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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. |
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Register:
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EUCTR |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
EUCTR2005-002258-23-IT |
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Date of registration:
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04/11/2005 |
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Prospective Registration:
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No |
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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
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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 |
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Date of first enrolment:
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07/07/2005 |
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Target sample size:
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220 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002258-23 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Number of treatment arms in the trial: 2
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Phase:
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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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Contacts
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Acute Myeloid Leukemia
MedDRA version: 14.1
Level: PT
Classification code 10059034
Term: Acute myeloid leukaemia recurrent
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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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: LESTAURTINIB
CAS Number: 111358-88-4
Current Sponsor code: CEP-701
Concentration unit: mg milligram(s)
Concentration number: 80-
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Primary Outcome(s)
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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
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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.
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Primary end point(s): The proportion of patients who achieve an outcome of complete remission at the outcome assessment (CR/CRp).
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Secondary ID(s)
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C0701a/204/ON/US
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2005-002258-23-ES
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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