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

This study has been completed.

First Received: February 7, 2002 Last Updated: January 12, 2006 History of Changes

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00030186

Purpose

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.

Condition	Intervention	Phase
Leukemia, Myeloid	Drug: CEP-701 solution	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: CEP 701

U.S. FDA Resources

Further study details as provided by Cephalon:

Estimated Enrollment:	37
Study Start Date:	January 2002

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030186

Locations

United States, Maryland
Johns Hopkins Oncology Center, Bunting Blaustein Building
Baltimore, Maryland, United States, 21231
United States, Texas
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 70030

Sponsors and Collaborators

Cephalon

More Information

No publications provided

Study ID Numbers:	C0701a/202/ON/US
Study First Received:	February 7, 2002
Last Updated:	January 12, 2006
ClinicalTrials.gov Identifier:	NCT00030186 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

AML
FLT-3 mutation

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on November 27, 2009