|
|
Infections and infestations
Perirectal Abscess
|
10.0%
1/10
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Transfusion Reaction
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Wound
|
10.0%
1/10
|
|
Investigations
Blood Uric Acid Increased
|
10.0%
1/10
|
|
Investigations
Weight Decreased
|
20.0%
2/10
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Iron Overload
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
30.0%
3/10
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
20.0%
2/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
30.0%
3/10
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
10.0%
1/10
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10
|
|
Nervous system disorders
Headache
|
20.0%
2/10
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
1/10
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
4/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.0%
3/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
30.0%
3/10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Respiratiory Tract Infection
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
20.0%
2/10
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Periorbital Oedema
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
20.0%
2/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Rash Generalized
|
10.0%
1/10
|
|
Vascular disorders
Hot Flush
|
10.0%
1/10
|
Additional Information
Yufang Lu, MD, PhD
Eisai Inc.
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place