Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282399
Status:
TERMINATED
Last Update Posted:
2015-10-28
First Post:
2006-01-25
Brief Title:
A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Phase III Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 study but only the Phase 1 part was conducted due to a change in product development strategy
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 12 study but only the Phase 1 part was conducted due to a change in product development strategy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None