Ignite Creation Date:
2024-05-05 @ 11:15 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01286038
Status:
TERMINATED
Last Update Posted:
2022-11-07
First Post:
2011-01-27
Brief Title:
Eltrombopag in Myelodysplastic Syndrome MDS Patients With Thrombocytopenia
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Eltrombopag in Myelodysplastic Syndrome MDS Patients With Thrombocytopenia Who Progressed or Are Resistant to Hypomethylating Agents
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
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 safety and efficacy of eltrombopag in people who have myelodysplastic syndrome MDS with thrombocytopenia who have progressed or are resistant to decitabine or azacitidine These are the only 2 drugs approved by the US Food and Drug Administration FDA which can improve platelet counts The investigators the study doctor study staff and sponsor want to find out what effects good or bad eltrombopag study drug may have on people with low platelet counts due to MDS The investigators will also be testing how well eltrombopag may work at different doses in these diseases
Detailed Description:
Study was originally designed as a Phase III but was terminated during the Phase I portion due to lack of efficacy
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