Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549790
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Study of NMS-03597812 in Adult Patients With RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IaIb Study of NMS-03597812 in Adult Patients With RelapsedRefractory Acute Myeloid Leukemia Including Patients With TP53 Mutations
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of PERKA-812-003 study is to investigate the safety pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in RelapsedRefractory Acute Myeloid Leukemia RR AML patients who have exhausted standard treatment including a subset of patients with TP53 mutations It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment once the Recommended Range Dose RDR as single agent has been defined
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