Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510289
Status:
TERMINATED
Last Update Posted:
2016-04-19
First Post:
2007-07-30
Brief Title:
Sorafenib in Myelodysplastic Syndrome
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Trial of Sorafenib in Patients With Myelodysplastic Syndrome
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early closure of study due to poor response
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 is to evaluate the efficacy of sorafenib in patients with Myelodysplastic Syndrome MDS Eligible subjects will receive Sorafenib administered at 400mg orally twice a day given on days 1-28 of a 28-day cycle Patients will be evaluated for hematological response after 2 cycles and then every 3 cycles thereafter for a maximum of 5 years from study entry If a patient achieves a complete response they may receive an additional 6 cycles of therapy beyond documentation of complete response unless unacceptable toxicity occurs For patients with partial response hematological improvement or stable disease they will continue treatment until relapse progression of disease or unacceptable toxicity occurs
Detailed Description:
None
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