DRUG
lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Status
Completed
Phase
Phase 3
Enrollment
264
Locations
71
Results
Posted
Publications
3
Study summary
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.
Interventions
DRUG
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
DRUG
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Timeline
First posted
Jul 18, 2006
Study start
Jun 2006
Primary completion
Apr 2013
Study completion
Apr 2013
Results posted
Feb 18, 2015
Registry updated
Mar 5, 2025
Outcomes
Progression-Free Survival (PFS)
Time frame · From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year
Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0
Percentage of Patients Alive & Without Disease Progression
Time frame · Week 48 & 96
Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
Pharmacokinetic Profile of Lanreotide
Time frame · Week 4, 12, 24, 36, 48, 72, 96
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
Change in the Global Health Status Quality of Life Assessment
Time frame · Week 12 to Week 96 (last visit)
Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels
Time frame · Week 12 to Week 96 (last visit)
Percentage of Patients Still Alive Based on Available Overall Survival Data
Time frame · Randomisation to death or last visit, up to 321 weeks
Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.
Eligibility
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
Study locations
Austria · Belgium · Czechia · Denmark · France · Germany · India · Italy · Netherlands · Poland · Slovakia · Spain · Sweden · 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
University of Iowa
Iowa City, Iowa, United States
The John Hopkins Hospital
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
University Hospital
Vienna, Austria
UZ Antwerpen
Antwerp, Belgium
UCL Saint Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
Fakultni nemocnice Na
Bulovce, Prague, Czechia
Fekultni nemocnice Olomouc
Olomouc, Czechia
General faculty
Prague, Czechia
Sygehus Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Hôpital A. Paré
Boulogne-Billancourt, France
Hôpital Beaujon
Clichy, France
CAC Oscar Lambret
Lille, France
Hôpital Edouard Herriot
Lyon, France
CHU la Timone
Marseille, France
Hôpital R. Debré
Reims, France
CHI Frejus St Raphael
Saint-Raphaël, France
Publications
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