A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 Mutation (AML) | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02418000

A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 Mutation (AML)
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This is a Phase 1/2a dose-escalation study of E6201, a dual MEK1 and FLT3 inhibitor, in subjects with advanced hematologic malignancies with documented FLT3 mutation. The Phase1 portion of the study will be a safety run-in to establish a recommended Phase 2 dose (RP2D). The Ph. 2a portion of the study will evaluate two specific patients groups: Cohort 1 will enroll up to 26 patients with relapsed or refractory AML and confirmed FLT3 mutation without prior exposure to a FLT3 inhibitor while Cohort 2 will enroll up to 12 patients with relapsed or refractory AML and confirmed FLT3 mutation with prior exposure to a FLT3 inhibitor. Each cohort of the expansion phase will incorporate a Simon 2-stage optimal design. A total of up to N=62 subjects will be enrolled in the study.

Status: 
Recruiting
Study Date: 
Wed, 04/01/2015 to Sun, 10/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: E6201 Single Group Assignment Other Name: novel inhibitor of FMS-like tyrosine kinase-3 (FLT3)