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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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11 January 2016 |
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Main ID: |
EUCTR2008-004019-36-SK |
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Date of registration:
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10/02/2009 |
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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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Open label extension study of lanreotide Autogel 120 mg in patients with non functioning entero-pancreatic endocrine tumour. - Not applicable
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Scientific title:
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Open label extension study of lanreotide Autogel 120 mg in patients with non functioning entero-pancreatic endocrine tumour. - Not applicable |
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Date of first enrolment:
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04/03/2009 |
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Target sample size:
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140 |
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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:2008-004019-36 |
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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: no
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
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Phase:
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Countries of recruitment
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Belgium
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Czech Republic
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France
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Italy
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Poland
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Slovakia
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Spain
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
All patients must fulfil the following:
- Has provided written informed consent prior to any study-related procedures.
- Has been enrolled and treated in the frame of the 2-55-52030-726 protocol and either:
? Was stable at 96 weeks of treatment (whatever the treatment received during the two years of participation i.e no code break at Week 96).
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? Has received at least one injection in the frame of the 2-55-52030-726 protocol and had a disease progression, confirmed by central assessment, during the course of the study and code break showed a placebo arm.
- Has a World Health Organisation (WHO) performance score lower or equal to 2.
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 will not be included in the study if the patient :
- Has been enrolled and treated in the frame of the 2-55-52030-726 protocol and had a disease progression during the study and the code break showed a treatment with lanreotide Autogel 120mg.
- Has received any new treatment for the entero pancreatic neuro endocrine tumour since the end of participation in the 2-55-52030-726 study.
- Is likely to require any additional concomitant treatment to the lanreotide Autogel 120mg for the entero-pancreatic neuro endocrine tumour.
- Has been treated with radionuclide at any time prior to study entry.
- Has a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120mg.
- Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
- Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilisation or hysterectomy at least 3 months before the start of the study.
- Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- Has abnormal findings at visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- Has been previously enrolled in this study
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Non functioning entero-pancreatic tumour
MedDRA version: 8.1
Level: PT
Classification code 10052399
Term: Neuroendocrine tumour
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Intervention(s)
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Trade Name: SOMATULINE AUTOGEL 120 MG
Product Name: Lanreotide Autogel 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lanreotide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
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Primary Outcome(s)
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Secondary Objective: The secondery objective is to assess the long term efficacy of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero-pancreatic neuro endocrine tumour.
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Main Objective: The primary objective is to assess the long term safety of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero-pancreatic neuro endocrine tumour.
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Primary end point(s): The primary criterion for the assessment of safety will be an investigation into the incidence of adverse events. The other safety endpoints are:
• Vital signs
• Physical examination
• ECG
• Gallbladder echography
• Laboratory tests: standard haematology and biochemistry
• Concomitant medication
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Secondary ID(s)
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Protocol 2-55-52030-729
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2008-004019-36-FR
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Not applicable
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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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