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

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ClinicalTrials.gov Identifier: NCT00353496
Recruitment Status : Completed
First Posted : July 18, 2006
Results First Posted : February 18, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment Phase
Endocrine Tumors Drug: lanreotide (Autogel formulation) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2006
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013


Arm Intervention/treatment
Experimental: lanreotide (Autogel formulation) Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Placebo Comparator: Placebo Drug: Placebo
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of Patients Alive & Without Disease Progression [ Time Frame: Week 48 & 96 ]
    Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.

  2. Pharmacokinetic Profile of Lanreotide [ Time Frame: Week 4, 12, 24, 36, 48, 72, 96 ]
    Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints

  3. Change in the Global Health Status Quality of Life Assessment [ Time Frame: Week 12 to Week 96 (last visit) ]
    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.

  4. 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) ]
  5. Percentage of Patients Still Alive Based on Available Overall Survival Data [ Time Frame: Randomisation to death or last visit, up to 321 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353496


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Locations
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United States, California
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
The John Hopkins Hospital
Baltimore, Maryland, United States, 21287-4606
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792-5666
Austria
University Hospital
Vienna, Austria
Belgium
UZ Antwerpen
Antwerpen, Belgium
UCL Saint Luc
Bruxelles, Belgium
UZ Gent
Gent, Belgium
Czech Republic
Fakultni nemocnice Na
Bulovce, Prague, Czech Republic
Fekultni nemocnice Olomouc
Olomouc, Czech Republic
General faculty
Praha, Czech Republic
Denmark
Sygehus Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
France
Hôpital A. Paré
Boulogne Billancourt, France, 92100
Hôpital Beaujon
Clichy, France, 92118
CAC Oscar Lambret
Lille, France, 59020
Hôpital Edouard Herriot
Lyon, France, 69437
CHU la Timone
Marseille, France, 13385
Hôpital R. Debré
Reims, France, 51092
CHI Frejus St Raphael
St Raphael, France, 83300
Hôpital Rangueil
Toulouse, France, 31059
Unité de gastro enterologie IGR
Villejuif, France, 94805
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, Germany
India
Global Hospital
Hyderabad, India
Tata Memorial Hospital
Mumbai, India
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, Italy
Netherlands
UMC Gronigen
Gronigen, Netherlands
Erasmu MC
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
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, Poland
Slovakia
Narodny onkologicky ustav, Bratislava
Slovakia, Slovakia
Vychodoslovensky onkologicky ustav, Rastislavova
Slovakia, 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, Spain
Sweden
Sahlgrenska Hospital
Goteborg, Sweden
Karolinska University Hospital
Stockholm, Sweden
University Hospital
Uppsala, Sweden
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 Kingdom
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Medical Director, Endocrinology Ipsen

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00353496     History of Changes
Other Study ID Numbers: 2-55-52030-726
2005-004904-35 ( EudraCT Number )
First Posted: July 18, 2006    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: March 6, 2015
Last Verified: February 2015
Keywords provided by Ipsen:
Non functioning entero-pancreatic tumours
Additional relevant MeSH terms:
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Endocrine Gland Neoplasms
Neoplasms
Neoplasms by Site
Endocrine System Diseases
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs