Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour (NET729)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Non Functioning Entero-pancreatic Endocrine Tumour	Drug: lanreotide (Autogel formulation)	Phase 3

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).

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	89 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
Study Start Date :	February 2009
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm

Intervention/treatment

Experimental: 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).

Drug: lanreotide (Autogel formulation); Autogel 120 mg; Other Names: Lanreotide; Lanreotide Autogel; Somatuline; Somatuline Autogel; Somatuline Depot

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Adverse Events [ Time Frame: Throughout the study until the completion/early discontinuation visit. ]

   Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.

   An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:

   • It was not present prior to receiving the first dose of study treatment in Study 729; or,
   • It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.

   Adverse event data are presented in the AE section.

Secondary Outcome Measures :

1. Progression Free Survival (PFS): Kaplan-Meier Estimate [ Time Frame: Throughout the study (every 24 weeks and at completion/withdrawal visit) ]

   The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours [RECIST] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.

   Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287-4606
Belgium
UZ Antwerpen
Antwerpen, Belgium
UCL Saint Luc
Bruxelles, Belgium
Czech Republic
Fakultni nemocnice Na Bulovce
Prague, Czech Republic
General faculty
Praha, Czech Republic
France
Hôpital Beaujon
Clichy, France, 92118
CAC Oscar Lambret
Lille, France, 59020
Hôpital Edouard Herriot
Lyon, France, 69437
Hôpital R. Debré
Reims, France, 51092
Italy
Centro di Refierimiento Oncologica
Aviano, Italy
INSCT
Milano, Italy
University of Naples
Naples, Italy
Azienda San Giovanni Battista
Torino, Italy
Poland
Centrum Diagnostyczno-Lecznicze "Gammed"
Warszawa, Poland
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny
Warszawa, Poland
Slovakia
Narodny onkologicky ustav
Bratislava, Slovakia
Spain
Hospital Vall d'Hebron
Barcelona, Spain
Institut Catala Oncologia
Barcelona, Spain
United Kingdom
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

Sponsors and Collaborators

Ipsen

Investigators

Study Director:	Douglas Fleming	Ipsen

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková 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.

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT00842348 History of Changes
Other Study ID Numbers:	2-55-52030-729; 2008-004019-36 ( EudraCT Number )
First Posted:	February 12, 2009
Results First Posted:	February 17, 2017
Last Update Posted:	February 17, 2017
Last Verified:	December 2016

Keywords provided by Ipsen:

Lanreotide; Somatuline; Neuroendocrine tumour; NET

Additional relevant MeSH terms:

Endocrine Gland Neoplasms; Adenoma, Islet Cell; Neoplasms by Site; Neoplasms; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatic Neoplasms; Digestive System Neoplasms	Digestive System Diseases; Pancreatic Diseases; Lanreotide; Angiopeptin; Somatostatin; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs