Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445959
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-31
Brief Title:
Phase 1b2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase 1b2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
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:
To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML
Detailed Description:
Primary Objectives
Phase 1b To determine the safety and tolerability and recommended phase 2 dose RP2D of decitabine either IV or oral decitabinecedazuridine ASTX727 Inqovi and venetoclax in combination with olutasidenib
Phase 2 To determine the composite remission rate CR CRh and CRi of decitabine IV or oral decitabinecedazuridine ASTX727 Inqovi and venetoclax in combination with olutasidenib for newly diagnosed Arm A or relapsedrefractory Arm B participants with IDH1-mutated myeloid malignancy
Secondary Objectives
To determine duration of response DOR event-free survival EFS and overall survival OS
To evaluate occurrence of minimal residual disease MRD negative status by multiparameter flow cytometry and molecular evaluation
To determine the overall response rate CR CRh CRi MLFS and PR
To characterize the pharmacokinetic PK profiles of venetoclax and olutasidenib in plasma samples Phase 1b only
Exploratory Objectives
- To investigate global gene expression profiles DNA methylation profiles BH3 profiling and other potential prognostic markers to explore predictors of antitumor activity andor resistance to treatment
Phase 1b To determine the safety and tolerability and recommended phase 2 dose RP2D of decitabine either IV or oral decitabinecedazuridine ASTX727 Inqovi and venetoclax in combination with olutasidenib
Phase 2 To determine the composite remission rate CR CRh and CRi of decitabine IV or oral decitabinecedazuridine ASTX727 Inqovi and venetoclax in combination with olutasidenib for newly diagnosed Arm A or relapsedrefractory Arm B participants with IDH1-mutated myeloid malignancy
Secondary Objectives
To determine duration of response DOR event-free survival EFS and overall survival OS
To evaluate occurrence of minimal residual disease MRD negative status by multiparameter flow cytometry and molecular evaluation
To determine the overall response rate CR CRh CRi MLFS and PR
To characterize the pharmacokinetic PK profiles of venetoclax and olutasidenib in plasma samples Phase 1b only
Exploratory Objectives
- To investigate global gene expression profiles DNA methylation profiles BH3 profiling and other potential prognostic markers to explore predictors of antitumor activity andor resistance to treatment
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-2024-04807 | OTHER | NCI-CTRP Clinical Registry | None |