Symptoms of Neuro Endocrine tumours MedDRA version: 14.1 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Somatuline® Autogel® 60mg
Product Name: Somatuline® Autogel® 60mg
Product Code: PL 34926/0005
Pharmaceutical Form: Solution for injection in
Sponsors
Ipsen Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective in the study is to assess whether counting the number of circulating tumour cells (CTCs) in the bloodstream of patients with functioning neuroendocrine tumours (NETs) (tumours which release hormones) in the midgut region is an effective tool to predict how the symptoms patients suffer from will respond when they are taking Somatuline Autogel. This process will be of considerable benefit to patients if it is shown to be effective as it will, in effect, be a ‘liquid biopsy’ procedure which is minimally invasive and relatively quick. It will help to optimise treatment decisions for patients in the future. The primary exploratory objective is to see whether counting the number of circulating tumour cells (CTCs)in the bloodstream of patients with funtioning neuroendocrine tumours (NETs)in the midgut region is able to predict how long these patients will survive before their disease progresses. ; Secondary Objective: To assess the effect of Somatuline Autogel on the symptoms of diarrhoea (frequent loose stools) and flushing (redness) in patients with a functioning NETs (neuroendocrine tumours which produce hormones). This will be done by using the IVRS automated call system to record and evaluate these symptoms. To assess the effect of Somatuline Autogel treatment on the patients’ quality of life. This will be done using the EORTC QLQ-NET21 and the EORTC-QLQ-C30 questionnaires which patients will be asked to complete at enrollment, and at weeks 13, 25 and 53. Assessment of progression free survival at one year. Patients will have a CT or MRI scan at screening, week 25 and 53 and the difference seen in the patients tumours from screening to the end of the study will be assessed using the RECIST criteria (Response Evaluation Criteria In Solid Tumors). RECIST is a set of published rules that define when cancer patients improve ("respond"), stay the same (are | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints And Evaluations: To assess the effect of Somatuline Autogel on the symptoms of diarrhoea and flushing in patients with a functioning NET. To assess the effect of Somatuline Autogel treatment on quality of life via the EORTC QLQ-NET21 and the EORTC-QLQ-C30. The questionnaires will be conducted at enrolment, and at weeks 13, 25 and 53. Assessment of progression free survival at one year. Patients will undergo a CT or MRI scan at screening, week 25 and 53 within the local investigator site. Progression will be assessed using the RECIST criteria. Exploratory Secondary Efficacy Endpoints and Evaluations: To assess the effect of Somatuline Autogel on plasma chromogranin A, urinary and plasma 5-hydroxyindoleacetic acid (5-HIAA) and neurokinin A, and whether these biomarkers correlate with CTC numbers. To assess whether urinary 5-HIAA and plasma 5-HIAA levels are correlated. To investigate the genomic profile of CTCs at week 1 and at the time of any observed progression (RECIST evaluation at 25 and 53 weeks). To investigate the genomic profile of liver metastases at the time of any observed progression (RECIST evaluation at 25 and 53 weeks) in appropriate patients. To evaluate the presence and density of somatostatin receptor (SSTR) subtypes 2 and 5 on CTCs at weeks 1, 5, 25 and 53 of the study. To compare the SSTR2 and SSTR5 density on CTCs with patients’ clinical symptomatic response and progression free survival during Somatuline Autogel treatment. To compare the density of SSTR2 and SSTR5 on CTCs with that on primary tumour and liver metastasis in the patients where the primary tumour or liver metastasis samples are available. | — |
Countries
United Kingdom
Contacts
Public ContactAnne Fairey - UK Medical Director
Ipsen Limited
Outcome results
None listed