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Sponsored by: |
Eisai Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00619099 |
The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndrome |
Drug: Decitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Open-Label Phase 2 Study of Low Dose Dacogen® for Injection (Decitabine) in Patients With Low or Intermediate 1 Risk Myelodysplastic Syndromes |
Estimated Enrollment: | 80 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Decitabine
Schedule A: Decitabine will be administered Subcutaneous (SQ) daily for 3 consecutive days (Day 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days. Schedule B: Decitabine will be administered SQ every 7 days for 21 days (Day 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days. |
This is a randomized open-label Phase 2 efficacy and safety study of two (2) subcutaneous (SQ) dosing schedules of decitabine in subjects with Low or Intermediate 1 risk MDS. In Schedule A, decitabine will be dosed SQ at 20 mg/m^2/day for 3 consecutive days (1 to 3) every 28 days. In Schedule B, decitabine will be dosed SQ at 20 mg/m^2/day 1 time every 7 days for 21 days (Day 1, 8, and 15) followed by 7 days without an administration of decitabine. This study will be conducted in up to 6 study centers in the United States.
The primary efficacy outcome is the overall improvement rate (Complete Remission [CR] + Partial Remission [PR] + Marrow CR + Hematologic Improvement [HI]).
These two doses will be administered subcutaneously and are lower than the dose currently approved.
The probability that one schedule is superior to the other will be estimated, and the level of toxicity for each schedule will also be evaluated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each patient must meet the following criteria to be enrolled in this study:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study:
Contact: Eisai Medical Services | 1-888-422-4743 |
United States, Ohio | |
Gabrail Cancer Center | Recruiting |
Canton, Ohio, United States, 44718 | |
Contact: Carrie Smith 330-492-3345 ext 208 csmith@gabrailcancercenter.com | |
Principal Investigator: Nashat Gabrail, MD | |
United States, Rhode Island | |
Landmark Medical Center | Recruiting |
Woonsocket, Rhode Island, United States, 02895 | |
Contact: Lisa Furtado 401-769-4100 ext 2590 lfurtado@landmarkmedical.org | |
Principal Investigator: Ahmed Nadeem, MD | |
United States, Tennessee | |
Sarah Cannon Research | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Meredith Zimlich 615-329-7245 Meredith.Zimlich@scresearch.net | |
Principal Investigator: Daniel Couriel, MD | |
United States, Texas | |
M. D. Anderson | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Guillermo Garcia-Manero, MD 713-745-3428 ggarciam@mdanderson.org |
Responsible Party: | Eisai Inc. ( Eisai Medical Services ) |
Study ID Numbers: | DACO-026 |
Study First Received: | February 8, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00619099 |
Health Authority: | United States: Food and Drug Administration |
Myelodysplastic Syndrome Decitabine Dacogen MGI PHARMA, Inc. |
Myelodysplastic syndromes Preleukemia Precancerous Conditions Hematologic Diseases |
Myelodysplasia Myelodysplastic Syndromes Decitabine Bone Marrow Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Syndrome Enzyme Inhibitors Pharmacologic Actions |