Clinical trial NCT00842348: Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour
Official title: Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Functioning Entero-pancreatic Endocrine Tumour
Keywords: Lanreotide
Somatuline
Neuroendocrine tumour
NET
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Adverse Events
timeFrame: Throughout the study until the completion/early discontinuation visit.
Secondary outcomes:
measure: Progression Free Survival (PFS): Kaplan-Meier Estimate
timeFrame: Throughout the study (every 24 weeks and at completion/withdrawal visit)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Outpatient Cancer Center
state: California
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Bruxelles
country: Belgium
facility: UCL Saint Luc
city: Prague
country: Czechia
facility: Fakultni nemocnice Na Bulovce
city: Praha
country: Czechia
facility: General faculty
city: Clichy
country: France
facility: Hôpital Beaujon
city: Lille
country: France
facility: CAC Oscar Lambret
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Reims
country: France
facility: Hôpital R. Debré
city: Aviano
country: Italy
facility: Centro di Refierimiento Oncologica
city: Milano
country: Italy
facility: INSCT
city: Naples
country: Italy
facility: University of Naples
city: Torino
country: Italy
facility: Azienda San Giovanni Battista
city: Warszawa
country: Poland
facility: Centrum Diagnostyczno-Lecznicze "Gammed"
city: Warszawa
country: Poland
facility: Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Catala Oncologia
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: St James Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Nottingham
country: United Kingdom
facility: QMC
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.