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

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00353496

Purpose

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	Intervention	Phase
Endocrine Tumors	Drug: lanreotide (Autogel formulation) Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Time to either disease progression or death [ Time Frame: Within 96 weeks after the first study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients alive & without progression [ Time Frame: Week 48 & 96 ] [ Designated as safety issue: No ]
Side effects [ Time Frame: For the duration of the study ] [ Designated as safety issue: Yes ]
Pharmacokinetic profile of lanreotide [ Time Frame: Week 1,4, 12, 20, 24, 36, 48, 72, 96 ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: At every visit (excluding screening) ] [ Designated as safety issue: No ]
Tumour markers [ Time Frame: At every visit (excluding screening) ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: lanreotide (Autogel formulation) 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
2: Placebo Comparator	Other: Placebo Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353496

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Hide Study Locations

Locations

United States, California
Ceders-Sinai Outpatient Cancer Center	Recruiting
Los Angeles, California, United States, 90048
United States, Iowa
University of Iowa	Terminated
Iowa City, Iowa, United States, 52242
United States, Maryland
The John Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21287-4606
United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
United States, Oregon
Providence Portland Medical Center	Recruiting
Portland, Oregon, United States, 97213
United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030-4009
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health	Not yet recruiting
Madison, Wisconsin, United States, 53792-5666
Austria
University Hospital	Recruiting
Vienna, Austria
Belgium
UZ Gent	Terminated
Gent, Belgium
UZ Antwerpen	Recruiting
Antwerpen, Belgium
UCL Saint Luc	Recruiting
Bruxelles, Belgium
Czech Republic
General faculty	Recruiting
Praha, Czech Republic
Fekultni nemocnice Olomouc	Recruiting
Olomouc, Czech Republic
Czech Republic, Prague
Fakultni nemocnice Na	Recruiting
Bulovce, Prague, Czech Republic
Denmark
Sygehus Hospital	Recruiting
Aarhus, Denmark
Rigshospitalet	Terminated
Copenhagen, Denmark
France
Hôpital Beaujon	Recruiting
Clichy, France, 92118
Hôpital A. Paré	Recruiting
Boulogne Billancourt, France, 92100
Unité de gastro enterologie	Recruiting
Villejuif, France, 94805
Hôpital Edouard Herriot	Recruiting
Lyon, France, 69437
CAC Oscar Lambret	Recruiting
Lille, France, 59020
CHU la Timone	Recruiting
Marseille, France, 13385
Hôpital R. Debré	Recruiting
Reims, France, 51092
Hôpital Rangueil	Recruiting
Toulouse, France, 31059
Germany
Charite Hospital	Recruiting
Berlin, Germany
Gutenberg University Hospital	Recruiting
Mainz, Germany
University Hospital	Recruiting
Erlangen, Germany
University Hospital	Terminated
Munchen, Germany
Lukas Hospital	Terminated
Neuss, Germany
University Hospital	Recruiting
Lubeck, Germany
Italy
INSCT	Recruiting
Milano, Italy
Azienda San Giovanni Battista	Recruiting
Torino, Italy
Centro di Refierimiento Oncologica	Recruiting
Aviano, Italy
Azienda Malpighi	Recruiting
Bologna, Italy
Hospital S. Chiara	Terminated
Pisa, Italy
University of Naples	Recruiting
Naples, Italy
Netherlands
Erasmu MC	Terminated
Rotterdam, Netherlands
UMC Gronigen	Terminated
Gronigen, Netherlands
UMC Utrecht	Terminated
Utrecht, Netherlands
Poland
Silesian Medical University	Recruiting
Zabrze, Poland
Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu	Recruiting
Poznan, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.	Recruiting
Gliwice, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a	Recruiting
Warszawa, Poland
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie	Recruiting
Warszawa, Poland
Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego	Not yet recruiting
Warszawa, Poland
Slovakia
Vychodoslovensky onkologicky ustav, Rastislavova	Recruiting
Slovakia, Slovakia
Narodny onkologicky ustav, Bratislava	Terminated
Slovakia, Slovakia
Spain
Hospital Vall d'Hebron	Recruiting
Barcelona, Spain
Institut Catala Oncologia	Recruiting
Barcelona, Spain
Hospital G. Maranon	Terminated
Madrid, Spain
Hospital La Paz	Terminated
Madrid, Spain
Hospital Nuestra Senora de la Candelaria	Recruiting
Tenerife, Spain
Sweden
University Hospital	Terminated
Uppsala, Sweden
Sahlgrenska Hospital	Terminated
Goteborg, Sweden
United Kingdom
Royal Free Hospital	Recruiting
London, United Kingdom
Western General Hospital	Recruiting
Edinburgh, United Kingdom
Western Infirmary	Recruiting
Glasgow, United Kingdom
St Bartholomew's Hospital	Recruiting
London, United Kingdom
QMC	Recruiting
Nottingham, United Kingdom
Royal Victoria Infirmary	Terminated
Newcastle, United Kingdom
Leicester Royal Infirmary	Recruiting
Leicester, United Kingdom
University Hospital Wales	Recruiting
Cardiff, United Kingdom
Royal Victoria Hospital	Recruiting
Belfast, United Kingdom
Cookridge Hospital	Recruiting
Leeds, United Kingdom
Churchill Hospital	Not yet recruiting
Oxford, United Kingdom
Northern General Hospital	Recruiting
Sheffield, United Kingdom

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Joelle Blumberg, MD

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen ( Joelle Blumberg )
Study ID Numbers:	2-55-52030-726
Study First Received:	July 17, 2006
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00353496 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: Directorate general for the protection of Public health: Medicines; Spain: Spanish Agency of Medicines; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Greece: Ministry of Health and Welfare; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Italy: Ministry of Health; Austria: Federal Ministry for Health Family and Youth

Keywords provided by Ipsen:

Non functioning entero-pancreatic tumours

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Antineoplastic Agents
Pancreatic Neoplasms
Angiopeptin
Endocrine System Diseases
Adenoma, Islet Cell
Cardiovascular Agents
Pharmacologic Actions

Neoplasms
Lanreotide
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Pancreatic Diseases
Adenoma
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009