Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285890
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-02-22
Brief Title:
Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-08
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:
To find a recommended dose of HC-7366 that can be given in combination with azacitidine and venetoclax to patients with AML The safety and effects of this drug combination will also be studied
Detailed Description:
Primary Objective
- To evaluate safety of the combination of azacitidine venetoclax and HC-7366
Secondary Objectives
To estimate rate of CRCRhCRi by 4 cycles
To estimate overall response rate ORR
To estimate rate of MRD negative by 4 cycles
To estimate overall survival OS
To estimate relapse-free survival RFS
Exploratory Objectives
To determine the plasma concentration and pharmacokinetic PK parameters of HC-7366 when dosed in combination with azole antifungals in AML patients
To estimate duration of response DOR
To estimate median time to blood count recovery
To estimate median time to first response
To estimate median time to negative MRD
To study drug-drug interactions with CYP3A4 inhibitor azole antifungals
Additional response and survival endpoints
To explore biomarkers of response pathway engagement and resistance
- To evaluate safety of the combination of azacitidine venetoclax and HC-7366
Secondary Objectives
To estimate rate of CRCRhCRi by 4 cycles
To estimate overall response rate ORR
To estimate rate of MRD negative by 4 cycles
To estimate overall survival OS
To estimate relapse-free survival RFS
Exploratory Objectives
To determine the plasma concentration and pharmacokinetic PK parameters of HC-7366 when dosed in combination with azole antifungals in AML patients
To estimate duration of response DOR
To estimate median time to blood count recovery
To estimate median time to first response
To estimate median time to negative MRD
To study drug-drug interactions with CYP3A4 inhibitor azole antifungals
Additional response and survival endpoints
To explore biomarkers of response pathway engagement and resistance
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01733 | OTHER | NCI-CTRP Clinical Registry | None |