Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445907
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-05-31
Brief Title:
Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
Status:
NOT_YET_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 learn about the safety and tolerability of the drug combination of Q702 azacitidine and venetoclax when given to participants with relapsedrefractory AML
Detailed Description:
Primary Objective
- To evaluate safety of Q702 and the combination of azacitidine venetoclax
Secondary Objectives
To estimate rate of CRCRhCRi by 4 treatment cycles
To estimate overall response rate ORR
To estimate rate of MRD negative by 4 treatment cycles
To estimate overall survival OS
To estimate relapse-free survival RFS
Exploratory Objectives
To determine the plasma concentration and pharmacokinetic PK parameters of Q702 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 Q702 and the combination of azacitidine venetoclax
Secondary Objectives
To estimate rate of CRCRhCRi by 4 treatment cycles
To estimate overall response rate ORR
To estimate rate of MRD negative by 4 treatment cycles
To estimate overall survival OS
To estimate relapse-free survival RFS
Exploratory Objectives
To determine the plasma concentration and pharmacokinetic PK parameters of Q702 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04788 | OTHER | NCI-CTRP Clinical Registry | None |