Back to resultsA Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
Primary Purpose
Myelodysplastic Syndrome
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Subcutaneous Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Myelodysplastic Syndrome, MGI Pharma, Decitabine, Dacogen
Eligibility Criteria
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.
Sites / Locations
- University of Arizona Cancer Center
- H Lee Moffitt Cancer Center & Research Institute
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
DACO-019 2mg/m^2
DACO-019 5mg/m^2
DACO-019 10mg/m^2
Arm Description
DACO-019 2mg/m^2 twice daily (BID)
DACO-019 5mg/m^2 BID
DACO-019 10mg/m^2 BID
Outcomes
Primary Outcome Measures
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.
Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00282399
Brief Title
A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
Official Title
Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Myelodysplastic Syndrome, MGI Pharma, Decitabine, Dacogen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DACO-019 2mg/m^2
Arm Type
Experimental
Arm Description
DACO-019 2mg/m^2 twice daily (BID)
Arm Title
DACO-019 5mg/m^2
Arm Type
Experimental
Arm Description
DACO-019 5mg/m^2 BID
Arm Title
DACO-019 10mg/m^2
Arm Type
Experimental
Arm Description
DACO-019 10mg/m^2 BID
Intervention Type
Drug
Intervention Name(s)
Subcutaneous Decitabine
Primary Outcome Measure Information:
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
H Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mgipharma.com
Description
MGI PHARMA's official website
Learn more about this trial
A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
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