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

Conditions: Acute Myeloid Leukemia
MedDRA version: 14.1Level: PTClassification code 10059034Term: Acute myeloid leukaemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2005-002258-23-IT

Lead Sponsor: CEPHALON EUROPE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

?Cytological confirmation of AML ?Relapsed disease following first CR of duration 1 - 24 months Time from first relapse to study entry £ 30 days ?Confirmation of FLT 3 positive status after point of initial relapse ?Aged ³ 18 years and older ?Written informed consent ?Ability to understand and comply with study restrictions ?No co-morbid conditions that would limit life expectancy to <3 months ?ECOG 0 - 2 ?Pregnancy precautions as appropriate
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

?Bilirubin >2 times ULN, ALT or AST >3 times ULN ?Serum creatinine >1.5 mg/dL ?Resting ejection fraction <45% (MEC patients only) ?Untreated or progressive infection ?Physical or psychiatric condition that may compromise participation ?Known central nervous system involvement with AML ?Any prior treatment with a FLT 3 inhibitor ?Requirement for HIV protease inhibitors ?Active gastrointestinal ulceration or bleeding ?Use an investigational drug that is not expected to be cleared by the start of CEP-701

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to determine whether CEP 701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second CR/CRp.;Primary end point(s): The proportion of patients who achieve an outcome of complete remission at the outcome assessment (CR/CRp).;Secondary Objective: ?Overall Survival ?Event-free Survival ?Remission duration for patients who achieve a CR/CRp ?Proportion of patients who achieve an outcome of PR ?Proportion of patients who maintain an outcome of CR/CRp up to day 113 ?Proportion of patients who achieve an outcome of CR/CRp after crossing over to treatment with CEP-701 ?Safety and tolerability of CEP-701 ?PK of CEP-701 ?CEP-701 inhibitory activity in plasma by means of a FLT-3 ex-vivo bioassay

Secondary Outcome Measures