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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
264
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Progression-Free Survival (PFS)
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
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
Percentage of Patients Alive & Without Disease Progression
Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
Time frame: Week 48 & 96
Pharmacokinetic Profile of Lanreotide
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
Time frame: Week 4, 12, 24, 36, 48, 72, 96
Change in the Global Health Status Quality of Life Assessment
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.
Time frame: Week 12 to Week 96 (last visit)
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
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.
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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
...and 61 more locations
Time frame: Randomisation to death or last visit, up to 321 weeks