Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064974
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2003-07-16
Brief Title:
Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
Sponsor:
Celgene Corporation
Organization:
Celgene
Study Overview
Official Title:
A Multicenter Single-Arm Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2013-04
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:
This study is a multi-center single-arm open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days 28-day cycles to red blood cell RBC transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del 5q31-33 cytogenetic abnormality Screening procedures will take place within 28 days of first day of study drug treatment Subjects will receive study drug CC-5013 in 28-day cycles for up to 6 cycles or until bone marrow disease progression or progressionrelapse following erythroid hematologic improvement Appendix I is documented Study visits will occur every cycle every 28 days and laboratory monitoring to assess hematological parameters will occur every 14 days Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments
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