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 - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-002258-23-SE
• Date of registration: 12/07/2006
• Prospective Registration: Yes
• Primary sponsor: Cephalon, Inc.
• Public title: 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 - N/A
• Scientific title: 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 - N/A
• Date of first enrolment: 15/11/2006
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002258-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany, Italy, Spain, Sweden

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Product Name: Lestaurtinib
Product Code: CEP-701
Pharmaceutical Form: Oral solution
INN or Proposed INN: Lestaurinib
CAS Number: 111358-88-4
Current Sponsor code: CEP-701
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Main Objective: The primary objective is to determine whether CEP 701 treatment given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR) or a CR with incomplete platelet recovery (CRp).

Primary end point(s): The proportion of patients who achieve an outcome of complete remission at the outcome assessment (Cr/CRp).
The secondary variables are as follows:
• overall survival for all patients
• event-free survival for all patients
• remission duration (for patients who achieve a CR)
• achievement of an outcome of CR, CRp or PR
• maintenance an outcome of CR/CRp up to day 113
• achievement of an outcome of CR/CRp after crosing sover to treatment with CEP-701

Secondary Objective: The secondary objectives of the study are to determine the following:
• overall survival
• event-free survival
• remission duration (for patients who achieve a CR or a CRp (CR/CRp))
• the proportion of patients who achieve an outcome of CR, CRp, or partial remission (PR)
• the proportion of patients who maintain an outcome of CR/CRp up to day 113
• the proportion of patients who achieve an outcome of CR/CRp after crossing over to treatment with CEP-701
• the safety and tolerability of CEP-701 treatment administered in sequence with chemotherapy throughout the study
• the pharmacokinetics of CEP-701 treatment at specified time points
• CEP-701 inhibitory activity in plasma by means of a FLT 3 (fms-like tyrosine kinase 3) exvivo bioassay and cell assay at specified time points

Secondary ID(s)

N/A

2005-002258-23-ES

C0701a-204-ON-US