Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon

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