Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109538
Status:
TERMINATED
Last Update Posted:
2015-05-01
First Post:
2005-04-28
Brief Title:
Study of Lonafarnib Versus Placebo in Subjects With Either Myelodysplastic Syndrome MDS or Chronic Myelomonocytic Leukemia CMML Study P02978AM3TERMINATED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Pivotal Randomized Study of Lonafarnib Versus Placebo in the Treatment of Subjects With Myelodysplastic Syndrome MDS or Chronic Myelomonocytic Leukemia CMML Who Are Platelet Transfusion Dependent With or Without Anemia
Status:
TERMINATED
Status Verified Date:
2015-04
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 is to assess the benefit of lonafarnib versus placebo in patients with myelodysplastic syndrome MDS or chronic myelomonocytic leukemia CMML Benefit will be measured by achievement of platelet transfusion independence for at least 8-consecutive weeks and without simultaneous worsening of hemoglobin andor need for red blood cell RBC transfusion Additional endpoints will be hematologic response which includes complete remission partial remission hematologic improvement number of RBC transfusions bleeding events infections and safety
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