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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 October 2021 |
Main ID: |
EUCTR2005-002258-23-ES |
Date of registration:
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15/09/2005 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
Date of first enrolment:
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07/11/2005 |
Target sample size:
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120 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002258-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: yes Open: no Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Italy
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Spain
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Sweden
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Key inclusion & exclusion criteria
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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 within 30 days of the baseline visit
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Relapsed Acute Myeloid Leukaemia (AML) expressing FLT-3 activating mutations.
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Intervention(s)
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Product Name: Lestaurtinib Product Code: CEP-701 Pharmaceutical Form: Oral solution INN or Proposed INN: Lestaurinib CAS Number: 111358-88-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
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Primary Outcome(s)
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Primary end point(s): The proportion of patients who achieve an outcome of complete remission at the outcome assessment. The secondary variables are as follows: • the proportion of patients who achieve an outcome of CRi or PR • the proportion of patients who maintain an outcome of CR up to day 113 • the proportion of patients who achieve an outcome of CR at day 113 who crossover to sequential treatment with CEP 701 • remission duration (for patients who achieve a CR) • event-free survival for all patients • overall survival for all patients
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Main Objective: The primary objective is to determine whether CEP 701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR) at the outcome assessment.
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Secondary Objective: The secondary objectives of the study are to determine the following: • the proportion of patients who achieve an outcome of CR with incomplete blood count recovery (CRi) • the proportion of patients who achieve an outcome of partial remission (PR) • the proportion of patients who maintain an outcome of CR up to day 113 • the proportion of patients who crossover to sequential CEP 701 treatment who achieve an outcome of CR at day 113 • remission duration (for patients who achieve a CR) • event-free survival • overall survival • safety and tolerability of CEP 701 administered in sequence with chemotherapy throughout the study • pharmacokinetics of CEP 701 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
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Secondary ID(s)
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C0701a/204/ON/US
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 09/09/2005
Contact:
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