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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
First received
Last updated
Start date June 2006
Est. completion date April 2013

Study information

Verified date September 2022
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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