- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282399
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- University of Arizona Cancer Center
-
-
Florida
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Tampa, Florida, United States, 33612
- H Lee Moffitt Cancer Center & Research Institute
-
-
New York
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Bronx, New York, United States, 10461
- Albert Einstein College Of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).
Exclusion Criteria:
- Prior therapy with decitabine or azacytidine (Vidaza).
- Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
- Clinically significant anemia.
- Prior history of malignancy other than MDS.
- Any active infection.
- Radiotherapy within 14 days prior to study enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DACO-019 2mg/m^2
DACO-019 2mg/m^2 twice daily (BID)
|
|
Experimental: DACO-019 5mg/m^2
DACO-019 5mg/m^2 BID
|
|
Experimental: DACO-019 10mg/m^2
DACO-019 10mg/m^2 BID
|
What is the study measuring?
Primary Outcome Measures
Outcome 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.
Time Frame: Up to 8 cycles (224 days)
|
Up to 8 cycles (224 days)
|
Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.
Time Frame: Up to 12 cycles (336 days)
|
Up to 12 cycles (336 days)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DACO-019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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