Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501120
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2020-08-03
Brief Title:
Study of APG2575 Single Agent and Combination With Therapy in Patients RelapsedRefractory AML
Sponsor:
Ascentage Pharma Group Inc
Organization:
Ascentage Pharma Group Inc
Study Overview
Official Title:
A Phase Ib Study of the Safety Pharmacokinetic of APG-2575 Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With RelapsedRefractory AML
Status:
RECRUITING
Status Verified Date:
2024-10
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 safety pharmacokinetic profile of APG-2575 single agent and in combination with HHTAZA in patients with relapsedrefractory AML and related myeloid malignancies
Detailed Description:
This is an open-label multi-center Phase Ib study of safety PK of APG-2575 as single agent or in combination with HHT or AZA in relapsedrefractory AML and related myeloid malignancies patients
This study consists of three stages The first stage is the APG-2575 single agent dose-escalation study The second stage is the APG-2575 combined with HHTAZA dose-escalation study The third stage is the MTDRP2D expansion cohort study of the combination regimen
This study consists of three stages The first stage is the APG-2575 single agent dose-escalation study The second stage is the APG-2575 combined with HHTAZA dose-escalation study The third stage is the MTDRP2D expansion cohort study of the combination regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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