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Sponsored by: |
MGI PHARMA, Inc. |
Information provided by: | MGI PHARMA, Inc. |
ClinicalTrials.gov Identifier: | NCT00619099 |
The purpose of this study is to find out the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with MDS. These two doses will be administered subcutaneously and are lower than the dose currently approved.
Condition | Intervention | Phase |
Myelodysplastic Syndrome |
Drug: Decitabine |
Phase II |
ChemIDplus related topics: | 5-Aza-2'-deoxycytidine |
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) |
Schedule A Decitabine will be administered SQ daily for 3 consecutive days (Day 1 to 3) every 28 days. The dose will be 20 mg/m2/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/m2/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/m2/day for 3 consecutive days (1 to 3) every 28 days. In Schedule B, decitabine will be dosed SQ at 20 mg/m2/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]).
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: Medical Communications | 1-800-562-5580 |
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 | |||||
MD Anderson | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Guillermo Garcia-Manero, MD 713-745-3428 ggarciam@mdanderson.org |
MGI PHARMA, Inc. |
Responsible Party: | MGI ( Senior Vice President, Medical and Scientific Affairs ) |
Study ID Numbers: | DACO-026 |
First Received: | February 8, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00619099 |
Health Authority: | United States: Food and Drug Administration |
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