Phase III, randomised, double-blind, stratified comparative, placebo controlled, parallel group, multicenter 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. - Not applicable

Phase 1

• Conditions: on functioning entero-pancreatic tumours; MedDRA version: 8.0Level: PTClassification code 10052399

• Registration Number: EUCTR2005-004904-35-GR
• Lead Sponsor: IPSEN Research and Development, BEAUFOUR IPSEN PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-24
• Study Completion: 2013-04-09
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1) Provision of written informed consent prior to any study related procedures,
2) Male or female of 18 years of age or older,
3) Has an entero-pancreatic endocrine tumour centrally confirmed by histological criteria,
4) Has a metastatic disease and/or an 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 hint 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
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

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 a 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 intent and free from disease for more than 5 years),
5) Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test wat study entry (visit 1) 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 three months before the start of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified