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

Myelodysplastic Syndrome Clinical Trial

Official title:

A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260065
• Other study ID #: DACO-020
• Status: Completed
• Phase: Phase 2
• First received: November 28, 2005
• Last updated: May 13, 2013
• Start date: May 2005
• Est. completion date: December 2008

Study information

• Verified date: June 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Must sign an Institutional Review Board (IRB) -approved informed consent form.

2. Must be 18 years of age or older.

3. 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.

4. If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.

5. If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.

Exclusion Criteria:

1. Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.

2. Must not have received any investigational agent within the 30 days preceding the first dose of study drug.

3. Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.

4. Must not have an active viral or bacterial infection.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	1 year	No
Secondary	Best Response and Overall Improvement	Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)	1 year	No

External Links

•   MGI Pharma's website