A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes

NCT00260065 | Completed Phase 2 Results

• 1 other identifier: DACO-020
• Study Type: interventional
• Target: 99
• Locations: 2 countries
• Sites: 21

Brief Summary

The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome; Decitabine; Dacogen; MGI Pharma

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Best Response and Overall Improvement

  1 year

Study Arms (1)

1

EXPERIMENTAL

Drug: Decitabine

Interventions

Decitabine DRUG

20mg/m\^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.

Also known as: Dacogen

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must sign an Institutional Review Board (IRB) -approved informed consent form.
• Must be 18 years of age or older.
• Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
• If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
• If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.

You may not qualify if:

• Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
• Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
• Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
• Must not have an active viral or bacterial infection.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (21)

Unknown Facility

Birmingham, Alabama, 35235, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Boca Raton, Florida, 33486, United States

Location

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

New Port Richey, Florida, 34652, United States

Location

Unknown Facility

Griffin, Georgia, 30224, United States

Location

Unknown Facility

Chicago, Illinois, 60637-1470, United States

Location

Unknown Facility

Maywood, Illinois, 60153, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

Buffalo, New York, 14263, United States

Location

Unknown Facility

Canton, Ohio, 44718, United States

Location

Unknown Facility

Charleston, South Carolina, 29406, United States

Location

Unknown Facility

Memphis, Tennessee, 38138, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Midland, Texas, 79701, United States

Location

Unknown Facility

Seattle, Washington, 98104, United States

Location

Unknown Facility

La Crosse, Wisconsin, 54601, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53215, United States

Location

Unknown Facility

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (2)

• 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.

  PMID: 23790798 DERIVED

• Jabbour E, Garcia-Manero G, Ravandi F, Faderl S, O'Brien S, Fullmer A, Cortes JE, Wierda W, Kantarjian H. Prognostic factors associated with disease progression and overall survival in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):131-8. doi: 10.1016/j.clml.2012.11.001. Epub 2012 Dec 21.

  PMID: 23260600 DERIVED

Related Links

• MGI Pharma's website

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Eisai Call Center
• Organization: Eisai Inc.

888-422-4743

Study Officials

• Eisai US Medical Services

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: December 1, 2005
• Study Start: May 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 20, 2013
• Results First Posted: September 4, 2009

Record last verified: 2010-06

Locations

US (20); CA (1)