PHASE III, RANDOMISED, DOUBLE BLIND, STRATIFIED COMPARATIVE, PLACEBO CONTROLLED, PARALLEL GROUP, MULTICENTRE STUDY TO ASSESS THE EFFECT OF DEEP SUBCUTANEOUS INJECTIONS OF LANREOTIDE AUTOGEL 120 MG ADMINISTERED EVERY 28 DAYS ON TUMOUR PROGRESSION FREE SURVIVAL IN PATIENTS WITH NON FUNCTIONING ENTERO-PANCREATIC ENDOCRINE TUMOUR - ND

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2005-004904-35-IT
• Date of registration: 03/05/2007
• Prospective Registration: No
• Primary sponsor: BEAUFOUR IPSEN PHARMA
• Public title: PHASE III, RANDOMISED, DOUBLE BLIND, STRATIFIED COMPARATIVE, PLACEBO CONTROLLED, PARALLEL GROUP, MULTICENTRE STUDY TO ASSESS THE EFFECT OF DEEP SUBCUTANEOUS INJECTIONS OF LANREOTIDE AUTOGEL 120 MG ADMINISTERED EVERY 28 DAYS ON TUMOUR PROGRESSION FREE SURVIVAL IN PATIENTS WITH NON FUNCTIONING ENTERO-PANCREATIC ENDOCRINE TUMOUR - ND
• Scientific title: PHASE III, RANDOMISED, DOUBLE BLIND, STRATIFIED COMPARATIVE, PLACEBO CONTROLLED, PARALLEL GROUP, MULTICENTRE STUDY TO ASSESS THE EFFECT OF DEEP SUBCUTANEOUS INJECTIONS OF LANREOTIDE AUTOGEL 120 MG ADMINISTERED EVERY 28 DAYS ON TUMOUR PROGRESSION FREE SURVIVAL IN PATIENTS WITH NON FUNCTIONING ENTERO-PANCREATIC ENDOCRINE TUMOUR - ND
• Date of first enrolment: 08/11/2006
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004904-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Czech Republic, Denmark, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1) Has provided written informed consent prior to any study related procedures,

2) Is a male or a female of 18 years of age or older,

3) Has an entero-pancreatic endocrine tumour centrally confirmed by histological criteria,

4) Has metastatic disease and/or locally advanced inoperable tumour,

5) Has a tumour measurable according to RECIST criteria (central assessment),

6) Has no hormone related symptoms,

7) Has an entero-pancreatic endocrine tumour with the primary localisation in

pancreas, mid-gut or hind gut,

8) Has a well or moderately differentiated tumour (central assessment),

9) Has a tumour with proliferation index (Ki67) < 10% (central assessment),

10) Has a >= grade 2 octreoscan assessed using the Krenning scale, during the screening period or within 6 months prior to study entry (Visit 1) for the organ of target lesions,

11) 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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patient will not be included in the study if he/she :

1) Has been treated with a somatostatin analogue at any time prior to study entry(Visit 1), except if that treatment was for less than 15 days (e.g. peri-operatively)and the treatment was received more than 6 months before study entry (Visit 1),

2) Has been treated with radionuclide at any time prior to study entry (Visit 1),

3) Has been treated with interferon, chemoembolisation or chemotherapy within 6 months prior to study entry (Visit 1),

4) Has had a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intend and free from disease for more than 5 years),

5) Has a history of hypersensitivity to drugs with a similar chemical structure,

6) Has been treated with any other unlicensed drug within the last 30 days before study entry (Visit 1),

7) Is likely to require treatment during the study with drugs that are not permitted by the study protocol (see Section 9.6),

8) Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test at study entry (Visit 1) and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined

as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study,

9) 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,

10) Has abnormal baseline findings, 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,

11) Has been previously enrolled in this study,


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

PATIENTS WITH NON FUNCTIONING ENTERO-PANCREATIC ENDOCRINE TUMOUR
MedDRA version: 9.1 Level: LLT Classification code 10061121 Term: Endocrine neoplasm

Intervention(s)

Trade Name: IPSTYL*SC SIR 120MG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lanreotide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The primary study objective is to assess the effect of lanreotide

Autogel 120mg administered every 28 days compared to placebo, on

progression-free survival in patients with well or moderately

differentiated non functioning entero-pancreatic endocrine tumour.

The primary endpoint will be time to either disease progression

(measured using RECIST criteria) or death, within 96 weeks after

first treatment administration.

Secondary Objective: The secondary objectives are:

? To compare the proportion of patients alive and without

progression between both groups at 48 and 96 weeks,

? To compare time to progression in patients with progression between both groups,

? To assess the effect of lanreotide Autogel 120 mg compared to placebo on quality of life using EORTC QLQ-C30 and QLQGI.

NET21 questionnaires,

? To assess the effect of lanreotide Autogel 120 mg compared to placebo on plasma chromogranin A and on any other tumour peptide markers with elevated level at baseline (Visit 2),

? To assess the clinical and biological safety profile of lanreotide

Autogel 120 mg,

? To assess the putative appearance of lanreotide antibodies,

? To assess the pharmacokinetic profile of lanreotide Autogel 120 mg

Main Objective: The primary study objective is to assess the effect of lanreotide

Autogel 120mg administered every 28 days compared to placebo, on

progression-free survival in patients with well or moderately

differentiated non functioning entero-pancreatic endocrine tumour.

The primary endpoint will be time to either disease progression

(measured using RECIST criteria) or death, within 96 weeks after

first treatment administration.

Secondary ID(s)

2-55-52030-726

2005-004904-35-GB