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

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ClinicalTrials.gov Identifier: NCT00353496

Recruitment Status : Completed

First Posted : July 18, 2006

Results First Posted : February 18, 2015

Last Update Posted : October 12, 2022

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Sponsor:

Information provided by (Responsible Party):

Ipsen

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Endocrine Tumors
Interventions	Drug: lanreotide (Autogel formulation) Drug: Placebo
Enrollment	264

Participant Flow

Recruitment Details	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.
Pre-assignment Details


Arm/Group Title	Lanreotide (Autogel Formulation)	Placebo
Arm/Group Description	120mg administered via deep subcuta...	Placebo: Saline solution 0.9% admin...
Arm/Group Description	120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.	Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Period Title: Overall Study
Started	101	103
Completed	85 ^[1]	86
Not Completed	16	17
Reason Not Completed
Adverse Event	1	0
Protocol Violation	2	2
Withdrawal by Subject	3	4
Physician Decision	6	9
Not otherwise specified	4	2
[1] Patients who completed specified assessments or met primary efficacy endpoint criteria for an event.

Baseline Characteristics

Arm/Group Title		Lanreotide (Autogel Formulation)	Placebo	Total
Arm/Group Description		120mg administered via deep subcuta...	Saline solution 0.9% administered v...	Total of all reporting groups
Arm/Group Description		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.	Total of all reporting groups
Overall Number of Baseline Participants		101	103	204
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Analysis based on intent-to-treat (ITT) population comprised of 204 subjects.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	101 participants	103 participants	204 participants
		63 (10)	62 (11)	63 (11)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	101 participants	103 participants	204 participants
	Female	48 47.5%	49 47.6%	97 47.5%
	Male	53 52.5%	54 52.4%	107 52.5%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	101 participants	103 participants	204 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	2 2.0%	5 4.9%	7 3.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 2.0%	2 1.9%	4 2.0%
	White	97 96.0%	96 93.2%	193 94.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Time since diagnosis ^[1] Mean (Standard Deviation) Unit of measure: Months
	Number Analyzed	101 participants	103 participants	204 participants
		32.6 (46.1)	34.4 (41.4)	33.5 (43.7)
		[1] Measure Description: Time relative to baseline visit (Week 1).
Neuroendocrine tumour (NET) origin ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	101 participants	103 participants	204 participants
Pancreas		42	49	91
Midgut		33	40	73
Hindgut		11	3	14
Unknown/Other		15	11	26
		[1] Measure Description: Primary tumour characteristics.
Chromogranin A ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	101 participants	103 participants	204 participants
≤1 × ULN		33	34	67
1-2 × ULN		25	18	43
>2 × ULN		41	48	89
Unknown		2	3	5
		[1] Measure Description: Chromogranin A is an NET marker. ULN: upper limit of normal.

Outcome Measures

1.Primary Outcome


Title	Progression-Free Survival (PFS)
Description	Time from randomization to first documentation of disease progression,...
Description	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

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Lanreotide (Autogel Formulation)	Placebo
Arm/Group Description:	lanreotide (Autogel formulation): 1...	Placebo: Saline solution 0.9% admin...
Arm/Group Description:	lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Overall Number of Participants Analyzed	101	103
Median (95% Confidence Interval) Unit of Measure: Weeks
	NA ^[1] (NA to NA)	72 (48.6 to 96.0)

[1]

Not available as median not reached during the 96 week fixed duration study.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lanreotide (Autogel Formulation), Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	No p-value adjustment for multiple comparisons.
	Method	Log Rank
	Comments	The log rank test was stratified according to progression status at baseline and prior therapy.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95% 0.30 to 0.73
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Percentage of Patients Alive & Without Disease Progression
Description	Percentage of patients still ongoing (or completing at Week 96) withou...
Description	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

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Lanreotide (Autogel Formulation)	Placebo
Arm/Group Description:	lanreotide (Autogel formulation): 1...	Placebo: Saline solution 0.9% admin...
Arm/Group Description:	lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Overall Number of Participants Analyzed	101	103
Measure Type: Number Unit of Measure: Percentage of participants
Week 48	66	49
Week 96	53	25

3.Secondary Outcome


Title	Pharmacokinetic Profile of Lanreotide
Description	Pharmacokinetic Profile of Lanreotide assessed by mean serum concentra...
Description	Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
Time Frame	Week 4, 12, 24, 36, 48, 72, 96

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Lanreotide (Autogel Formulation)
Arm/Group Description:	lanreotide (Autogel formulation): 1...
Arm/Group Description:	lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Overall Number of Participants Analyzed	101
Mean (Standard Deviation) Unit of Measure: ng/mL
At Week 4 predose (n=81)	2.5 (0.46)
At Week 12 predose (n=87)	5.0 (0.42)
At Week 24 predose (n=74)	6.1 (0.44)
At Week 36 predose (n=67)	6.2 (0.39)
At Week 48 predose (n=62)	6.6 (0.45)
At Week 72 predose (n=52)	6.8 (0.44)
At Week 96 predose (n=48)	6.6 (0.39)

4.Secondary Outcome


Title	Change in the Global Health Status Quality of Life Assessment
Description	Transformed scores from European Organisation for Research and Treatme...
Description	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)

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Lanreotide (Autogel Formulation)	Placebo
Arm/Group Description:	lanreotide (Autogel formulation): 1...	Placebo: Saline solution 0.9% admin...
Arm/Group Description:	lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Overall Number of Participants Analyzed	95	98
Least Squares Mean (Standard Error) Unit of Measure: score on a scale
	-5.2 (3.7)	-4.9 (3.7)

5.Secondary Outcome


Title	Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Week 12 to Week 96 (last visit)

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Lanreotide (Autogel Formulation)	Placebo
Arm/Group Description:	lanreotide (Autogel formulation): 1...	Placebo: Saline solution 0.9% admin...
Arm/Group Description:	lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Overall Number of Participants Analyzed	64	64
Measure Type: Number Unit of Measure: percentage of participants
	42.2	4.7

6.Secondary Outcome


Title	Percentage of Patients Still Alive Based on Available Overall Survival Data
Description	Overall survival defined as the time from randomisation to death due t...
Description	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.
Time Frame	Randomisation to death or last visit, up to 321 weeks

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Lanreotide (Autogel Formulation)	Placebo
Arm/Group Description:	lanreotide (Autogel formulation): 1...	Placebo: Saline solution 0.9% admin...
Arm/Group Description:	lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.	Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Overall Number of Participants Analyzed	101	103
Measure Type: Number Unit of Measure: percentage of participants
	84	77

Adverse Events

Time Frame	Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Lanreotide (Autogel Formulation)		Placebo
Arm/Group Description	120mg administered via deep subcuta...		Saline solution 0.9% administered v...
Arm/Group Description	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.
All-Cause Mortality
	Lanreotide (Autogel Formulation)		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Lanreotide (Autogel Formulation)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/101 (24.75%)		32/103 (31.07%)
Blood and lymphatic system disorders
Anaemia ^† 1	3/101 (2.97%)	3	0/103 (0.00%)	0
Cardiac disorders
Aortic valve stenosis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Cardiac failure ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Coronary artery disease ^† 1	0/101 (0.00%)	0	2/103 (1.94%)	2
Myocardial infarction ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Pericarditis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Ear and labyrinth disorders
Vertigo ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Endocrine disorders
Hyperthyroidism ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Toxic nodular goitre ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	1/101 (0.99%)	1	1/103 (0.97%)	1
Abdominal pain lower ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Abdominal pain upper ^† 1	2/101 (1.98%)	2	0/103 (0.00%)	0
Ascites ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Constipation ^† 1	1/101 (0.99%)	1	1/103 (0.97%)	1
Diarrhoea ^† 1	0/101 (0.00%)	0	2/103 (1.94%)	3
Diverticulum ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	2
Gastrointestinal haemorrhage ^† 1	1/101 (0.99%)	2	2/103 (1.94%)	2
Haematemesis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Ileus ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Inguinal hernia ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Intestinal obstruction ^† 1	2/101 (1.98%)	2	1/103 (0.97%)	1
Large intestine perforation ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Nausea ^† 1	1/101 (0.99%)	1	2/103 (1.94%)	3
Peptic ulcer ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Vomiting ^† 1	4/101 (3.96%)	4	2/103 (1.94%)	3
General disorders
Chills ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Pyrexia ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Hepatobiliary disorders
Bile duct stenosis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Biliary fistula ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Cholelithiasis ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Cholestasis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Hepatic failure ^† 1	2/101 (1.98%)	2	0/103 (0.00%)	0
Hepatic necrosis ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Hyperbilirubinaemia ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Jaundice ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Jaundice cholestatic ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	2
Immune system disorders
Anaphylactic reaction ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Infections and infestations
Gastroenteritis ^† 1	0/101 (0.00%)	0	2/103 (1.94%)	2
Infected dermal cyst ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Liver abscess ^† 1	2/101 (1.98%)	2	0/103 (0.00%)	0
Orchitis ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Pneumonia ^† 1	2/101 (1.98%)	2	0/103 (0.00%)	0
Pulmonary tuberculosis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Sepsis ^† 1	2/101 (1.98%)	2	0/103 (0.00%)	0
Urinary tract infection ^† 1	3/101 (2.97%)	3	1/103 (0.97%)	4
Urosepsis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Injury, poisoning and procedural complications
Anastomotic ulcer ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Humerus fracture ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Radius fracture ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Metabolism and nutrition disorders
Dehydration ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Diabetes mellitus ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Electrolyte imbalance ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Hypercalcaemia ^† 1	1/101 (0.99%)	2	0/103 (0.00%)	0
Hyperglycaemia ^† 1	2/101 (1.98%)	2	0/103 (0.00%)	0
Hypoglycaemia ^† 1	0/101 (0.00%)	0	2/103 (1.94%)	2
Hypokalaemia ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	2
Musculoskeletal and connective tissue disorders
Back pain ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Pain in extremity ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Spinal osteoarthritis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Bronchial carcinoma ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Endometrial adenocarcinoma ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Metastases to liver ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Oesophageal carcinoma ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Nervous system disorders
Dizziness ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Spinal cord compression ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Psychiatric disorders
Confusional state ^† 1	0/101 (0.00%)	0	3/103 (2.91%)	3
Renal and urinary disorders
Renal failure ^† 1	1/101 (0.99%)	2	0/103 (0.00%)	0
Renal failure acute ^† 1	1/101 (0.99%)	1	1/103 (0.97%)	1
Reproductive system and breast disorders
Cervical dysplasia ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Respiratory, thoracic and mediastinal disorders
Hypoxia ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
Pleural effusion ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Pulmonary embolism ^† 1	1/101 (0.99%)	1	1/103 (0.97%)	1
Vascular disorders
Circulatory collapse ^† 1	1/101 (0.99%)	1	1/103 (0.97%)	1
Hypertensive crisis ^† 1	1/101 (0.99%)	1	0/103 (0.00%)	0
Vena cava thrombosis ^† 1	0/101 (0.00%)	0	1/103 (0.97%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 16.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lanreotide (Autogel Formulation)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	88/101 (87.13%)		92/103 (89.32%)
Gastrointestinal disorders
Abdominal discomfort ^† 1	5/101 (4.95%)	8	3/103 (2.91%)	4
Abdominal pain ^† 1	23/101 (22.77%)	32	18/103 (17.48%)	34
Abdominal pain upper ^† 1	7/101 (6.93%)	7	9/103 (8.74%)	15
Constipation ^† 1	11/101 (10.89%)	13	14/103 (13.59%)	16
Diarrhoea ^† 1	35/101 (34.65%)	57	37/103 (35.92%)	75
Flatulence ^† 1	12/101 (11.88%)	13	9/103 (8.74%)	12
Nausea ^† 1	15/101 (14.85%)	28	13/103 (12.62%)	22
Vomiting ^† 1	17/101 (16.83%)	21	10/103 (9.71%)	28
General disorders
Asthenia ^† 1	8/101 (7.92%)	8	6/103 (5.83%)	6
Fatigue ^† 1	11/101 (10.89%)	15	16/103 (15.53%)	18
Injection site pain ^† 1	8/101 (7.92%)	30	4/103 (3.88%)	10
Oedema peripheral ^† 1	5/101 (4.95%)	5	7/103 (6.80%)	12
Pyrexia ^† 1	4/101 (3.96%)	6	6/103 (5.83%)	7
Hepatobiliary disorders
Cholelithiasis ^† 1	15/101 (14.85%)	16	7/103 (6.80%)	7
Infections and infestations
Nasopharyngitis ^† 1	9/101 (8.91%)	10	17/103 (16.50%)	23
Upper respiratory tract infection ^† 1	3/101 (2.97%)	5	6/103 (5.83%)	6
Urinary tract infection ^† 1	8/101 (7.92%)	13	11/103 (10.68%)	13
Investigations
Pancreatic enzymes decreased ^† 1	6/101 (5.94%)	7	0/103 (0.00%)	0
Weight decreased ^† 1	9/101 (8.91%)	9	9/103 (8.74%)	10
Metabolism and nutrition disorders
Decreased appetite ^† 1	10/101 (9.90%)	11	9/103 (8.74%)	11
Dehydration ^† 1	5/101 (4.95%)	7	1/103 (0.97%)	1
Diabetes mellitus ^† 1	9/101 (8.91%)	9	4/103 (3.88%)	5
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	10/101 (9.90%)	15	10/103 (9.71%)	11
Back pain ^† 1	11/101 (10.89%)	12	11/103 (10.68%)	11
Muscle spasms ^† 1	5/101 (4.95%)	5	4/103 (3.88%)	4
Musculoskeletal pain ^† 1	7/101 (6.93%)	8	3/103 (2.91%)	6
Nervous system disorders
Dizziness ^† 1	9/101 (8.91%)	12	1/103 (0.97%)	1
Headache ^† 1	16/101 (15.84%)	19	11/103 (10.68%)	19
Lethargy ^† 1	5/101 (4.95%)	13	4/103 (3.88%)	4
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	5/101 (4.95%)	5	3/103 (2.91%)	8
Dyspnoea ^† 1	6/101 (5.94%)	7	1/103 (0.97%)	2
Oropharyngeal pain ^† 1	5/101 (4.95%)	5	3/103 (2.91%)	4
Skin and subcutaneous tissue disorders
Alopecia ^† 1	5/101 (4.95%)	5	4/103 (3.88%)	4
Pruritus ^† 1	5/101 (4.95%)	5	5/103 (4.85%)	17
Rash ^† 1	7/101 (6.93%)	8	3/103 (2.91%)	3
Vascular disorders
Flushing ^† 1	4/101 (3.96%)	4	6/103 (5.83%)	6
Hypertension ^† 1	13/101 (12.87%)	16	5/103 (4.85%)	5
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 16.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Medical Director Endocrinology
Organization:	Ipsen
Phone:	clinical.trials@ipsen.com
EMail:	clinical.trials@ipsen.com

Publications of Results:

Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Caplin ME, Pavel M, Phan AT, Cwikla JB, Sedlackova E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.

Lybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel((R)): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep.

Layout table for additonal information

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT00353496
Other Study ID Numbers:	2-55-52030-726 2005-004904-35 ( EudraCT Number )
First Submitted:	July 17, 2006
First Posted:	July 18, 2006
Results First Submitted:	January 15, 2015
Results First Posted:	February 18, 2015
Last Update Posted:	October 12, 2022

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