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

Endocrine Tumors Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353496
• Other study ID #: 2-55-52030-726
• Secondary ID: 2005-004904-35
• Status: Completed
• Phase: Phase 3
• Start date: June 2006
• Est. completion date: April 2013

Study information

• Verified date: September 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Endocrine Tumors

Intervention

Drug:
• lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
• Placebo
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Locations

Country	Name	City	State
Austria	University Hospital	Vienna
Belgium	UZ Antwerpen	Antwerpen
Belgium	UCL Saint Luc	Bruxelles
Belgium	UZ Gent	Gent
Czechia	Fakultni nemocnice Na	Bulovce	Prague
Czechia	Fekultni nemocnice Olomouc	Olomouc
Czechia	General faculty	Praha
Denmark	Sygehus Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
France	Hôpital A. Paré	Boulogne Billancourt
France	Hôpital Beaujon	Clichy
France	CAC Oscar Lambret	Lille
France	Hôpital Edouard Herriot	Lyon
France	CHU la Timone	Marseille
France	Hôpital R. Debré	Reims
France	CHI Frejus St Raphael	St Raphael
France	Hôpital Rangueil	Toulouse
France	Unité de gastro enterologie IGR	Villejuif
Germany	Charite Hospital	Berlin
Germany	University Hospital	Erlangen
Germany	University Hospital	Lubeck
Germany	Gutenberg University Hospital	Mainz
Germany	University Hospital	Munchen
Germany	Lukas Hospital	Neuss
India	Global Hospital	Hyderabad
India	Tata Memorial Hospital	Mumbai
Italy	Centro di Refierimiento Oncologica	Aviano
Italy	Azienda Malpighi	Bologna
Italy	INSCT	Milano
Italy	University of Naples	Naples
Italy	Hospital S. Chiara	Pisa
Italy	Azienda San Giovanni Battista	Torino
Netherlands	UMC Gronigen	Gronigen
Netherlands	Erasmu MC	Rotterdam
Netherlands	UMC Utrecht	Utrecht
Poland	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	Warszawa
Poland	Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego	Warszawa
Poland	Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie	Warszawa
Poland	Silesian Medical University	Zabrze
Slovakia	Narodny onkologicky ustav, Bratislava	Slovakia
Slovakia	Vychodoslovensky onkologicky ustav, Rastislavova	Slovakia
Spain	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	Tenerife
Sweden	Sahlgrenska Hospital	Goteborg
Sweden	Karolinska University Hospital	Stockholm
Sweden	University Hospital	Uppsala
United Kingdom	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 States	The John Hopkins Hospital	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Cedars-Sinai Outpatient Cancer Center	Los Angeles	California
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  Denmark,  France,  Germany,  India,  Italy,  Netherlands,  Poland,  Slovakia,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlácková 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 48 & 96
Secondary	Pharmacokinetic Profile of Lanreotide	Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints	Week 4, 12, 24, 36, 48, 72, 96
Secondary	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.	Week 12 to Week 96 (last visit)
Secondary	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)
Secondary	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.	Randomisation to death or last visit, up to 321 weeks