DRUG
lanreotide (Autogel formulation)
Autogel 120 mg
Status
Completed
Phase
Phase 3
Enrollment
89
Locations
25
Results
Posted
Publications
2
Study summary
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).
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).
Interventions
DRUG
Autogel 120 mg
Timeline
First posted
Feb 12, 2009
Study start
Feb 2009
Primary completion
Dec 2015
Study completion
Dec 2015
Results posted
Feb 17, 2017
Registry updated
Oct 12, 2022
Outcomes
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.
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.
Eligibility
Inclusion Criteria: 1. Had provided written informed consent prior to any study-related procedures. 2. 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. 3. Had a World Health Organisation (WHO) performance score lower than or equal to 2. Exclusion Criteria: 1. 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. 2. Had received any new treatment for the entero-pancreatic NET since the end of participation in the study. 3. Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET. 4. Had been treated with radionuclide at any time prior to study entry. 5. Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg. 6. Were likely to require treatment during the study with drugs that were not permitted by the study protocol. 7. 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. 8. 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. 9. 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. 10. Previous enrolment in this study.
Study locations
Belgium · Czechia · France · Italy · Poland · Slovakia · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
UZ Antwerpen
Antwerp, Belgium
UCL Saint Luc
Brussels, Belgium
Fakultni nemocnice Na Bulovce
Prague, Czechia
General faculty
Prague, Czechia
Hôpital Beaujon
Clichy, France
CAC Oscar Lambret
Lille, France
Hôpital Edouard Herriot
Lyon, France
Hôpital R. Debré
Reims, France
Centro di Refierimiento Oncologica
Aviano, Italy
INSCT
Milan, Italy
University of Naples
Naples, Italy
Azienda San Giovanni Battista
Torino, Italy
Centrum Diagnostyczno-Lecznicze "Gammed"
Warsaw, Poland
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny
Warsaw, Poland
Narodny onkologicky ustav
Bratislava, Slovakia
Hospital Vall d'Hebron
Barcelona, Spain
Institut Catala Oncologia
Barcelona, Spain
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
Publications
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