Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251511
Status:
TERMINATED
Last Update Posted:
2012-05-11
First Post:
2005-11-08
Brief Title:
A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome
Sponsor:
Veeda Oncology
Organization:
Veeda Oncology
Study Overview
Official Title:
A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor terminated trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II open-label non-randomized study in patients with low intermediate-1 intermediate-2 or high-risk MDS defined by IPSS
Each cycle of treatment will be 6 weeks in length Patients will be evaluated every 6 weeks for response Patients will be treated for a minimum of 12 weeks even in the absence of response Following 12 weeks of treatment patients will continue to receive study treatment until disease progression or unacceptable toxicity
Each cycle of treatment will be 6 weeks in length Patients will be evaluated every 6 weeks for response Patients will be treated for a minimum of 12 weeks even in the absence of response Following 12 weeks of treatment patients will continue to receive study treatment until disease progression or unacceptable toxicity
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