Trial | NCT00030186  Report issue

Title

Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lestaurtinib ...

  • Study Participants

    37
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.
This is an open-label study of CEP-701 in patients with refractory, relapsed, or poor risk AML expressing FLT-3 activating mutations. Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). Upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.
Study Started
Jan 31
2002
Primary Completion
Feb 28
2003
Study Completion
Feb 28
2003
Last Update
Aug 23
2012
Estimate

Drug CEP-701 60mg

60mg orally 2 times a day for 28 days

Drug Cep-701 80mg

80mg 2 times a day, dependent upon response to cycle 1

Drug Cep-701 40mg

40mg 2 times a day, dependent upon response to cycle 1

Cycle 1 Experimental

60mg

Cycle 2 Experimental

80mg dependent upon response to Cycle 1

Cycle 2b Experimental

40mg dependent upon response to Cycle 1

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
No Results Posted