Endocrine TumorsPhase 3CLARINETNCT00353496
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
A Phase 3 study testing lanreotide (Autogel formulation) in people with Endocrine Tumors, run by Ipsen at 71 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine Tumors
- What is being tested?
- lanreotide (Autogel formulation)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 71 sitesin 15 countries
- Study dates
- Jun 2006to Apr 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
71 sites in 15 countries.
71 sites in 15 countries
United Kingdom12 sites
Basingstoke and North Hampshire Hospital
Basingstoke
Royal Victoria Hospital
Belfast
University Hospital Wales
Cardiff
Western General Hospital
Edinburgh
Beatson West of Scotland Cancer Centre
Glasgow
St James Hospital
Leeds
Leicester Royal Infirmary
Leicester
Royal Free Hospital
London
St Bartholomew's Hospital
London
QMC
Nottingham
Churchill Hospital
Oxford
Royal Hallamshire Hospital
Sheffield
France9 sites
Hôpital A. Paré
Boulogne-Billancourt, 92100
Hôpital Beaujon
Clichy, 92118
CAC Oscar Lambret
Lille, 59020
Hôpital Edouard Herriot
Lyon, 69437
CHU la Timone
Marseille, 13385
Hôpital R. Debré
Reims, 51092
CHI Frejus St Raphael
Saint-Raphaël, 83300
Hôpital Rangueil
Toulouse, 31059
Unité de gastro enterologie IGR
Villejuif, 94805
United States8 sites
The John Hopkins Hospital
Baltimore, Maryland, 21287-4606
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
MD Anderson Cancer Center
Houston, Texas, 77030-4009
University of Iowa
Iowa City, Iowa, 52242
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792-5666
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Providence Portland Medical Center
Portland, Oregon, 97213
Germany6 sites
Charite Hospital
Berlin
University Hospital
Erlangen
University Hospital
Lübeck
Gutenberg University Hospital
Mainz
University Hospital
München
Lukas Hospital
Neuss
Italy6 sites
Centro di Refierimiento Oncologica
Aviano
Azienda Malpighi
Bologna
INSCT
Milan
University of Naples
Naples
Hospital S. Chiara
Pisa
Azienda San Giovanni Battista
Torino
Poland6 sites
Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.
Gliwice
Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu
Poznan
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a
Warsaw
Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego
Warsaw
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie
Warsaw
Silesian Medical University
Zabrze
Spain5 sites
Hospital Vall d'Hebron
Barcelona
Institut Catala Oncologia
Barcelona
Hospital G. Maranon
Madrid
Hospital La Paz
Madrid
Hospital Nuestra Senora de la Candelaria
Santa Cruz de Tenerife
Czechia3 sites
Fakultni nemocnice Na
Bulovce, Prague
Fekultni nemocnice Olomouc
Olomouc
General faculty
Prague
Netherlands3 sites
UMC Gronigen
Gronigen
Erasmu MC
Rotterdam
UMC Utrecht
Utrecht
Sweden3 sites
Sahlgrenska Hospital
Gothenburg
Karolinska University Hospital
Stockholm
University Hospital
Uppsala
Slovakia2 sites
Narodny onkologicky ustav, Bratislava
Slovakia
Vychodoslovensky onkologicky ustav, Rastislavova
Slovakia
About this study
Official title: 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
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.
- Conditions
- Endocrine Tumors
- Being tested
- lanreotide (Autogel formulation), Placebo
- Keywords
- Non functioning entero-pancreatic tumours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lanreotide (Autogel formulation)Drug
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
PlaceboDrug
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
| Study group | Role | What they receive |
|---|---|---|
| lanreotide (Autogel formulation) | Experimental | Not described Receives: Drug: lanreotide (Autogel formulation) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
Measured: Week 48 & 96
Pharmacokinetic Profile of Lanreotide
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
Measured: Week 4, 12, 24, 36, 48, 72, 96
Change in the Global Health Status Quality of Life Assessment
Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
Measured: 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
Measured: Week 12 to Week 96 (last visit)
Percentage of Patients Still Alive Based on Available Overall Survival Data
Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.
Measured: Randomisation to death or last visit, up to 321 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Endocrinology, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353496
- Sponsor's protocol ID
- 2-55-52030-726
- Other IDs
- 2005-004904-35, 2005
- Acronym
- CLARINET
- Status last verified
- Feb 2025
- First submitted
- 17 Jul 2006
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25014687Caplin 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.
PubMed 33052555Lybaert 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.
PubMed 25408662
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00353496
- Acronym / sponsor ID
- CLARINET / 2-55-52030-726
- Conditions
- Endocrine Tumors
- Keywords
- Non functioning entero-pancreatic tumours
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Jul 2006 (estimated)
- Results
- Posted 18 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lanreotide (Autogel formulation) | Experimental | Drug: lanreotide (Autogel formulation) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lanreotide (Autogel formulation)120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. | Drug | lanreotide (Autogel formulation) |
| PlaceboSaline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. | Drug | Placebo |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 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
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
5 secondary outcomes
Percentage of Patients Alive & Without Disease Progression
Time frame: Week 48 & 96
Pharmacokinetic Profile of Lanreotide
Time frame: Week 4, 12, 24, 36, 48, 72, 96
Change in the Global Health Status Quality of Life Assessment
Time frame: 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
Time frame: Week 12 to Week 96 (last visit)
Percentage of Patients Still Alive Based on Available Overall Survival Data
Time frame: Randomisation to death or last visit, up to 321 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25014687Caplin 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.
- Derived from this study: PubMed 33052555Caplin 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.
- Derived from this study: PubMed 25408662Lybaert 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director, Endocrinology study director
Ipsen
71 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lanreotide (Autogel formulation) in people with Endocrine Tumors, run by Ipsen at 71 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United Kingdom, France, United States, Germany, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353496, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.