Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
18 Years
N/A
Both
Myelodysplastic Syndrome
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 Medicine | Bronx, New York 10461 |
| University of Arizona Cancer Center | Tucson, Arizona 85724 |
| H Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
