Extension study of Lanreotide Autogen 120mg in patients with a certain endocrine digestive tumour

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2008-004019-36-PL
• Date of registration: 17/06/2009
• Prospective Registration: Yes
• Primary sponsor: IPSEN PHARMA SAS
• Public title: Extension study of Lanreotide Autogen 120mg in patients with a certain endocrine digestive tumour
• Scientific title: Open label extension study of lanreotide Autogel 120 mg in patients with non functioning entero-pancreatic endocrine tumour. - Not applicable
• Date of first enrolment: 23/05/2013
• Target sample size: 89
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004019-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no 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 Number of treatment arms in the trial: 1

Countries of recruitment

Belgium, Czech Republic, France, India, Italy, Poland, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

• Name: VP Therapeutic Area Endocrinology
• Affiliation: Ipsen Pharma SAS

• Name: VP Therapeutic Area Endocrinology
• Affiliation: Ipsen Pharma SAS

Key inclusion & exclusion criteria

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).
or
? 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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Non functioning entero-pancreatic tumour
MedDRA version: 17.1 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Trade Name: SOMATULINE AUTOGEL 120 MG
Product Name: Lanreotide Autogel 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lanreotide
CAS Number: 127984-74-1
Other descriptive name: Lanreotide Actate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

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.

Primary end point(s): The primary criterion for the assessment of safety will be an investigation into the incidence of adverse events.

Timepoint(s) of evaluation of this end point: At the protocol defined timepoints.

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.

Secondary Outcome(s)

Secondary end point(s): • Vital signs
• Physical examination
• ECG
• Gallbladder echography
• Laboratory tests: standard haematology and biochemistry
• Concomitant medication

Timepoint(s) of evaluation of this end point: At the protocol defined timepoints

Secondary ID(s)

Protocol2-55-52030-729

2008-004019-36-FR

Source(s) of Monetary Support

Ipsen Pharma SAS