A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations
Status:
Terminated
Trial end date:
2017-06-08
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2a dose-escalation study of E6201, a dual mitogen-activated protein
kinase/extracellular-signal regulated kinase 1 (MEK1) and FMS-like tyrosine kinase 3 (FLT3)
inhibitor, in subjects with advanced hematologic malignancies with documented FLT3 and/or rat
sarcoma (Ras) mutations. The Phase1 portion of the study will be a safety run-in (up to 30
subjects) to establish a recommended Phase 2 dose (RP2D). The Ph. 2a portion of the study
will evaluate three specific patients groups: Cohort 1 will enroll patients with relapsed or
refractory AML and confirmed FLT3 mutation (with or without a Ras mutation) without prior
exposure to a FLT3 inhibitor; Cohort 2 will enroll patients with relapsed or refractory AML
and confirmed FLT3 mutation (with or without a Ras mutation) with prior exposure to a FLT3
inhibitor; Cohort 3 will enroll patients with relapsed or refractory AML with a confirmed Ras
mutation and no FLT3 mutation.