Trial Outcomes & Findings for A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes (NCT NCT00260065)
NCT ID: NCT00260065
Last Updated: 2013-05-20
Results Overview
Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
1 year
Results posted on
2013-05-20
Participant Flow
Participant milestones
| Measure |
Decitabine 20 mg/m2 Intravenous
Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
99
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
93
|
Reasons for withdrawal
| Measure |
Decitabine 20 mg/m2 Intravenous
Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
|
|---|---|
|
Overall Study
Progressive Disease
|
22
|
|
Overall Study
Adverse Event
|
17
|
|
Overall Study
Death
|
13
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Physician Decision
|
19
|
|
Overall Study
Not otherwise specified
|
8
|
|
Overall Study
Medication Noncompliance
|
1
|
Baseline Characteristics
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Decitabine 20 mg/m2 Intravenous
n=99 Participants
Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
84 Participants
n=5 Participants
|
|
Age Continuous
|
70.9 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat (ITT)
Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)
Outcome measures
| Measure |
Decitabine 20 mg/m2 Intravenous
n=99 Participants
Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
|
|---|---|
|
Number of Participants Who Achieved Overall Response
|
33 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat (ITT)
Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)
Outcome measures
| Measure |
Decitabine 20 mg/m2 Intravenous
n=99 Participants
Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
|
|---|---|
|
Best Response and Overall Improvement
Overall Improvement
|
51 Participants
|
|
Best Response and Overall Improvement
Complete Remission (CR)
|
17 Participants
|
|
Best Response and Overall Improvement
Marrow Complete Remission (mCR)
|
16 Participants
|
|
Best Response and Overall Improvement
Partial Remission (PR)
|
0 Participants
|
|
Best Response and Overall Improvement
Hematologic Improvement (HI)
|
18 Participants
|
Adverse Events
Decitabine 20 mg/m2 Intravenous
Serious events: 65 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decitabine 20 mg/m2 Intravenous
n=99 participants at risk
Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
9/99
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
13.1%
13/99
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.1%
12/99
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.0%
4/99
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
3/99
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.0%
2/99
|
|
Cardiac disorders
Myocardial Infarction
|
2.0%
2/99
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
2/99
|
|
General disorders
Asthenia
|
2.0%
2/99
|
|
General disorders
Disease Progression
|
4.0%
4/99
|
|
General disorders
Pyrexia
|
6.1%
6/99
|
|
Infections and infestations
Cellulitis
|
2.0%
2/99
|
|
Infections and infestations
Clostridial Infection
|
3.0%
3/99
|
|
Infections and infestations
Lung Infection
|
2.0%
2/99
|
|
Infections and infestations
Pneumonia
|
17.2%
17/99
|
|
Infections and infestations
Sepsis
|
4.0%
4/99
|
|
Infections and infestations
Septic Shock
|
2.0%
2/99
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
7.1%
7/99
|
|
Infections and infestations
Staphylococcal Sepsis
|
2.0%
2/99
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.0%
2/99
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
2/99
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
4/99
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.0%
2/99
|
Other adverse events
| Measure |
Decitabine 20 mg/m2 Intravenous
n=99 participants at risk
Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.3%
31/99
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
20.2%
20/99
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.1%
6/99
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.4%
38/99
|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.1%
5/99
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.3%
27/99
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
5.1%
5/99
|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.1%
5/99
|
|
Cardiac disorders
Tachycardia
|
8.1%
8/99
|
|
Ear and labyrinth disorders
Ear Pain
|
6.1%
6/99
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.1%
14/99
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.1%
6/99
|
|
Gastrointestinal disorders
Constipation
|
30.3%
30/99
|
|
Gastrointestinal disorders
Diarrhea
|
28.3%
28/99
|
|
Gastrointestinal disorders
Dyspepsia
|
10.1%
10/99
|
|
Gastrointestinal disorders
Dysphagia
|
5.1%
5/99
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
5.1%
5/99
|
|
Gastrointestinal disorders
Nausea
|
40.4%
40/99
|
|
Gastrointestinal disorders
Oral Pain
|
5.1%
5/99
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
11/99
|
|
Gastrointestinal disorders
Toothache
|
6.1%
6/99
|
|
Gastrointestinal disorders
Vomiting
|
16.2%
16/99
|
|
General disorders
Asthenia
|
15.2%
15/99
|
|
General disorders
Chest Pain
|
6.1%
6/99
|
|
General disorders
Chills
|
16.2%
16/99
|
|
General disorders
Fatigue
|
46.5%
46/99
|
|
General disorders
Mucosal Inflammation
|
9.1%
9/99
|
|
General disorders
Oedema
|
5.1%
5/99
|
|
General disorders
Oedema Peripheral
|
27.3%
27/99
|
|
General disorders
Pain
|
5.1%
5/99
|
|
General disorders
Pyrexia
|
36.4%
36/99
|
|
Infections and infestations
Cellulitis
|
9.1%
9/99
|
|
Infections and infestations
Oral Candidiasis
|
6.1%
6/99
|
|
Infections and infestations
Pneumonia
|
20.2%
20/99
|
|
Infections and infestations
Sinusitis
|
6.1%
6/99
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
8.1%
8/99
|
|
Infections and infestations
Tooth Abscess
|
5.1%
5/99
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.1%
10/99
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
7/99
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
9/99
|
|
Investigations
Blood Bilirubin Increased
|
6.1%
6/99
|
|
Investigations
Breath Sounds Abnormal
|
5.1%
5/99
|
|
Investigations
Weight Decreased
|
9.1%
9/99
|
|
Metabolism and nutrition disorders
Anorexia
|
23.2%
23/99
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.1%
8/99
|
|
Metabolism and nutrition disorders
Dehydration
|
8.1%
8/99
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
6/99
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.1%
12/99
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.1%
5/99
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.2%
17/99
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
18.2%
18/99
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.1%
6/99
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.1%
7/99
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.1%
5/99
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.1%
5/99
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
9/99
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
18.2%
18/99
|
|
Psychiatric disorders
Anxiety
|
9.1%
9/99
|
|
Psychiatric disorders
Confusional State
|
8.1%
8/99
|
|
Psychiatric disorders
Depression
|
9.1%
9/99
|
|
Psychiatric disorders
Insomnia
|
14.1%
14/99
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
27/99
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.3%
29/99
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.1%
13/99
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
8.1%
8/99
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.1%
5/99
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
5.1%
5/99
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.1%
8/99
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.1%
9/99
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.1%
5/99
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
5.1%
5/99
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
12.1%
12/99
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.1%
9/99
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
11/99
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.1%
5/99
|
|
Vascular disorders
Hypertension
|
6.1%
6/99
|
|
Vascular disorders
Hypotension
|
11.1%
11/99
|
|
Nervous system disorders
Dizziness
|
21.2%
21/99
|
|
Nervous system disorders
Headache
|
23.2%
23/99
|
Additional Information
Eisai Call Center
Eisai Inc.
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place