Ignite Creation Date:
2024-05-06 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05209152
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2022-01-13
Brief Title:
AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 1 Study of AMG 176 as Monotherapy and in Combination With Azacitidine in Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2024-04
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 main objective is to assess the safety tolerability and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia HR-MDSCMML
Detailed Description:
This study is a Phase 1 clinical trial designed to assess the safety tolerability and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of HR-MDSCMML Participants will be treated with intravenous IV AMG 176 and IV or subcutaneous SC azacitidine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None