Trials / Terminated
TerminatedNCT00282399
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.
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Subcutaneous Decitabine |
Timeline
- Start date
- 2006-10-01
- Primary completion
- 2008-10-01
- Completion
- 2009-02-01
- First posted
- 2006-01-26
- Last updated
- 2015-10-28
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00282399. Inclusion in this directory is not an endorsement.