Study of Lanreotide Autogel 120mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour (NET729)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00842348
First received: February 11, 2009
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

The purpose of this extension study is to assess the long term safety of patients with neuroendocrine tumour, who are treated with lanreotide Autogel and who participated in a previous study, 2-55-52030-726.


Condition Intervention Phase
Non Functioning Entero-pancreatic Endocrine Tumour
Drug: lanreotide (Autogel formulation)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Extension Study of Lanreotide Autogel 120mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to death or first occurrence of disease progression [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: September 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lanreotide (Autogel formulation) Drug: lanreotide (Autogel formulation)
Autogel 120mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:-

  • Has provided written informed consent prior to any study-related procedures
  • Has been enrolled and treated in Study 2-55-52030-726 and either:

    1. Was stable at 96 weeks of treatment or
    2. Has received at least one injection in Study 2-55-52030-726 and had a disease progression and was in the placebo arm
  • Has a World Health Organisation (WHO) performance score lower than or equal to 2

Exclusion Criteria:

  • Has been enrolled and treated in the frame of the 2-55-52030-726 protocol and had a disease progression when receiving lanreotide Autogel 120mg
  • Has received any new treatment for the entero-pancreatic neuroendocrine tumour since the end of participation in the 2-55-52030-726 study
  • Is likely to require any additional concomitant treatment to lanreotide Autogel 120mg for the entero-pancreatic neuro-endocrine tumour
  • Has a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120mg
  • Has been treated with radionuclide at any time prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842348

Locations
United States, California
Ceders-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
United States, Maryland
The John Hopkins Hospital
Baltimore, Maryland, United States, 21287-4606
Belgium
UZ Antwerpen
Antwerpen, Belgium
UCL Saint Luc
Bruxelles, Belgium
Czech Republic
Fakultni nemocnice Na Bulovce
Prague, Czech Republic
General faculty
Praha, Czech Republic
France
Hôpital Beaujon
Clichy, France, 92118
CAC Oscar Lambret
Lille, France, 59020
Hôpital Edouard Herriot
Lyon, France, 69437
Hôpital R. Debré
Reims, France, 51092
Italy
Centro di Refierimiento Oncologica
Aviano, Italy
INSCT
Milano, Italy
University of Naples
Naples, Italy
Azienda San Giovanni Battista
Torino, Italy
Poland
Centrum Diagnostyczno-Lecznicze "Gammed"
Warszawa, Poland
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny
Warszawa, Poland
Slovakia
Narodny onkologicky ustav
Bratislava, Slovakia
Spain
Institut Catala Oncologia
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
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
Royal Free Hospital
London, United Kingdom
QMC
Nottingham, United Kingdom
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Joelle Blumberg, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00842348     History of Changes
Other Study ID Numbers: 2-55-52030-729, 2008-004019-36
Study First Received: February 11, 2009
Last Updated: August 21, 2014
Health Authority: France: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Italy: Ministry of Health
Poland: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenoma, Islet Cell
Endocrine Gland Neoplasms
Adenoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Pancreatic Neoplasms
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014