A Study of Decitabine Given to Adults With Advanced-Stage... | NCT00260065

NCT00260065

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: Decitabine

Name	Type	Description	Arm Group Labels	Other Names
Decitabine	Drug	20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Achieved Overall Response	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)	1 year

Secondary Outcomes

Measure	Description	Time Frame
Best Response and Overall Improvement	Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)	1 year

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Eisai US Medical Services	Eisai Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35235	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23790798	Derived	Jabbour E, Kantarjian H, O'Brien S, Kadia T, Malik A, Welch MA, Teng A, Cortes J, Ravandi F, Garcia-Manero G. Retrospective analysis of prognostic factors associated with response and overall survival by baseline marrow blast percentage in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):592-6. doi: 10.1016/j.clml.2013.05.004. Epub 2013 Jun 20.
23260600

Label	URL
MGI Pharma's website	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Decitabine 20 mg/m2 Intravenous	Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

ID	Title	Description
BG000	Decitabine 20 mg/m2 Intravenous	Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.

Units	Counts
Participants	BG00099

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG00015
>=65 years	BG000

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00070.9± 8.78

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00028
Male	BG00071

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0004

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00099

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Achieved Overall Response

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)

Intent-to-treat (ITT)

Posted

Number

participants

1 year

ID	Title	Description
OG000	Decitabine 20 mg/m2 Intravenous	Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.

Units	Counts
Participants	OG00099

Title

Denominators

Categories

Title	Measurements
	OG00033

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000						Percentage of Participants	33				95	24.2	43.5				No	Superiority or Other

Secondary

Best Response and Overall Improvement

Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)

Intent-to-treat (ITT)

Posted

Number

Participants

1 year

ID	Title	Description
OG000	Decitabine 20 mg/m2 Intravenous	Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.

Units	Counts
Participants	OG00099

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Decitabine 20 mg/m2 Intravenous	Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.			65	99	96	99

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0009 affected99 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG00013 affected99 at risk
Neutropenia	Blood and lymphatic system disorders	EG00012 affected99 at risk
Pancytopenia	Blood and lymphatic system disorders	EG0004 affected99 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0003 affected99 at risk
Cardiac Failure Congestive	Cardiac disorders	EG0002 affected99 at risk
Myocardial Infarction	Cardiac disorders	EG0002 affected99 at risk
Stomatitis	Gastrointestinal disorders	EG0002 affected99 at risk
Asthenia	General disorders	EG0002 affected99 at risk
Disease Progression	General disorders	EG0004 affected99 at risk
Pyrexia	General disorders	EG0006 affected99 at risk
Cellulitis	Infections and infestations	EG0002 affected99 at risk
Clostridial Infection	Infections and infestations	EG0003 affected99 at risk
Lung Infection	Infections and infestations	EG0002 affected99 at risk
Pneumonia	Infections and infestations	EG00017 affected99 at risk
Sepsis	Infections and infestations	EG0004 affected99 at risk
Septic Shock	Infections and infestations	EG0002 affected99 at risk
Staphylococcal Bacteraemia	Infections and infestations	EG0007 affected99 at risk
Staphylococcal Sepsis	Infections and infestations	EG0002 affected99 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG0002 affected99 at risk
Dehydration	Metabolism and nutrition disorders	EG0002 affected99 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0004 affected99 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0002 affected99 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG00031 affected99 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG00020 affected99 at risk
Leukopenia	Blood and lymphatic system disorders	EG0006 affected99 at risk
Neutropenia	Blood and lymphatic system disorders	EG00038 affected99 at risk
Pancytopenia	Blood and lymphatic system disorders	EG0005 affected99 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG00027 affected99 at risk
Thrombocythaemia	Blood and lymphatic system disorders	EG0005 affected99 at risk
Cardiac Failure Congestive	Cardiac disorders	EG0005 affected99 at risk
Tachycardia	Cardiac disorders	EG0008 affected99 at risk
Ear Pain	Ear and labyrinth disorders	EG0006 affected99 at risk
Abdominal Pain	Gastrointestinal disorders	EG00014 affected99 at risk
Abdominal Pain Upper	Gastrointestinal disorders	EG0006 affected99 at risk
Constipation	Gastrointestinal disorders	EG00030 affected99 at risk
Diarrhea	Gastrointestinal disorders	EG00028 affected99 at risk
Dyspepsia	Gastrointestinal disorders	EG00010 affected99 at risk
Dysphagia	Gastrointestinal disorders	EG0005 affected99 at risk
Gastroesophageal Reflux Disease	Gastrointestinal disorders	EG0005 affected99 at risk
Nausea	Gastrointestinal disorders	EG00040 affected99 at risk
Oral Pain	Gastrointestinal disorders	EG0005 affected99 at risk
Stomatitis	Gastrointestinal disorders	EG00011 affected99 at risk
Toothache	Gastrointestinal disorders	EG0006 affected99 at risk
Vomiting	Gastrointestinal disorders	EG00016 affected99 at risk
Asthenia	General disorders	EG00015 affected99 at risk
Chest Pain	General disorders	EG0006 affected99 at risk
Chills	General disorders	EG00016 affected99 at risk
Fatigue	General disorders	EG00046 affected99 at risk
Mucosal Inflammation	General disorders	EG0009 affected99 at risk
Oedema	General disorders	EG0005 affected99 at risk
Oedema Peripheral	General disorders	EG00027 affected99 at risk
Pain	General disorders	EG0005 affected99 at risk
Pyrexia	General disorders	EG00036 affected99 at risk
Cellulitis	Infections and infestations	EG0009 affected99 at risk
Oral Candidiasis	Infections and infestations	EG0006 affected99 at risk
Pneumonia	Infections and infestations	EG00020 affected99 at risk
Sinusitis	Infections and infestations	EG0006 affected99 at risk
Staphylococcal Bacteraemia	Infections and infestations	EG0008 affected99 at risk
Tooth Abscess	Infections and infestations	EG0005 affected99 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG00010 affected99 at risk
Urinary Tract Infection	Infections and infestations	EG0007 affected99 at risk
Contusion	Injury, poisoning and procedural complications	EG0009 affected99 at risk
Blood Bilirubin Increased	Investigations	EG0006 affected99 at risk
Breath Sounds Abnormal	Investigations	EG0005 affected99 at risk
Weight Decreased	Investigations	EG0009 affected99 at risk
Anorexia	Metabolism and nutrition disorders	EG00023 affected99 at risk
Decreased Appetite	Metabolism and nutrition disorders	EG0008 affected99 at risk
Dehydration	Metabolism and nutrition disorders	EG0008 affected99 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0006 affected99 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG00012 affected99 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	EG0005 affected99 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG00017 affected99 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG00018 affected99 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	EG0006 affected99 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	EG0007 affected99 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	EG0005 affected99 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG0005 affected99 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0009 affected99 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG00018 affected99 at risk
Anxiety	Psychiatric disorders	EG0009 affected99 at risk
Confusional State	Psychiatric disorders	EG0008 affected99 at risk
Depression	Psychiatric disorders	EG0009 affected99 at risk
Insomnia	Psychiatric disorders	EG00014 affected99 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00027 affected99 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG00029 affected99 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG00013 affected99 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	EG0008 affected99 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0005 affected99 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	EG0005 affected99 at risk
Dry Skin	Skin and subcutaneous tissue disorders	EG0008 affected99 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	EG0009 affected99 at risk
Erythema	Skin and subcutaneous tissue disorders	EG0005 affected99 at risk
Night Sweats	Skin and subcutaneous tissue disorders	EG0005 affected99 at risk
Petechiae	Skin and subcutaneous tissue disorders	EG00012 affected99 at risk
Pruritis	Skin and subcutaneous tissue disorders	EG0009 affected99 at risk
Rash	Skin and subcutaneous tissue disorders	EG00011 affected99 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	EG0005 affected99 at risk
Hypertension	Vascular disorders	EG0006 affected99 at risk
Hypotension	Vascular disorders	EG00011 affected99 at risk
Dizziness	Nervous system disorders	EG00021 affected99 at risk
Headache	Nervous system disorders	EG00023 affected99 at risk

ID	Term
D009190	Myelodysplastic Syndromes

ID	Term
D000077209	Decitabine

Ancestor Terms

ID	Term
D001374	Azacitidine
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases