Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
Leukemia, Myeloid
About this trial
This is an interventional treatment trial for Leukemia, Myeloid focused on measuring AML, FLT-3 mutation
Eligibility Criteria
INCLUSION CRITERIA: patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation patient must have life expectancy of more than 2 months patient must be fully recovered from reversible side effects of previous therapy for cancer EXCLUSION CRITERIA: total bilirubin, ALT or AST greater than 2 times upper limit of normal patient <65 years of age with estimated creatinine clearance less than 60 mL/min; patient >65 years of age with serum creatinine > 1.5 times the upper limit of normal (ULN) received any investigational drug within past 4 weeks GI disturbance/malabsorption that may affect absorption of CEP-701 HIV positive received NSAID within prior 14 days has active infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cycle 1
Cycle 2
Cycle 2b
60mg
80mg dependent upon response to Cycle 1
40mg dependent upon response to Cycle 1