Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284460
Status:
WITHDRAWN
Last Update Posted:
2024-04-03
First Post:
2024-02-21
Brief Title:
Phase III Study of a Combination of Decitabine and Cedazuridine ASTX727 and ASTX029 an ERK Inhibitor for Patients With RAS Pathway Mutant Myelodysplastic Syndromes and MyelodysplasticMyeloproliferative Neoplasms
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of a Combination of Decitabine and Cedazuridine ASTX727 and ASTX029 an ERK Inhibitor for Patients With RAS Pathway Mutant Myelodysplastic Syndromes and MyelodysplasticMyeloproliferative Neoplasms
Status:
WITHDRAWN
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug Source Request
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of ASTX029 that can be given in combination with ASTX727 to participants who have RAS-mutant MDS or MDSMPN The goal of Part 2 of this clinical research study is to learn if the dose of ASTX029 found in Part 1 can help to control the disease when used in combination with ASTX727
Detailed Description:
Primary Objectives
Phase 1 dose escalation to determine safety tolerability and MTD of ASTX029 in RAS mutant MDS CMML and other MDSMPN
Phase 2 dose expansion to determine the safety tolerability and overall response rate ORR of ASTX727 in combination with ASTX029 in RAS mutant MDS CMML and other MDSMPN
Incidence of AEs MTD and changes in clinical laboratory values
Measures of efficacy overall response rate ORR defined as sum of CR complete cytogenetic remission partial remission marrow response clinical benefit for MDSMPN and defined as CR mCR PR HI in MDS
Secondary Objectives
To determine other efficacy outcomes such as duration of response leukemia-free survival LFS progression-free survival PFS and overall survival OS
To evaluate differences in response and efficacy outcomes by MDSMPN IWG response criteria based on disease subtypes and genomic features
Correlative studies
To evaluate changes in clonal composition and VAF of identified mutations with therapy
To evaluate the pharmacokinetics PK and pharmacodynamics PD of ASTX029 and the combination of ASTX727 with ASTX029 in patients with RAS mutant MDS CMML and other MDSMPN
Phase 1 dose escalation to determine safety tolerability and MTD of ASTX029 in RAS mutant MDS CMML and other MDSMPN
Phase 2 dose expansion to determine the safety tolerability and overall response rate ORR of ASTX727 in combination with ASTX029 in RAS mutant MDS CMML and other MDSMPN
Incidence of AEs MTD and changes in clinical laboratory values
Measures of efficacy overall response rate ORR defined as sum of CR complete cytogenetic remission partial remission marrow response clinical benefit for MDSMPN and defined as CR mCR PR HI in MDS
Secondary Objectives
To determine other efficacy outcomes such as duration of response leukemia-free survival LFS progression-free survival PFS and overall survival OS
To evaluate differences in response and efficacy outcomes by MDSMPN IWG response criteria based on disease subtypes and genomic features
Correlative studies
To evaluate changes in clonal composition and VAF of identified mutations with therapy
To evaluate the pharmacokinetics PK and pharmacodynamics PD of ASTX029 and the combination of ASTX727 with ASTX029 in patients with RAS mutant MDS CMML and other MDSMPN
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-2024-01692 | OTHER | NCI-CTRP Clinical Registry | None |