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Study of Lanreotide Autogel 120 mg 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: December 28, 2016
Last verified: December 2016
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Purpose
The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).
| Condition | Intervention | Phase |
|---|---|---|
| Non Functioning Entero-pancreatic Endocrine Tumour | Drug: lanreotide (Autogel formulation) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Carcinoid Tumor
Pancreatic Neuroendocrine Tumor
U.S. FDA Resources
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Adverse Events [ Time Frame: Throughout the study until the completion/early discontinuation visit. ]
Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.
An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:
- It was not present prior to receiving the first dose of study treatment in Study 729; or,
- It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.
Adverse event data are presented in the AE section.
Secondary Outcome Measures:
- Progression Free Survival (PFS): Kaplan-Meier Estimate [ Time Frame: Throughout the study (every 24 weeks and at completion/withdrawal visit) ]
The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours [RECIST] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.
Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method.
| Enrollment: | 89 |
| Study Start Date: | February 2009 |
| 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)
Patients from the preceding DB study (Study 726) were treated with open label lanreotide Autogel 120 mg by deep subcutaneous injections every 28 days. Patients were included if they had been treated with lanreotide (Autogel formulation) or placebo in DB Study 726 and had stable disease at the end of the 96-week treatment period, or if they had received placebo and had disease progression at any time during Study 726. Safety data were based on the safety population patients who received lanreotide in Study 729). The main efficacy analysis was based on the ITT population (patients randomised in Study 726 regardless of whether they continued into Study 729).
|
Drug: lanreotide (Autogel formulation)
Autogel 120 mg
Other Names:
|
Detailed Description:
While somatostatin analogue treatment is the primary medical therapy for patients with hormone related symptoms and is indicated for the treatment of hormone related symptoms in many international countries, there is no reference standard medical therapy for asymptomatic patients. A 96-week study (Study 2-55-52030-726 (726), NCT00353496) was conducted to investigate the effect of lanreotide Autogel on progression free survival (PFS) in patients with well or moderately differentiated nonfunctioning enteropancreatic NET. While Study 726 was ongoing, the sponsor considered that therapy with lanreotide Autogel should continue to be an option to patients with stable disease at the end of the 96-week treatment period. This extension study was therefore initiated (Study 2-55-52030-729 (729)) which investigated the long term safety of treatment with lanreotide Autogel and enabled investigators to continue to treat their patients who had stable disease, as well as to treat placebo patients who experienced disease progression during the initial 96-week study (Study 726).
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Had provided written informed consent prior to any study-related procedures.
-
Had been enrolled and treated in Study 2-55-52030-726 and either:
- Was stable at 96 weeks of treatment (whatever the treatment received during the 2 years of participation, i.e. no code break at Week 96); or,
- Had received at least one injection in Study 2-55-52030-726 and had disease progression, confirmed by central assessment, during the course of the study and code break showed placebo.
- Had a World Health Organisation (WHO) performance score lower than or equal to 2.
Exclusion Criteria:
- Had been enrolled and treated in the frame of the protocol and had disease progression during the study and the code break showed a treatment with lanreotide Autogel 120 mg.
- Had received any new treatment for the entero-pancreatic NET since the end of participation in the study.
- Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET.
- Had been treated with radionuclide at any time prior to study entry.
- Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg.
- Were likely to require treatment during the study with drugs that were not permitted by the study protocol.
- Were at risk of pregnancy or lactation. Females of childbearing potential had to provide a negative pregnancy test at the start of study and had to be using oral, double barrier or injectable contraception. Non-childbearing potential was defined as postmenopause for at least 1 year, or surgical sterilisation or hysterectomy at least 3 months before the start of the study.
- Had any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- Had abnormal findings at Visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might have jeopardised the patient's safety or decreased the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- Previous enrolment in this study.
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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
Publications:
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00842348 History of Changes |
| Other Study ID Numbers: |
2-55-52030-729 2008-004019-36 ( EudraCT Number ) |
| Study First Received: | February 11, 2009 |
| Results First Received: | December 28, 2016 |
| Last Updated: | December 28, 2016 |
Keywords provided by Ipsen:
|
Lanreotide Somatuline Neuroendocrine tumour NET |
Additional relevant MeSH terms:
|
Endocrine Gland Neoplasms Adenoma, Islet Cell Neoplasms by Site Neoplasms Endocrine System Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Pancreatic Neoplasms Digestive System Neoplasms |
Digestive System Diseases Pancreatic Diseases Lanreotide Angiopeptin Somatostatin Antineoplastic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017