Trial Outcomes & Findings for Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours (NCT NCT00353496)

Last Updated: 2025-03-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

264 participants

Primary outcome timeframe

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

Results posted on

2025-03-05

Participant Flow

264 subjects were screened at 48 investigational sites in 14 countries (Austria, Belgium, Czech Republic, Denmark, France, Germany, India, Italy, Poland, Slovakia, Spain, Sweden, United Kingdom and the United States of America). 204 subjects were randomised to receive study treatment in the Intent to treat (ITT) population.

Participant milestones

Participant milestones
Measure	Lanreotide (Autogel Formulation) 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.	Placebo Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Overall Study STARTED	101	103
Overall Study COMPLETED	85	86
Overall Study NOT COMPLETED	16	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Lanreotide (Autogel Formulation) 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.	Placebo Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Overall Study Adverse Event	1	0
Overall Study Protocol Violation	2	2
Overall Study Withdrawal by Subject	3	4
Overall Study Physician Decision	6	9
Overall Study Not otherwise specified	4	2

Baseline Characteristics

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lanreotide (Autogel Formulation) n=101 Participants 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.	Placebo n=103 Participants Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.	Total n=204 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 10 • n=99 Participants	62 years STANDARD_DEVIATION 11 • n=107 Participants	63 years STANDARD_DEVIATION 11 • n=206 Participants
Sex: Female, Male Female	48 Participants n=99 Participants	49 Participants n=107 Participants	97 Participants n=206 Participants
Sex: Female, Male Male	53 Participants n=99 Participants	54 Participants n=107 Participants	107 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	97 Participants n=99 Participants	96 Participants n=107 Participants	193 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Time since diagnosis	32.6 months STANDARD_DEVIATION 46.1 • n=99 Participants	34.4 months STANDARD_DEVIATION 41.4 • n=107 Participants	33.5 months STANDARD_DEVIATION 43.7 • n=206 Participants
Neuroendocrine tumour (NET) origin Pancreas	42 participants n=99 Participants	49 participants n=107 Participants	91 participants n=206 Participants
Neuroendocrine tumour (NET) origin Midgut	33 participants n=99 Participants	40 participants n=107 Participants	73 participants n=206 Participants
Neuroendocrine tumour (NET) origin Hindgut	11 participants n=99 Participants	3 participants n=107 Participants	14 participants n=206 Participants
Neuroendocrine tumour (NET) origin Unknown/Other	15 participants n=99 Participants	11 participants n=107 Participants	26 participants n=206 Participants
Chromogranin A ≤1 × ULN	33 participants n=99 Participants	34 participants n=107 Participants	67 participants n=206 Participants
Chromogranin A 1-2 × ULN	25 participants n=99 Participants	18 participants n=107 Participants	43 participants n=206 Participants
Chromogranin A >2 × ULN	41 participants n=99 Participants	48 participants n=107 Participants	89 participants n=206 Participants
Chromogranin A Unknown	2 participants n=99 Participants	3 participants n=107 Participants	5 participants n=206 Participants

PRIMARY outcome

Timeframe: 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

Population: Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.

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

Outcome measures

Outcome measures
Measure	Lanreotide (Autogel Formulation) n=101 Participants lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo n=103 Participants Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Progression-Free Survival (PFS)	NA Weeks Not available as median not reached during the 96 week fixed duration study.	72 Weeks Interval 48.6 to 96.0

SECONDARY outcome

Timeframe: Week 48 & 96

Population: Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.

Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.

Outcome measures

Outcome measures
Measure	Lanreotide (Autogel Formulation) n=101 Participants lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo n=103 Participants Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Percentage of Patients Alive & Without Disease Progression Week 48	66 Percentage of participants	49 Percentage of participants
Percentage of Patients Alive & Without Disease Progression Week 96	53 Percentage of participants	25 Percentage of participants

SECONDARY outcome

Timeframe: Week 4, 12, 24, 36, 48, 72, 96

Population: Analysis based on the intent-to-treat (ITT) population which comprised 101 randomised subjects who received lanreotide

Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints

Outcome measures

Outcome measures
Measure	Lanreotide (Autogel Formulation) n=101 Participants lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Pharmacokinetic Profile of Lanreotide At Week 48 predose (n=62)	6.6 ng/mL Standard Deviation 0.45	—
Pharmacokinetic Profile of Lanreotide At Week 72 predose (n=52)	6.8 ng/mL Standard Deviation 0.44	—
Pharmacokinetic Profile of Lanreotide At Week 96 predose (n=48)	6.6 ng/mL Standard Deviation 0.39	—
Pharmacokinetic Profile of Lanreotide At Week 4 predose (n=81)	2.5 ng/mL Standard Deviation 0.46	—
Pharmacokinetic Profile of Lanreotide At Week 12 predose (n=87)	5.0 ng/mL Standard Deviation 0.42	—
Pharmacokinetic Profile of Lanreotide At Week 24 predose (n=74)	6.1 ng/mL Standard Deviation 0.44	—
Pharmacokinetic Profile of Lanreotide At Week 36 predose (n=67)	6.2 ng/mL Standard Deviation 0.39	—

SECONDARY outcome

Timeframe: Week 12 to Week 96 (last visit)

Population: Analysis based on the intent-to-treat (ITT) population which comprised 193 randomised subjects with valid 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.

Outcome measures

Outcome measures
Measure	Lanreotide (Autogel Formulation) n=95 Participants lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo n=98 Participants Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Change in the Global Health Status Quality of Life Assessment	-5.2 score on a scale Standard Error 3.7	-4.9 score on a scale Standard Error 3.7

SECONDARY outcome

Timeframe: Week 12 to Week 96 (last visit)

Population: Analysis based on the subgroup of subjects with an elevated plasma CgA values. Subjects with a gastrinoma were excluded from the analysis.

Outcome measures

Outcome measures
Measure	Lanreotide (Autogel Formulation) n=64 Participants lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo n=64 Participants Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels	42.2 percentage of participants	4.7 percentage of participants

SECONDARY outcome

Timeframe: Randomisation to death or last visit, up to 321 weeks

Population: Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.

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.

Outcome measures

Outcome measures
Measure	Lanreotide (Autogel Formulation) n=101 Participants lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo n=103 Participants Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Percentage of Patients Still Alive Based on Available Overall Survival Data	84 percentage of participants	77 percentage of participants

Adverse Events

Lanreotide (Autogel Formulation)

Serious events: 25 serious events

Other events: 88 other events

Deaths: 0 deaths

Placebo

Serious events: 32 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Director Endocrinology

Ipsen

Phone: [email protected]

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lanreotide (Autogel Formulation) n=101 participants at risk 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.	Placebo n=103 participants at risk Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Gastrointestinal disorders Abdominal discomfort	5.0% 5/101 • Number of events 8 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	2.9% 3/103 • Number of events 4 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Gastrointestinal disorders Abdominal pain	22.8% 23/101 • Number of events 32 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	17.5% 18/103 • Number of events 34 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Gastrointestinal disorders Abdominal pain upper	6.9% 7/101 • Number of events 7 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	8.7% 9/103 • Number of events 15 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Skin and subcutaneous tissue disorders Alopecia	5.0% 5/101 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	3.9% 4/103 • Number of events 4 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Musculoskeletal and connective tissue disorders Arthralgia	9.9% 10/101 • Number of events 15 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	9.7% 10/103 • Number of events 11 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
General disorders Asthenia	7.9% 8/101 • Number of events 8 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	5.8% 6/103 • Number of events 6 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Musculoskeletal and connective tissue disorders Back pain	10.9% 11/101 • Number of events 12 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	10.7% 11/103 • Number of events 11 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Hepatobiliary disorders Cholelithiasis	14.9% 15/101 • Number of events 16 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	6.8% 7/103 • Number of events 7 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Gastrointestinal disorders Constipation	10.9% 11/101 • Number of events 13 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	13.6% 14/103 • Number of events 16 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 5/101 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	2.9% 3/103 • Number of events 8 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Metabolism and nutrition disorders Decreased appetite	9.9% 10/101 • Number of events 11 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	8.7% 9/103 • Number of events 11 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Metabolism and nutrition disorders Dehydration	5.0% 5/101 • Number of events 7 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	0.97% 1/103 • Number of events 1 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Metabolism and nutrition disorders Diabetes mellitus	8.9% 9/101 • Number of events 9 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	3.9% 4/103 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Gastrointestinal disorders Diarrhoea	34.7% 35/101 • Number of events 57 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	35.9% 37/103 • Number of events 75 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Nervous system disorders Dizziness	8.9% 9/101 • Number of events 12 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	0.97% 1/103 • Number of events 1 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 6/101 • Number of events 7 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	0.97% 1/103 • Number of events 2 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
General disorders Fatigue	10.9% 11/101 • Number of events 15 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	15.5% 16/103 • Number of events 18 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Gastrointestinal disorders Flatulence	11.9% 12/101 • Number of events 13 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	8.7% 9/103 • Number of events 12 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Vascular disorders Flushing	4.0% 4/101 • Number of events 4 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	5.8% 6/103 • Number of events 6 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Nervous system disorders Headache	15.8% 16/101 • Number of events 19 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	10.7% 11/103 • Number of events 19 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Vascular disorders Hypertension	12.9% 13/101 • Number of events 16 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	4.9% 5/103 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
General disorders Injection site pain	7.9% 8/101 • Number of events 30 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	3.9% 4/103 • Number of events 10 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Nervous system disorders Lethargy	5.0% 5/101 • Number of events 13 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	3.9% 4/103 • Number of events 4 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Musculoskeletal and connective tissue disorders Muscle spasms	5.0% 5/101 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	3.9% 4/103 • Number of events 4 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.9% 7/101 • Number of events 8 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	2.9% 3/103 • Number of events 6 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Infections and infestations Nasopharyngitis	8.9% 9/101 • Number of events 10 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	16.5% 17/103 • Number of events 23 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Gastrointestinal disorders Nausea	14.9% 15/101 • Number of events 28 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	12.6% 13/103 • Number of events 22 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
General disorders Oedema peripheral	5.0% 5/101 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	6.8% 7/103 • Number of events 12 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 5/101 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	2.9% 3/103 • Number of events 4 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Investigations Pancreatic enzymes decreased	5.9% 6/101 • Number of events 7 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	0.00% 0/103 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Skin and subcutaneous tissue disorders Pruritus	5.0% 5/101 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	4.9% 5/103 • Number of events 17 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
General disorders Pyrexia	4.0% 4/101 • Number of events 6 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	5.8% 6/103 • Number of events 7 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Skin and subcutaneous tissue disorders Rash	6.9% 7/101 • Number of events 8 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	2.9% 3/103 • Number of events 3 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Infections and infestations Upper respiratory tract infection	3.0% 3/101 • Number of events 5 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	5.8% 6/103 • Number of events 6 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Infections and infestations Urinary tract infection	7.9% 8/101 • Number of events 13 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	10.7% 11/103 • Number of events 13 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Gastrointestinal disorders Vomiting	16.8% 17/101 • Number of events 21 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	9.7% 10/103 • Number of events 28 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Investigations Weight decreased	8.9% 9/101 • Number of events 9 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.	8.7% 9/103 • Number of events 10 • Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.