CLARINET: Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT00353496
Collaborator
(none)
264
71
2
82
3.7
0
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
Study Start Date
:
Jun 1, 2006
Actual Primary Completion Date
:
Apr 1, 2013
Actual Study Completion Date
:
Apr 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: lanreotide (Autogel formulation)
|
Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) [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
Secondary Outcome Measures
- Percentage of Patients Alive & Without Disease Progression [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 [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 [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 [Week 12 to Week 96 (last visit)]
- Percentage of Patients Still Alive Based on Available Overall Survival Data [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 Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Outpatient Cancer Center | Los Angeles | California | United States | 90048 |
| 2 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 3 | The John Hopkins Hospital | Baltimore | Maryland | United States | 21287-4606 |
| 4 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 5 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 6 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 7 | MD Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
| 8 | University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | United States | 53792-5666 |
| 9 | University Hospital | Vienna | Austria | ||
| 10 | UZ Antwerpen | Antwerpen | Belgium | ||
| 11 | UCL Saint Luc | Bruxelles | Belgium | ||
| 12 | UZ Gent | Gent | Belgium | ||
| 13 | Fakultni nemocnice Na | Bulovce | Prague | Czech Republic | |
| 14 | Fekultni nemocnice Olomouc | Olomouc | Czech Republic | ||
| 15 | General faculty | Praha | Czech Republic | ||
| 16 | Sygehus Hospital | Aarhus | Denmark | ||
| 17 | Rigshospitalet | Copenhagen | Denmark | ||
| 18 | Hôpital A. Paré | Boulogne Billancourt | France | 92100 | |
| 19 | Hôpital Beaujon | Clichy | France | 92118 | |
| 20 | CAC Oscar Lambret | Lille | France | 59020 | |
| 21 | Hôpital Edouard Herriot | Lyon | France | 69437 | |
| 22 | CHU la Timone | Marseille | France | 13385 | |
| 23 | Hôpital R. Debré | Reims | France | 51092 | |
| 24 | CHI Frejus St Raphael | St Raphael | France | 83300 | |
| 25 | Hôpital Rangueil | Toulouse | France | 31059 | |
| 26 | Unité de gastro enterologie IGR | Villejuif | France | 94805 | |
| 27 | Charite Hospital | Berlin | Germany | ||
| 28 | University Hospital | Erlangen | Germany | ||
| 29 | University Hospital | Lubeck | Germany | ||
| 30 | Gutenberg University Hospital | Mainz | Germany | ||
| 31 | University Hospital | Munchen | Germany | ||
| 32 | Lukas Hospital | Neuss | Germany | ||
| 33 | Global Hospital | Hyderabad | India | ||
| 34 | Tata Memorial Hospital | Mumbai | India | ||
| 35 | Centro di Refierimiento Oncologica | Aviano | Italy | ||
| 36 | Azienda Malpighi | Bologna | Italy | ||
| 37 | INSCT | Milano | Italy | ||
| 38 | University of Naples | Naples | Italy | ||
| 39 | Hospital S. Chiara | Pisa | Italy | ||
| 40 | Azienda San Giovanni Battista | Torino | Italy | ||
| 41 | UMC Gronigen | Gronigen | Netherlands | ||
| 42 | Erasmu MC | Rotterdam | Netherlands | ||
| 43 | UMC Utrecht | Utrecht | Netherlands | ||
| 44 | Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul. | Gliwice | Poland | ||
| 45 | Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu | Poznan | Poland | ||
| 46 | Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a | Warszawa | Poland | ||
| 47 | Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego | Warszawa | Poland | ||
| 48 | Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie | Warszawa | Poland | ||
| 49 | Silesian Medical University | Zabrze | Poland | ||
| 50 | Narodny onkologicky ustav, Bratislava | Slovakia | Slovakia | ||
| 51 | Vychodoslovensky onkologicky ustav, Rastislavova | Slovakia | Slovakia | ||
| 52 | Hospital Vall d'Hebron | Barcelona | Spain | ||
| 53 | Institut Catala Oncologia | Barcelona | Spain | ||
| 54 | Hospital G. Maranon | Madrid | Spain | ||
| 55 | Hospital La Paz | Madrid | Spain | ||
| 56 | Hospital Nuestra Senora de la Candelaria | Tenerife | Spain | ||
| 57 | Sahlgrenska Hospital | Goteborg | Sweden | ||
| 58 | Karolinska University Hospital | Stockholm | Sweden | ||
| 59 | University Hospital | Uppsala | Sweden | ||
| 60 | Basingstoke and North Hampshire Hospital | Basingstoke | United Kingdom | ||
| 61 | Royal Victoria Hospital | Belfast | United Kingdom | ||
| 62 | University Hospital Wales | Cardiff | United Kingdom | ||
| 63 | Western General Hospital | Edinburgh | United Kingdom | ||
| 64 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | ||
| 65 | St James Hospital | Leeds | United Kingdom | ||
| 66 | Leicester Royal Infirmary | Leicester | United Kingdom | ||
| 67 | Royal Free Hospital | London | United Kingdom | ||
| 68 | St Bartholomew's Hospital | London | United Kingdom | ||
| 69 | QMC | Nottingham | United Kingdom | ||
| 70 | Churchill Hospital | Oxford | United Kingdom | ||
| 71 | Royal Hallamshire Hospital | Sheffield | United Kingdom |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Medical Director, Endocrinology, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT00353496
Other Study ID Numbers:
- 2-55-52030-726
- 2005-004904-35
First Posted:
Jul 18, 2006
Last Update Posted:
Mar 6, 2015
Last Verified:
Feb 1, 2015
Keywords provided by Ipsen
Additional relevant MeSH terms:
Study Results
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 Detail |
| Arm/Group Title | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| 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 | 86 |
| NOT COMPLETED | 16 | 17 |
Baseline Characteristics
| Arm/Group Title | Lanreotide (Autogel Formulation) | Placebo | Total |
|---|---|---|---|
| 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 Participants | 101 | 103 | 204 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63
(10)
|
62
(11)
|
63
(11)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
48
47.5%
|
49
47.6%
|
97
47.5%
|
| Male |
53
52.5%
|
54
52.4%
|
107
52.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
2%
|
5
4.9%
|
7
3.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
2%
|
2
1.9%
|
4
2%
|
| White |
97
96%
|
96
93.2%
|
193
94.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Time since diagnosis (months) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [months] |
32.6
(46.1)
|
34.4
(41.4)
|
33.5
(43.7)
|
| Neuroendocrine tumour (NET) origin (participants) [Number] | |||
| Pancreas |
42
41.6%
|
49
47.6%
|
91
44.6%
|
| Midgut |
33
32.7%
|
40
38.8%
|
73
35.8%
|
| Hindgut |
11
10.9%
|
3
2.9%
|
14
6.9%
|
| Unknown/Other |
15
14.9%
|
11
10.7%
|
26
12.7%
|
| Chromogranin A (participants) [Number] | |||
| ≤1 × ULN |
33
32.7%
|
34
33%
|
67
32.8%
|
| 1-2 × ULN |
25
24.8%
|
18
17.5%
|
43
21.1%
|
| >2 × ULN |
41
40.6%
|
48
46.6%
|
89
43.6%
|
| Unknown |
2
2%
|
3
2.9%
|
5
2.5%
|
Outcome Measures
| Title | Progression-Free Survival (PFS) |
|---|---|
| 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): 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. |
| Measure Participants | 101 | 103 |
| Median (95% Confidence Interval) [Weeks] |
NA
|
72
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lanreotide (Autogel Formulation), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Patients Alive & Without Disease Progression |
|---|---|
| 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): 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. |
| Measure Participants | 101 | 103 |
| Week 48 |
66
65.3%
|
49
47.6%
|
| Week 96 |
53
52.5%
|
25
24.3%
|
| Title | Pharmacokinetic Profile of Lanreotide |
|---|---|
| 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): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. |
| Measure Participants | 101 |
| 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)
|
| Title | Change in the Global Health Status Quality of Life Assessment |
|---|---|
| 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): 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. |
| Measure Participants | 95 | 98 |
| Least Squares Mean (Standard Error) [score on a scale] |
-5.2
(3.7)
|
-4.9
(3.7)
|
| Title | Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels |
|---|---|
| Description | |
| 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): 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. |
| Measure Participants | 64 | 64 |
| Number [percentage of participants] |
42.2
41.8%
|
4.7
4.6%
|
| Title | Percentage of Patients Still Alive Based on Available Overall Survival Data |
|---|---|
| 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): 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. |
| Measure Participants | 101 | 103 |
| Number [percentage of participants] |
84
83.2%
|
77
74.8%
|
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 | ||||
| Arm/Group Title | Lanreotide (Autogel Formulation) | Placebo | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Lanreotide (Autogel Formulation) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/101 (24.8%) | 32/103 (31.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 3/101 (3%) | 3 | 0/103 (0%) | 0 |
| Cardiac disorders | ||||
| Aortic valve stenosis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Cardiac failure | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Coronary artery disease | 0/101 (0%) | 0 | 2/103 (1.9%) | 2 |
| Myocardial infarction | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Pericarditis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Ear and labyrinth disorders | ||||
| Vertigo | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Endocrine disorders | ||||
| Hyperthyroidism | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Toxic nodular goitre | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/101 (1%) | 1 | 1/103 (1%) | 1 |
| Abdominal pain lower | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Abdominal pain upper | 2/101 (2%) | 2 | 0/103 (0%) | 0 |
| Ascites | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Constipation | 1/101 (1%) | 1 | 1/103 (1%) | 1 |
| Diarrhoea | 0/101 (0%) | 0 | 2/103 (1.9%) | 3 |
| Diverticulum | 0/101 (0%) | 0 | 1/103 (1%) | 2 |
| Gastrointestinal haemorrhage | 1/101 (1%) | 2 | 2/103 (1.9%) | 2 |
| Haematemesis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Ileus | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Inguinal hernia | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Intestinal obstruction | 2/101 (2%) | 2 | 1/103 (1%) | 1 |
| Large intestine perforation | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Nausea | 1/101 (1%) | 1 | 2/103 (1.9%) | 3 |
| Peptic ulcer | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Vomiting | 4/101 (4%) | 4 | 2/103 (1.9%) | 3 |
| General disorders | ||||
| Chills | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Pyrexia | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Hepatobiliary disorders | ||||
| Bile duct stenosis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Biliary fistula | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Cholelithiasis | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Cholestasis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Hepatic failure | 2/101 (2%) | 2 | 0/103 (0%) | 0 |
| Hepatic necrosis | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Hyperbilirubinaemia | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Jaundice | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Jaundice cholestatic | 0/101 (0%) | 0 | 1/103 (1%) | 2 |
| Immune system disorders | ||||
| Anaphylactic reaction | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Infections and infestations | ||||
| Gastroenteritis | 0/101 (0%) | 0 | 2/103 (1.9%) | 2 |
| Infected dermal cyst | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Liver abscess | 2/101 (2%) | 2 | 0/103 (0%) | 0 |
| Orchitis | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Pneumonia | 2/101 (2%) | 2 | 0/103 (0%) | 0 |
| Pulmonary tuberculosis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Sepsis | 2/101 (2%) | 2 | 0/103 (0%) | 0 |
| Urinary tract infection | 3/101 (3%) | 3 | 1/103 (1%) | 4 |
| Urosepsis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Anastomotic ulcer | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Humerus fracture | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Radius fracture | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Diabetes mellitus | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Electrolyte imbalance | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Hypercalcaemia | 1/101 (1%) | 2 | 0/103 (0%) | 0 |
| Hyperglycaemia | 2/101 (2%) | 2 | 0/103 (0%) | 0 |
| Hypoglycaemia | 0/101 (0%) | 0 | 2/103 (1.9%) | 2 |
| Hypokalaemia | 0/101 (0%) | 0 | 1/103 (1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Pain in extremity | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Spinal osteoarthritis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Bladder cancer | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Bronchial carcinoma | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Endometrial adenocarcinoma | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Metastases to liver | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Oesophageal carcinoma | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Nervous system disorders | ||||
| Dizziness | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Spinal cord compression | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Psychiatric disorders | ||||
| Confusional state | 0/101 (0%) | 0 | 3/103 (2.9%) | 3 |
| Renal and urinary disorders | ||||
| Renal failure | 1/101 (1%) | 2 | 0/103 (0%) | 0 |
| Renal failure acute | 1/101 (1%) | 1 | 1/103 (1%) | 1 |
| Reproductive system and breast disorders | ||||
| Cervical dysplasia | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Hypoxia | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
| Pleural effusion | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Pulmonary embolism | 1/101 (1%) | 1 | 1/103 (1%) | 1 |
| Vascular disorders | ||||
| Circulatory collapse | 1/101 (1%) | 1 | 1/103 (1%) | 1 |
| Hypertensive crisis | 1/101 (1%) | 1 | 0/103 (0%) | 0 |
| Vena cava thrombosis | 0/101 (0%) | 0 | 1/103 (1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Lanreotide (Autogel Formulation) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 88/101 (87.1%) | 92/103 (89.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 5/101 (5%) | 8 | 3/103 (2.9%) | 4 |
| Abdominal pain | 23/101 (22.8%) | 32 | 18/103 (17.5%) | 34 |
| Abdominal pain upper | 7/101 (6.9%) | 7 | 9/103 (8.7%) | 15 |
| Constipation | 11/101 (10.9%) | 13 | 14/103 (13.6%) | 16 |
| Diarrhoea | 35/101 (34.7%) | 57 | 37/103 (35.9%) | 75 |
| Flatulence | 12/101 (11.9%) | 13 | 9/103 (8.7%) | 12 |
| Nausea | 15/101 (14.9%) | 28 | 13/103 (12.6%) | 22 |
| Vomiting | 17/101 (16.8%) | 21 | 10/103 (9.7%) | 28 |
| General disorders | ||||
| Asthenia | 8/101 (7.9%) | 8 | 6/103 (5.8%) | 6 |
| Fatigue | 11/101 (10.9%) | 15 | 16/103 (15.5%) | 18 |
| Injection site pain | 8/101 (7.9%) | 30 | 4/103 (3.9%) | 10 |
| Oedema peripheral | 5/101 (5%) | 5 | 7/103 (6.8%) | 12 |
| Pyrexia | 4/101 (4%) | 6 | 6/103 (5.8%) | 7 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 15/101 (14.9%) | 16 | 7/103 (6.8%) | 7 |
| Infections and infestations | ||||
| Nasopharyngitis | 9/101 (8.9%) | 10 | 17/103 (16.5%) | 23 |
| Upper respiratory tract infection | 3/101 (3%) | 5 | 6/103 (5.8%) | 6 |
| Urinary tract infection | 8/101 (7.9%) | 13 | 11/103 (10.7%) | 13 |
| Investigations | ||||
| Pancreatic enzymes decreased | 6/101 (5.9%) | 7 | 0/103 (0%) | 0 |
| Weight decreased | 9/101 (8.9%) | 9 | 9/103 (8.7%) | 10 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 10/101 (9.9%) | 11 | 9/103 (8.7%) | 11 |
| Dehydration | 5/101 (5%) | 7 | 1/103 (1%) | 1 |
| Diabetes mellitus | 9/101 (8.9%) | 9 | 4/103 (3.9%) | 5 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 10/101 (9.9%) | 15 | 10/103 (9.7%) | 11 |
| Back pain | 11/101 (10.9%) | 12 | 11/103 (10.7%) | 11 |
| Muscle spasms | 5/101 (5%) | 5 | 4/103 (3.9%) | 4 |
| Musculoskeletal pain | 7/101 (6.9%) | 8 | 3/103 (2.9%) | 6 |
| Nervous system disorders | ||||
| Dizziness | 9/101 (8.9%) | 12 | 1/103 (1%) | 1 |
| Headache | 16/101 (15.8%) | 19 | 11/103 (10.7%) | 19 |
| Lethargy | 5/101 (5%) | 13 | 4/103 (3.9%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 5/101 (5%) | 5 | 3/103 (2.9%) | 8 |
| Dyspnoea | 6/101 (5.9%) | 7 | 1/103 (1%) | 2 |
| Oropharyngeal pain | 5/101 (5%) | 5 | 3/103 (2.9%) | 4 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 5/101 (5%) | 5 | 4/103 (3.9%) | 4 |
| Pruritus | 5/101 (5%) | 5 | 5/103 (4.9%) | 17 |
| Rash | 7/101 (6.9%) | 8 | 3/103 (2.9%) | 3 |
| Vascular disorders | ||||
| Flushing | 4/101 (4%) | 4 | 6/103 (5.8%) | 6 |
| Hypertension | 13/101 (12.9%) | 16 | 5/103 (4.9%) | 5 |
Limitations/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
| Name/Title | Medical Director Endocrinology |
|---|---|
| Organization | Ipsen |
| Phone | clinical.trials@ipsen.com |
| clinical.trials@ipsen.com |
Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT00353496
Other Study ID Numbers:
- 2-55-52030-726
- 2005-004904-35
First Posted:
Jul 18, 2006
Last Update Posted:
Mar 6, 2015
Last Verified:
Feb 1, 2015