Trials / Terminated
TerminatedNCT01011283
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
A Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of DACOGEN (Decitabine) for Injection and VIDAZA (Azacitidine) for Injection In Subjects With Intermediate or High Risk Myelodysplastic Syndromes (MDS)
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | decitabine | decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days |
| DRUG | azacitidine | azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2011-01-01
- First posted
- 2009-11-11
- Last updated
- 2014-10-29
- Results posted
- 2013-09-18
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01011283. Inclusion in this directory is not an endorsement.