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 - NA

• Conditions: Relapsed Acute Myeloid Leukaemia (AML) expressing FLT-3 activating mutations.; MedDRA version: 9.1Level: LLTClassification code 10000886Term: Acute myeloid leukemia

• Registration Number: EUCTR2005-002258-23-DE
• Lead Sponsor: Cephalon Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
•use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatmentt

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified