A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title:

Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00282399
• Other study ID #: DACO-019
• Status: Terminated
• Phase: Phase 1
• First received: January 25, 2006
• Last updated: October 27, 2015
• Start date: October 2006
• Est. completion date: February 2009

Study information

• Verified date: October 2015
• 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 was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).

Description:

Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS

Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.

Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: February 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

2. Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

1. Prior therapy with decitabine or azacytidine (Vidaza).

2. Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.

3. Clinically significant anemia.

4. Prior history of malignancy other than MDS.

5. Any active infection.

6. Radiotherapy within 14 days prior to study enrollment.

Study Design

Allocation: 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:
• Subcutaneous Decitabine

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	H Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.		Up to 8 cycles (224 days)	No
Primary	Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.		Up to 12 cycles (336 days)	No

External Links

•   MGI PHARMA's official website