Study of Lanreotide Autogel 120mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour (NET729)
This study has been completed.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00842348
First received: February 11, 2009
Last updated: February 29, 2016
Last verified: February 2016
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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 |
| Study Completion Date: | December 2015 |
| 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 (Adult, Senior) |
| 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:
- Was stable at 96 weeks of treatment or
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842348
Locations
| United States, California | |
| Cedars-Sinai Outpatient Cancer Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Maryland | |
| The Johns 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 | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain | |
| Institut Catala Oncologia | |
| 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: | Douglas Fleming | Ipsen |
More Information
| 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: | February 29, 2016 |
| 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Lanreotide Angiopeptin Somatostatin Antineoplastic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016