Spots Global Cancer Trial Database for Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
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Trial Identification
Brief Title: Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL
Official Title: An Open Label Evaluation Phase 1 Trial of the Safety and Pharmacokinetics of MRX-2843 in Adolescents and Adults With Relapsed/Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Mixed Phenotype Acute Leukemia
Study ID: NCT04872478
Interventions
Study Description
Brief Summary: This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed/refractory 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 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.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Emory University - WINSHIP Cancer Center, Atlanta, Georgia, United States
Emory University, Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Contact Details
Name: Melinda Pauley, MD
Affiliation: Emory University, Children's Healthcare of Atlanta
Role: PRINCIPAL_INVESTIGATOR
Name: William Blum, MD
Affiliation: Emory University
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas Alexander, MD
Affiliation: UNC Lineberger Comprehensive Cancer Center, Children's
Role: PRINCIPAL_INVESTIGATOR
Name: Joshua Zeidner, MD
Affiliation: UNC Lineberger Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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