A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282399

Enrollment

Registered

2006-01-26

Start date

2006-10-31

Completion date

2009-02-28

Last updated

2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome, MGI Pharma, Decitabine, Dacogen

Brief summary

The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).

Detailed 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

Interventions

DRUGSubcutaneous Decitabine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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)
Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.	Up to 12 cycles (336 days)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026