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Main
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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 September 2021 |
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Main ID: |
EUCTR2005-005542-39-ES |
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Date of registration:
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20/02/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Estudio de extensión abierto del fármaco oral CEP-701 en pacientes con enfermedades malignas hematológicas y no hematológicas que han participado en un estudio clínico del CEP-701
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Scientific title:
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Estudio de extensión abierto del fármaco oral CEP-701 en pacientes con enfermedades malignas hematológicas y no hematológicas que han participado en un estudio clínico del CEP-701 |
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Date of first enrolment:
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29/03/2006 |
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Target sample size:
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100 |
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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:2005-005542-39 |
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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: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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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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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Participation in a previous clinical study of oral CEP 701 and would benefit by continuing treatment with CEP 701. Patients randomized to chemotherapy alone in study C0701a/204/ON/US may also be included in this study if in the opinion of their physician they might benefit by receiving oral CEP-701.
- Aged 18 years or older.
Written informed consent is obtained.
- Diagnosis of hematologic or non hematologic malignancy.
- Patient must be willing and able to comply with study restrictions and to return to the clinic for clinical and follow up evaluations as specified in this protocol.
- Enter this study within 30 days after participating in the previous clinical study of oral CEP 701; or, if the patient received chemotherapy after the previous study of oral CEP 701, within an interval of 3 to14 days after receiving the final dose of chemotherapy.
- Women must be neither pregnant or lactating, and either not of child-bearing potential or using adequate contraception with a negative pregnancy test result 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:
- Active gastrointestinal ulceration or bleeding.
- 1 or more of the following abnormal clinical chemistry laboratory values:
->bilirubin is more than 2 times the upper limit of normal (ULN)
->alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than 3 times ULN
- Serum creatinine is more than 2.0 mg/dl
- Non hematologic malignancy and 1 or more of the following abnormal hematology values:
->hemoglobin is below 9 g/dl
->platelet counts are below 100000/µl
->Absolute neutrophil counts are below 1500/µl
- The patient requires current treatment for the human immunodeficiency virus (HIV) with protease inhibitors or requires potent CYP3A4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, voriconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin, and nefazodone
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with hematologic and non hematologic malignancies who have participated in a clinical study of CEP 701 may participate in this extension study.
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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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
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Primary Outcome(s)
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Main Objective: To assess the safety and tolerability of long term administration of CEP 701 in patients with advanced malignancy.
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Primary end point(s): - Safety and tolerability will be assessed by evaluating adverse events (comprising withdrawals due to adverse events and serious adverse events including deaths), results of clinical laboratory tests, vital signs measurements, physical examination findings, and concomitant medication usage.
- Time to objective disease progression will be determined as the number of days from the baseline visit to the day of assessment of objective disease progression in this extension study.
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Secondary Objective: To measure the time to objective disease progression.
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Secondary ID(s)
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C0701a/501/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: 07/02/2006
Contact:
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