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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow

Outcome Description:

Response rate of patients with refactory, relapsed, or poor risk acute myeloid leukemia (AML) expressing Fms-like tyrosine kinase 3 (FLT-3) activating mutations. CR is defined as presence of less than 5% myeloblasts in bone marrow with normalized peripheral blood cell counts. HR is defined as a 50% or more decrease in the absolute number of peripheral blast count or at least a 50% reduction in bone marrow blasts.

Outcome Time Frame:

56 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

C0701a/202/ON/US

NCT ID:

NCT00030186

Start Date:

January 2002

Completion Date:

February 2003

Related Keywords:

  • Leukemia, Myeloid
  • AML
  • FLT-3 mutation
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location