Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872478
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2021-04-29
Brief Title:
Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With RelapsedRefractory AML ALL or MPAL
Sponsor:
Meryx Inc
Organization:
Meryx Inc
Study Overview
Official Title:
An Open Label Evaluation Phase 1 Trial of the Safety and Pharmacokinetics of MRX-2843 in Adolescents and Adults With RelapsedRefractory Acute Myeloid Leukemia Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia
Status:
RECRUITING
Status Verified Date:
2023-08
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:
This is a Phase I open-label non-randomized dose escalation study in adolescents and adults with relapsedrefractory acute myeloid leukemia acute lymphoblastic leukemia or mixed phenotype acute leukemia Patients will receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts
Detailed Description:
This is a Phase I open-label non-randomized dose escalation study in up to 50 adolescent or adult patients with relapsedrefractory acute myeloid leukemia acute lymphoblastic leukemia or mixed phenotype acute leukemia Patients will receive a single dose of MRX-2843 followed by continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts
A dose expansion arm of approximately 12 patients with 6 patients being FLT3 ITD and 6 patients being MerFLT3 WT will be accrued to further evaluate patients at the RP2D
A dose expansion arm of approximately 12 patients with 6 patients being FLT3 ITD and 6 patients being MerFLT3 WT will be accrued to further evaluate patients at the RP2D
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