Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour
NET729
Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
2 other identifiers
interventional
89
9 countries
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2009
Longer than P75 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 11, 2009
CompletedFirst Posted
Study publicly available on registry
February 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
February 17, 2017
CompletedOctober 12, 2022
September 1, 2022
6.8 years
February 11, 2009
December 28, 2016
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
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.
Throughout the study until the completion/early discontinuation visit.
Secondary Outcomes (1)
Progression Free Survival (PFS): Kaplan-Meier Estimate
Throughout the study (every 24 weeks and at completion/withdrawal visit)
Study Arms (1)
Lanreotide (Autogel formulation)
EXPERIMENTALPatients 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).
Interventions
Autogel 120 mg
Eligibility Criteria
You may qualify if:
- Had provided written informed consent prior to any study-related procedures.
- 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.
- Had a World Health Organisation (WHO) performance score lower than or equal to 2.
You may not qualify if:
- 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.
- Had received any new treatment for the entero-pancreatic NET since the end of participation in the study.
- Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET.
- Had been treated with radionuclide at any time prior to study entry.
- Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg.
- Were likely to require treatment during the study with drugs that were not permitted by the study protocol.
- 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.
- 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.
- 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.
- Previous enrolment in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (25)
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287-4606, United States
UZ Antwerpen
Antwerp, Belgium
UCL Saint Luc
Brussels, Belgium
Fakultni nemocnice Na Bulovce
Prague, Czechia
General faculty
Prague, Czechia
Hôpital Beaujon
Clichy, 92118, France
CAC Oscar Lambret
Lille, 59020, France
Hôpital Edouard Herriot
Lyon, 69437, France
Hôpital R. Debré
Reims, 51092, 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
Related Publications (2)
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.
PMID: 26743120RESULTCaplin 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.
PMID: 33052555DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Oncology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2009
First Posted
February 12, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
October 12, 2022
Results First Posted
February 17, 2017
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.