A Randomized, Open Label Study of Oral CEP 701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT 3 Activating Mutations.Estudio abierto aleatorio del fármaco oral CEP-701 administrado consecutivamente con quimioterapia estándar en pacientes que han sufrido recaídas de leucemia mieloide aguda (LMA) mostrando mutaciones asociadas a la actividad del FLT-3

Cephalon Inc.0 sites120 target enrollmentSeptember 15, 2005

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed Acute Myeloid Leukaemia (AML) expressing FLT-3 activating mutations.
Sponsor: Cephalon Inc.
Enrollment: 120
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

September 15, 2005

End Date

January 13, 2010

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients are included in the study if all of the following criteria are met at the baseline visit:
•cytological confirmation of AML
•relapsed disease following first CR of a duration of 1 month (30 days) to 24 months (730 days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30 days.
•confirmation of FLT 3 activating mutation positive status after point of initial relapse
•aged 18 years and older
•written informed consent
•ability to understand and comply with study restrictions
•no comorbid conditions that would limit life expectancy to less than 3 months
•Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2
•women must be neither pregnant nor lactating, and either of nonchildbearing potential or using adequate contraception with a negative pregnancy test at study entry

•Patients are excluded from participating in this study if 1 or more of the following criteria are met:
•bilirubin levels greater than 2 times upper limit of normal (ULN), alanine transaminase or aspartate transaminase levels greater than 3 times ULN
•serum creatinine concentrations greater than 1\.5 mg/dL
•resting ejection fraction of left ventricle less than 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine \[MEC])
•untreated or progressive infection
•any physical or psychiatric condition that may compromise participation in the study
•known central nervous system involvement with AML
•any previous treatment with a FLT 3 inhibitor
•patient requires current treatment for the human immunodeficiency virus (HIV) with protease inhibitors
•active gastrointestinal ulceration or bleeding