Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour

NCT ID: NCT00842348

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2015-12-31

Brief Summary

The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).

Detailed Description

While somatostatin analogue treatment is the primary medical therapy for patients with hormone related symptoms and is indicated for the treatment of hormone related symptoms in many international countries, there is no reference standard medical therapy for asymptomatic patients. A 96-week study (Study 2-55-52030-726 (726), NCT00353496) was conducted to investigate the effect of lanreotide Autogel on progression free survival (PFS) in patients with well or moderately differentiated nonfunctioning enteropancreatic NET. While Study 726 was ongoing, the sponsor considered that therapy with lanreotide Autogel should continue to be an option to patients with stable disease at the end of the 96-week treatment period. This extension study was therefore initiated (Study 2-55-52030-729 (729)) which investigated the long term safety of treatment with lanreotide Autogel and enabled investigators to continue to treat their patients who had stable disease, as well as to treat placebo patients who experienced disease progression during the initial 96-week study (Study 726).

Conditions

Non Functioning Entero-pancreatic Endocrine Tumour

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lanreotide (Autogel formulation)

Patients from the preceding DB study (Study 726) were treated with open label lanreotide Autogel 120 mg by deep subcutaneous injections every 28 days. Patients were included if they had been treated with lanreotide (Autogel formulation) or placebo in DB Study 726 and had stable disease at the end of the 96-week treatment period, or if they had received placebo and had disease progression at any time during Study 726. Safety data were based on the safety population patients who received lanreotide in Study 729). The main efficacy analysis was based on the ITT population (patients randomised in Study 726 regardless of whether they continued into Study 729).

Group Type: EXPERIMENTAL

lanreotide (Autogel formulation)

Intervention Type: DRUG

Autogel 120 mg

Interventions

lanreotide (Autogel formulation)

Autogel 120 mg

Intervention Type: DRUG

Other Intervention Names

Lanreotide; Lanreotide Autogel; Somatuline; Somatuline Autogel; Somatuline Depot

Eligibility Criteria

Inclusion Criteria

1. Had provided written informed consent prior to any study-related procedures.

2. Had been enrolled and treated in Study 2-55-52030-726 and either:

• Was stable at 96 weeks of treatment (whatever the treatment received during the 2 years of participation, i.e. no code break at Week 96); or,
• Had received at least one injection in Study 2-55-52030-726 and had disease progression, confirmed by central assessment, during the course of the study and code break showed placebo.

3. Had a World Health Organisation (WHO) performance score lower than or equal to 2.

Exclusion Criteria

1. Had been enrolled and treated in the frame of the protocol and had disease progression during the study and the code break showed a treatment with lanreotide Autogel 120 mg.

2. Had received any new treatment for the entero-pancreatic NET since the end of participation in the study.

3. Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET.

4. Had been treated with radionuclide at any time prior to study entry.

5. Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg.

6. Were likely to require treatment during the study with drugs that were not permitted by the study protocol.

7. Were at risk of pregnancy or lactation. Females of childbearing potential had to provide a negative pregnancy test at the start of study and had to be using oral, double barrier or injectable contraception. Non-childbearing potential was defined as postmenopause for at least 1 year, or surgical sterilisation or hysterectomy at least 3 months before the start of the study.

8. Had 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.

9. Had abnormal findings at Visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might have jeopardised the patient's safety or decreased the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

10. Previous enrolment in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Cedars-Sinai Outpatient Cancer Center

Los Angeles, California, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

UZ Antwerpen

Antwerp, , Belgium

UCL Saint Luc

Brussels, , Belgium

Fakultni nemocnice Na Bulovce

Prague, , Czechia

General faculty

Prague, , Czechia

Hôpital Beaujon

Clichy, , France

CAC Oscar Lambret

Lille, , France

Hôpital Edouard Herriot

Lyon, , France

Hôpital R. Debré

Reims, , France

Centro di Refierimiento Oncologica

Aviano, , Italy

INSCT

Milan, , Italy

University of Naples

Naples, , Italy

Azienda San Giovanni Battista

Torino, , Italy

Centrum Diagnostyczno-Lecznicze "Gammed"

Warsaw, , Poland

Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny

Warsaw, , Poland

Narodny onkologicky ustav

Bratislava, , Slovakia

Hospital Vall d'Hebron

Barcelona, , Spain

Institut Catala Oncologia

Barcelona, , Spain

University Hospital Wales

Cardiff, , United Kingdom

Western General Hospital

Edinburgh, , United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

St James Hospital

Leeds, , United Kingdom

Royal Free Hospital

London, , United Kingdom

QMC

Nottingham, , United Kingdom

Countries

United States; Belgium; Czechia; France; Italy; Poland; Slovakia; Spain; United Kingdom

References

Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Gomez-Panzani E, Ruszniewski P; CLARINET Investigators. Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study. Endocr Relat Cancer. 2016 Mar;23(3):191-9. doi: 10.1530/ERC-15-0490. Epub 2016 Jan 7.

Reference Type: RESULT

PMID: 26743120 (View on PubMed)

Caplin ME, Pavel M, Phan AT, Cwikla JB, Sedlackova E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.

Reference Type: DERIVED

PMID: 33052555 (View on PubMed)

Other Identifiers

2008-004019-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2-55-52030-729

Identifier Type: -

Identifier Source: org_study_id