Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
CLARINET
Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
2 other identifiers
interventional
264
15 countries
71
Brief Summary
The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2006
Longer than P75 for phase_3
71 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
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 17, 2006
CompletedFirst Posted
Study publicly available on registry
July 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
February 18, 2015
CompletedMarch 5, 2025
February 1, 2025
6.8 years
July 17, 2006
January 15, 2015
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0
From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year
Secondary Outcomes (5)
Percentage of Patients Alive & Without Disease Progression
Week 48 & 96
Pharmacokinetic Profile of Lanreotide
Week 4, 12, 24, 36, 48, 72, 96
Change in the Global Health Status Quality of Life Assessment
Week 12 to Week 96 (last visit)
Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels
Week 12 to Week 96 (last visit)
Percentage of Patients Still Alive Based on Available Overall Survival Data
Randomisation to death or last visit, up to 321 weeks
Study Arms (2)
lanreotide (Autogel formulation)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Eligibility Criteria
You may qualify if:
- Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease
- No hormone related symptoms
- Well or moderately differentiated tumour confirmed by histology
- Tumour lesions which are measurable by a CT or MRI scan
You may not qualify if:
- Previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days
- Treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide
- Had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for 5 years
- Pregnant or lactating
- Females must use adequate contraception during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (71)
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048, United States
University of Iowa
Iowa City, Iowa, 52242, United States
The John Hopkins Hospital
Baltimore, Maryland, 21287-4606, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792-5666, United States
University Hospital
Vienna, Austria
UZ Antwerpen
Antwerp, Belgium
UCL Saint Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
Fakultni nemocnice Na
Bulovce, Prague, Czechia
Fekultni nemocnice Olomouc
Olomouc, Czechia
General faculty
Prague, Czechia
Sygehus Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Hôpital A. Paré
Boulogne-Billancourt, 92100, France
HĂ´pital Beaujon
Clichy, 92118, France
CAC Oscar Lambret
Lille, 59020, France
HĂ´pital Edouard Herriot
Lyon, 69437, France
CHU la Timone
Marseille, 13385, France
Hôpital R. Debré
Reims, 51092, France
CHI Frejus St Raphael
Saint-Raphaël, 83300, France
HĂ´pital Rangueil
Toulouse, 31059, France
Unité de gastro enterologie IGR
Villejuif, 94805, France
Charite Hospital
Berlin, Germany
University Hospital
Erlangen, Germany
University Hospital
LĂ¼beck, Germany
Gutenberg University Hospital
Mainz, Germany
University Hospital
MĂ¼nchen, Germany
Lukas Hospital
Neuss, Germany
Global Hospital
Hyderabad, India
Tata Memorial Hospital
Mumbai, India
Centro di Refierimiento Oncologica
Aviano, Italy
Azienda Malpighi
Bologna, Italy
INSCT
Milan, Italy
University of Naples
Naples, Italy
Hospital S. Chiara
Pisa, Italy
Azienda San Giovanni Battista
Torino, Italy
UMC Gronigen
Gronigen, Netherlands
Erasmu MC
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.
Gliwice, Poland
Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu
Poznan, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a
Warsaw, Poland
Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego
Warsaw, Poland
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie
Warsaw, Poland
Silesian Medical University
Zabrze, Poland
Narodny onkologicky ustav, Bratislava
Slovakia, Slovakia
Vychodoslovensky onkologicky ustav, Rastislavova
Slovakia, Slovakia
Hospital Vall d'Hebron
Barcelona, Spain
Institut Catala Oncologia
Barcelona, Spain
Hospital G. Maranon
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Nuestra Senora de la Candelaria
Santa Cruz de Tenerife, Spain
Sahlgrenska Hospital
Gothenburg, Sweden
Karolinska University Hospital
Stockholm, Sweden
University Hospital
Uppsala, Sweden
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom
Royal Victoria Hospital
Belfast, 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
Leicester Royal Infirmary
Leicester, United Kingdom
Royal Free Hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
QMC
Nottingham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Related Publications (3)
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, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
PMID: 25014687RESULTCaplin 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: 33052555DERIVEDLybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel((R)): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep.
PMID: 25408662DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Medical Director Endocrinology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Medical Director, Endocrinology
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2006
First Posted
July 18, 2006
Study Start
June 1, 2006
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
March 5, 2025
Results First Posted
February 18, 2015
Record last verified: 2025-02
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.