A Phase IV (post marketing), multicentre, open label, single group study to look at the clinical value of counting Circulating Tumour Cells in order to predict the clinical response in patients receiving deep injections of Somatuline Autogel into the fat layer of the skin to treat the symptoms of functioning Neuroendocrine Tumours (tumours which secrete hormones) which are located in the intestines.
- Conditions
- Symptoms of Neuro Endocrine tumoursMedDRA version: 14.1 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2013-002194-22-GB
- Lead Sponsor
- Ipsen Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Patients MUST satisfy all of the following entry criteria before they will be allowed to participate in the study:
•Provision of written informed consent prior to any study related procedures. In this study consent may be provided by the legal guardian or carer. See section 5.2
•Patients (either sex) must be 18 years or older.
•Patients must have a documented diagnosis of a functioning midgut NET.
•In order to avoid patients with rapidly progressing tumours, only patients with well or moderately differentiated tumours and with a Ki67 proliferation index of <20% will be recruited.
•The clinically appropriate treatment for the patient must primarily be monotherapy with a somatostatin analogue.
•Patients must have had either a positive somatostatin receptor scintigraphy result or a positive 68 Gallium-DOTATATE PET imaging result.
•Patients must have a documented urinary or plasma 5-HIAA result within the year prior to study entry which is above the laboratory reference range.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
If any of the following apply, the patient MUST not enter/continue in the study:
•If the patient is at risk of pregnancy or is breast feeding, unless treatment with Somatuline Autogel is clearly needed (as determined by the clinician).
•The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
•The patient has been treated with any other unlicensed drug within the last 30 days before study entry or will require a concurrent treatment with any other experimental drugs or treatments.
•The patient has been treated with a somatostatin analogue prior to study entry, unless a washout period of at least 2 weeks for subcutaneous octreotide, or at least 6 weeks for a single dose of long acting somatostatin analogue has occurred.
•The patient requires medical treatment for the symptoms of the NET other than primarily monotherapy with a somatostatin analogue.
•The patient has received interferon, chemotherapy, chemoembolisation or radionuclide therapy within 3 months prior to study entry.
•The patient has a history of hypersensitivity to drugs with a similar chemical structure.
•Females of childbearing potential must provide a negative pregnancy test at the start of the study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as being post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
•The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method