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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome

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Trial Information

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


Phase I: The purpose of this study is 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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Authority:

United States: Food and Drug Administration

Study ID:

DACO-019

NCT ID:

NCT00282399

Start Date:

October 2006

Completion Date:

February 2009

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • MGI Pharma
  • Decitabine
  • Dacogen
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Albert Einstein College of MedicineBronx, New York  10461
University of Arizona Cancer CenterTucson, Arizona  85724
H Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612