Non Functioning Entero-pancreatic Endocrine TumourPhase 3NET729NCT00842348

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

A Phase 3 study testing lanreotide (Autogel formulation) in people with Non Functioning Entero-pancreatic Endocrine Tumour, run by Ipsen at 25 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Functioning Entero-pancreatic Endocrine Tumour
What is being tested?: lanreotide (Autogel formulation)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 25 sitesin 9 countries
Study dates: Feb 2009to Dec 2015
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

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

25 sites in 9 countries.

Country

City, postcode or hospital

25 sites in 9 countries

United Kingdom6 sites

University Hospital Wales
Cardiff
Western General Hospital
Edinburgh
Beatson West of Scotland Cancer Centre
Glasgow
St James Hospital
Leeds
Royal Free Hospital
London
QMC
Nottingham

Other trials in United Kingdom

France4 sites

Hôpital Beaujon
Clichy, 92118
CAC Oscar Lambret
Lille, 59020
Hôpital Edouard Herriot
Lyon, 69437
Hôpital R. Debré
Reims, 51092

Other trials in France

Italy4 sites

Centro di Refierimiento Oncologica
Aviano
INSCT
Milan
University of Naples
Naples
Azienda San Giovanni Battista
Torino

Other trials in Italy

United States2 sites

The Johns Hopkins Hospital
Baltimore, Maryland, 21287-4606
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, 90048

Other trials in United States

Belgium2 sites

UZ Antwerpen
Antwerp
UCL Saint Luc
Brussels

Other trials in Belgium

Czechia2 sites

Fakultni nemocnice Na Bulovce
Prague
General faculty
Prague

Other trials in Czechia

Poland2 sites

Centrum Diagnostyczno-Lecznicze "Gammed"
Warsaw
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny
Warsaw

Other trials in Poland

Spain2 sites

Hospital Vall d'Hebron
Barcelona
Institut Catala Oncologia
Barcelona

Other trials in Spain

Slovakia1 site

Narodny onkologicky ustav
Bratislava

Other trials in Slovakia

About this study

Official title: Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

Read the 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).

Conditions: Non Functioning Entero-pancreatic Endocrine Tumour
Being tested: lanreotide (Autogel formulation)
Keywords: Lanreotide, Somatuline, Neuroendocrine tumour, NET
Medical subject headings: Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lanreotide (Autogel formulation)Drug
Also called Lanreotide, Lanreotide Autogel, Somatuline, Somatuline Autogel
Autogel 120 mg

Study groups in NCT00842348
Study group	Role	What they receive
Lanreotide (Autogel formulation)	Experimental	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). Receives: Drug: lanreotide (Autogel formulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Throughout the study until the completion/early discontinuation visit.

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Dec 2015

First posted12 Feb 2009 (estimated)
Study startFeb 2009
Primary completionDec 2015
Study completionDec 2015

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 (2)Papers the sponsor has linked to this study.
Other trials for Non Functioning Entero-pancreatic Endocrine TumourStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00842348
Sponsor's protocol ID: 2-55-52030-729
Other IDs: 2008-004019-36, 2008
Acronym: NET729
Status last verified: Sep 2022
First submitted: 11 Feb 2009
Last updated: 12 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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, 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.
PubMed 26743120
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.
PubMed 33052555

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
ClinicalTrials.gov ID: NCT00842348
Acronym / sponsor ID: NET729 / 2-55-52030-729
Conditions: Non Functioning Entero-pancreatic Endocrine Tumour
Keywords: Lanreotide, Somatuline, Neuroendocrine tumour, NET
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 12 Feb 2009 (estimated)
Results: Posted 17 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lanreotide (Autogel formulation)	Experimental	Drug: 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Had provided written informed consent prior to any study-related procedures.
Had been enrolled and treated in Study 2-55-52030-726 and either:
Had a World Health Organisation (WHO) performance score lower than or equal to 2.

Key exclusion criteria (10 listed)

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.

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)Also: Lanreotide, Lanreotide Autogel, Somatuline, Somatuline AutogelAutogel 120 mg	Drug	Lanreotide (Autogel formulation)

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 17 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanreotide Autogel	101	42
Placebo	103	47

Primary outcome: Adverse Events

Time frame: Throughout the study until the completion/early discontinuation visit.. Number. Unit: participants with any TEAEs

Measure	Lanreotide Autogel n = 42	Placebo n = 47	Total n = 89
Value	40	46	86

Population analysed: Safety population: all patients who received at least one dose of lanreotide Autogel in Study 729.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored from the time that the patient withdrew or completed Study 726 until withdrawal in Study 729.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanreotide Autogel	11 of 42 (26.2%)	34 of 42 (81%)	Not reported
Placebo	14 of 47 (29.8%)	42 of 47 (89.4%)	Not reported
Total	25 of 89 (28.1%)	76 of 89 (85.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26743120Caplin 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.
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.
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.

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.

Ipsen Medical Director study director

Ipsen

25 sites in 9 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 Non Functioning Entero-pancreatic Endocrine Tumour, run by Ipsen at 25 sites in 9 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 5 inclusion and 10 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United Kingdom, France, Italy, United States, Belgium and 4 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. 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 17 Feb 2017). 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?

Adverse Events (time frame: Throughout the study until the completion/early discontinuation visit.). 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 NCT00842348, which also lists 2 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 12 Oct 2022.