Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Mixed Phenotype Acute Leukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Patients will be accrued using a 3+3 approach. Cohorts will be escalated based on review of safety data for each patient and cohort. The highest dose level administered prior to the dose in which ? 33% of patients experience a dose-limiting toxicity [DLT]) will be defined as the MTD. Based on PK, pharmacodynamic data, efficacy, safety and patient tolerability, a recommended dose for further development (RP2D) may be identified that is less than the formal MTD. A dose expansion arm of approximately 12 patients (with 6 patients being FLT3 ITD+ and 6 patients being Mer+/FLT3 WT) will be accrued to further evaluate patients at the RP2D.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
This is a Phase I, open-label, non-randomized, dose escalation study in up to 50 adolescent or adult patients with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive a single dose of MRX-2843 followed by continuous oral ...
This is a Phase I, open-label, non-randomized, dose escalation study in up to 50 adolescent or adult patients with relapsed/refractory 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 Mer+/FLT3 WT) will be accrued to further evaluate patients at the RP2D.
Tracking Information
- NCT #
- NCT04872478
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Melinda Pauley, MD Emory University, Children's Healthcare of Atlanta Principal Investigator: William Blum, MD Emory University Principal Investigator: Thomas Alexander, MD UNC Lineberger Comprehensive Cancer Center, Children's Principal Investigator: Joshua Zeidner, MD UNC Lineberger Comprehensive Cancer Center
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