search
Back to results

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours (CLARINET)

Primary Purpose

Endocrine Tumors

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lanreotide (Autogel formulation)
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endocrine Tumors focused on measuring Non functioning entero-pancreatic tumours

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Cedars-Sinai Outpatient Cancer Center
  • University of Iowa
  • The John Hopkins Hospital
  • Dana Farber Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Providence Portland Medical Center
  • MD Anderson Cancer Center
  • University of Wisconsin School of Medicine and Public Health
  • University Hospital
  • UZ Antwerpen
  • UCL Saint Luc
  • UZ Gent
  • Fakultni nemocnice Na
  • Fekultni nemocnice Olomouc
  • General faculty
  • Sygehus Hospital
  • Rigshospitalet
  • Hôpital A. Paré
  • Hôpital Beaujon
  • CAC Oscar Lambret
  • Hôpital Edouard Herriot
  • CHU la Timone
  • Hôpital R. Debré
  • CHI Frejus St Raphael
  • Hôpital Rangueil
  • Unité de gastro enterologie IGR
  • Charite Hospital
  • University Hospital
  • University Hospital
  • Gutenberg University Hospital
  • University Hospital
  • Lukas Hospital
  • Global Hospital
  • Tata Memorial Hospital
  • Centro di Refierimiento Oncologica
  • Azienda Malpighi
  • INSCT
  • University of Naples
  • Hospital S. Chiara
  • Azienda San Giovanni Battista
  • UMC Gronigen
  • Erasmu MC
  • UMC Utrecht
  • Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.
  • Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu
  • Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a
  • Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego
  • Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie
  • Silesian Medical University
  • Narodny onkologicky ustav, Bratislava
  • Vychodoslovensky onkologicky ustav, Rastislavova
  • Hospital Vall d'Hebron
  • Institut Catala Oncologia
  • Hospital G. Maranon
  • Hospital La Paz
  • Hospital Nuestra Senora de la Candelaria
  • Sahlgrenska Hospital
  • Karolinska University Hospital
  • University Hospital
  • Basingstoke and North Hampshire Hospital
  • Royal Victoria Hospital
  • University Hospital Wales
  • Western General Hospital
  • Beatson West of Scotland Cancer Centre
  • St James Hospital
  • Leicester Royal Infirmary
  • Royal Free Hospital
  • St Bartholomew's Hospital
  • QMC
  • Churchill Hospital
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lanreotide (Autogel formulation)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Pharmacokinetic Profile of Lanreotide
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
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.
Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels
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.

Full Information

First Posted
July 17, 2006
Last Updated
September 15, 2022
Sponsor
Ipsen
search

1. Study Identification

Unique Protocol Identification Number
NCT00353496
Brief Title
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
Acronym
CLARINET
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine Tumors
Keywords
Non functioning entero-pancreatic tumours

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lanreotide (Autogel formulation)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
lanreotide (Autogel formulation)
Intervention Description
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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
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
Secondary Outcome Measure Information:
Title
Percentage of Patients Alive & Without Disease Progression
Description
Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
Time Frame
Week 48 & 96
Title
Pharmacokinetic Profile of Lanreotide
Description
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
Time Frame
Week 4, 12, 24, 36, 48, 72, 96
Title
Change in the Global Health Status Quality of Life Assessment
Description
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.
Time Frame
Week 12 to Week 96 (last visit)
Title
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)
Title
Percentage of Patients Still Alive Based on Available Overall Survival Data
Description
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.
Time Frame
Randomisation to death or last visit, up to 321 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, Endocrinology
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Outpatient Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-4606
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-5666
Country
United States
Facility Name
University Hospital
City
Vienna
Country
Austria
Facility Name
UZ Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
UCL Saint Luc
City
Bruxelles
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Fakultni nemocnice Na
City
Bulovce
State/Province
Prague
Country
Czechia
Facility Name
Fekultni nemocnice Olomouc
City
Olomouc
Country
Czechia
Facility Name
General faculty
City
Praha
Country
Czechia
Facility Name
Sygehus Hospital
City
Aarhus
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hôpital A. Paré
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
CAC Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHU la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital R. Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHI Frejus St Raphael
City
St Raphael
ZIP/Postal Code
83300
Country
France
Facility Name
Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Unité de gastro enterologie IGR
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Charite Hospital
City
Berlin
Country
Germany
Facility Name
University Hospital
City
Erlangen
Country
Germany
Facility Name
University Hospital
City
Lubeck
Country
Germany
Facility Name
Gutenberg University Hospital
City
Mainz
Country
Germany
Facility Name
University Hospital
City
Munchen
Country
Germany
Facility Name
Lukas Hospital
City
Neuss
Country
Germany
Facility Name
Global Hospital
City
Hyderabad
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
Country
India
Facility Name
Centro di Refierimiento Oncologica
City
Aviano
Country
Italy
Facility Name
Azienda Malpighi
City
Bologna
Country
Italy
Facility Name
INSCT
City
Milano
Country
Italy
Facility Name
University of Naples
City
Naples
Country
Italy
Facility Name
Hospital S. Chiara
City
Pisa
Country
Italy
Facility Name
Azienda San Giovanni Battista
City
Torino
Country
Italy
Facility Name
UMC Gronigen
City
Gronigen
Country
Netherlands
Facility Name
Erasmu MC
City
Rotterdam
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.
City
Gliwice
Country
Poland
Facility Name
Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu
City
Poznan
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a
City
Warszawa
Country
Poland
Facility Name
Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego
City
Warszawa
Country
Poland
Facility Name
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie
City
Warszawa
Country
Poland
Facility Name
Silesian Medical University
City
Zabrze
Country
Poland
Facility Name
Narodny onkologicky ustav, Bratislava
City
Slovakia
Country
Slovakia
Facility Name
Vychodoslovensky onkologicky ustav, Rastislavova
City
Slovakia
Country
Slovakia
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Institut Catala Oncologia
City
Barcelona
Country
Spain
Facility Name
Hospital G. Maranon
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Nuestra Senora de la Candelaria
City
Tenerife
Country
Spain
Facility Name
Sahlgrenska Hospital
City
Goteborg
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
University Hospital
City
Uppsala
Country
Sweden
Facility Name
Basingstoke and North Hampshire Hospital
City
Basingstoke
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
Country
United Kingdom
Facility Name
University Hospital Wales
City
Cardiff
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
St James Hospital
City
Leeds
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
QMC
City
Nottingham
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/
Citations:
PubMed Identifier
25014687
Citation
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.
Results Reference
result
PubMed Identifier
33052555
Citation
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.
Results Reference
derived
PubMed Identifier
25408662
Citation
Lybaert 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.
Results Reference
derived

Learn more about this trial

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

We'll reach out to this number within 24 hrs