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Trial record 27 of 34 for:    Lanreotide | Neuroendocrine Tumors

An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome (ELECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00774930
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : February 9, 2016
Last Update Posted : January 14, 2019
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 Carcinoid Syndrome
Interventions Drug: Lanreotide
Drug: Placebo
Enrollment 115
Recruitment Details Subjects were recruited from multiple sites across countries from May 2009. The study was completed in December 2015.
Pre-assignment Details A total of 153 subjects were screened; 115 were randomized and 38 failed screening.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase. Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
Period Title: DB Phase
Started 59 [1] 56 [1]
Completed 45 [2] 34 [3]
Not Completed 14 22
Reason Not Completed
Early Roll Over (ERO) to IOL phase             11             12
Adverse Event             1             2
Subject Decision             1             5
Sponsor Decision             0             1
Disease Progression             1             1
Started Nonprotocol Radiation therapy             0             1
[1]
One subject was randomised to receive lanreotide Autogel, but erroneously received placebo.
[2]
Received 4 DB study injections AND continued to IOL phase OR
[3]
had diary data at least up to day 21 after 4th dose, regardless of missing diary data before day 21.
Period Title: IOL Phase
Started 56 46 [1]
Completed 43 37
Not Completed 13 9
Reason Not Completed
Adverse Event             1             1
Subject Decision             4             3
Physician Decision             3             2
Sponsor Decision             1             0
Disease Progression             2             1
Subject Consumed Prohibited Medication             1             0
Peptide Receptor Radionuclide Therapy             0             1
Other             1             0
Brain radiation             0             1
[1]
Includes 1 subject listed as completing and withdrawing from the DB phase due to brain radiation
Period Title: LTOLE Phase
Started 32 [1] 25 [2]
Completed 17 8
Not Completed 15 17
Reason Not Completed
Adverse Event             7             3
Subject decision             0             5
Physician Decision             4             1
Sponsor decision             2             1
Disease Progression             2             5
Tumour Progression of Hepatic Metastases             0             1
Proton Pump Inhibitor Dose Adjusted             0             1
[1]
24 subjects from IOL did not enter LTOLE (11 completed IOL, 13 did not complete IOL).
[2]
20 subjects from IOL did not enter LTOLE (12 completed IOL, 8 did not complete IOL).
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo Total
Hide Arm/Group Description Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group. Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Total of all reporting groups
Overall Number of Baseline Participants 59 56 115
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 56 participants 115 participants
57.9  (10.6) 59.3  (11.6) 58.6  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 56 participants 115 participants
Female
32
  54.2%
35
  62.5%
67
  58.3%
Male
27
  45.8%
21
  37.5%
48
  41.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 56 participants 115 participants
Asian 6 3 9
Black/African American 2 3 5
White 44 44 88
Multi race 7 6 13
1.Primary Outcome
Title Percentage of Days With Subcutaneous Octreotide as Rescue Medication
Hide Description Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.
Time Frame 16-week DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 59 56
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage of days
33.72
(25.02 to 42.42)
48.49
(39.57 to 57.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanreotide Autogel (Somatuline Depot) 120 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0165
Comments [Not Specified]
Method ANCOVA
Comments This analysis does not include any imputation for the early roll over subjects
2.Secondary Outcome
Title Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.
Hide Description [Not Specified]
Time Frame 16-week DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 59 56
Mean (Standard Deviation)
Unit of Measure: Number of events per day
1.56  (1.83) 1.35  (1.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanreotide Autogel (Somatuline Depot) 120 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2544
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA included treatment group and 2 stratification variables at randomisation as factors and average frequency of diarrhoea per day during Screening
3.Secondary Outcome
Title Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.
Hide Description [Not Specified]
Time Frame 16-week DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 59 56
Mean (Standard Deviation)
Unit of Measure: Number of events per day
0.92  (1.45) 1.75  (2.26)
4.Secondary Outcome
Title Percentage of Days of Use of Other Rescue Medication
Hide Description Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).
Time Frame 16-week DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 59 56
Mean (Standard Deviation)
Unit of Measure: Percentage of days
8.86  (19.34) 6.25  (17.48)
5.Secondary Outcome
Title Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study
Hide Description Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.
Time Frame 16-week DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 59 56
Measure Type: Number
Unit of Measure: Percentage of subjects
18.6 21.4
6.Secondary Outcome
Title Changes From Baseline in "Global Health Status/Quality of Life (QoL)" Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)
Hide Description

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.

For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Time Frame Baseline and Week 12 of DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 48 34
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.17  (14.18) -1.72  (18.21)
7.Secondary Outcome
Title Changes From Baseline in “Gastrointestinal (G.I). Symptoms” Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]
Hide Description

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.

For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Time Frame Baseline and Week 12 of DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 48 33
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.06  (12.80) 0.10  (13.83)
8.Secondary Outcome
Title Changes From Baseline in QoL in “Endocrine Symptoms” Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)
Hide Description

Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.

For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS.

Time Frame Baseline and Week 12 of DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 48 33
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-6.83  (18.98) -2.69  (22.23)
9.Secondary Outcome
Title Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])
Hide Description Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.
Time Frame Baseline and Week 12 of DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 41 28
Mean (Standard Deviation)
Unit of Measure: μg/L
1125.8  (12579.4) 801.5  (2294.0)
10.Secondary Outcome
Title Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])
Hide Description Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.
Time Frame Baseline and Week 12 of DB phase
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg Placebo
Hide Arm/Group Description:
Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
Overall Number of Participants Analyzed 39 27
Mean (Standard Deviation)
Unit of Measure: μmol/day
-201.4  (1009.9) 36.3  (142.3)
Time Frame Adverse events (AEs) were collected from the time the subject signed informed consent to the exit visit (up to 16 weeks of DB phase, 32 weeks of IOL phase and every 4 subsequent weeks in the LTOLE phase until at least 2 years after the last subject completed the IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome was obtained [whichever occurred first]).
Adverse Event Reporting Description

Safety population: All randomised subjects who received at least 1 injection of study treatment; subjects were analysed under the actual treatment received. For placebo group (DB phase) n=57 as 1 subject was randomised to lanreotide Autogel but erroneously received placebo.

Treatment-emergent AEs (TEAEs) reported in the IOL or LTOLE phases are AEs that were either not present or were of moderate or severe intensity prior to the first dose of lanreotide Autogel during that phase.

 
Arm/Group Title Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) Placebo (DB Phase) Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)
Hide Arm/Group Description Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase). All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
All-Cause Mortality
Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) Placebo (DB Phase) Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) Placebo (DB Phase) Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/58 (3.45%)      5/57 (8.77%)      8/101 (7.92%)      15/57 (26.32%)    
Cardiac disorders         
Pericardial effusion  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  3 0/57 (0.00%)  0
Ear and labyrinth disorders         
Deafness permanent  1  1/58 (1.72%)  1 0/57 (0.00%)  0 0/101 (0.00%)  0 0/57 (0.00%)  0
Gastrointestinal disorders         
Small intestinal obstruction  1  1/58 (1.72%)  3 0/57 (0.00%)  0 3/101 (2.97%)  4 0/57 (0.00%)  0
Vomiting  1  0/58 (0.00%)  0 1/57 (1.75%)  2 0/101 (0.00%)  0 1/57 (1.75%)  1
Abdominal pain  1  0/58 (0.00%)  0 1/57 (1.75%)  1 0/101 (0.00%)  0 1/57 (1.75%)  1
Diarrhoea  1  0/58 (0.00%)  0 1/57 (1.75%)  1 0/101 (0.00%)  0 0/57 (0.00%)  0
Intestinal obstruction  1  0/58 (0.00%)  0 1/57 (1.75%)  1 0/101 (0.00%)  0 0/57 (0.00%)  0
Subileus  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
General disorders         
Disease progression  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 0/57 (0.00%)  0
Death  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
General physical health deterioration  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Pyrexia  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Infections and infestations         
Urinary tract infection  1  1/58 (1.72%)  1 1/57 (1.75%)  1 0/101 (0.00%)  0 1/57 (1.75%)  1
Kidney infection  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 1/57 (1.75%)  1
Lower respiratory tract infection  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 0/57 (0.00%)  0
Urosepsis  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 1/57 (1.75%)  1
Sepsis  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 2/57 (3.51%)  2
Pyelonephritis  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Pyelonephritis acute  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Infection  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Injury, poisoning and procedural complications         
Femur fracture  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Patella fracture  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Metabolism and nutrition disorders         
Hyperglycaemia  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Glucose tolerance impaired  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  2
Musculoskeletal and connective tissue disorders         
Back pain  1  0/58 (0.00%)  0 1/57 (1.75%)  1 0/101 (0.00%)  0 0/57 (0.00%)  0
Pain in extremity  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 0/57 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Invasive ductal breast carcinoma  1  1/58 (1.72%)  1 0/57 (0.00%)  0 0/101 (0.00%)  0 0/57 (0.00%)  0
Metastases to central nervous system  1  0/58 (0.00%)  0 1/57 (1.75%)  1 0/101 (0.00%)  0 0/57 (0.00%)  0
Metastases to liver  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 0/57 (0.00%)  0
Metastases to pleura  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 0/57 (0.00%)  0
Metastases to spine  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 0/57 (0.00%)  0
Tumour necrosis  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  2
Malignant neoplasm progression  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 2/57 (3.51%)  2
Pancreatic carcinoma  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Nervous system disorders         
Cerebral ischaemia  1  0/58 (0.00%)  0 1/57 (1.75%)  1 0/101 (0.00%)  0 0/57 (0.00%)  0
Hydrocephalus  1  0/58 (0.00%)  0 1/57 (1.75%)  1 0/101 (0.00%)  0 0/57 (0.00%)  0
Dizziness  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Sciatica  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Syncope  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Psychiatric disorders         
Mental status changes  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 0/57 (0.00%)  0
Renal and urinary disorders         
Ureteric stenosis  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 1/57 (1.75%)  1
Respiratory, thoracic and mediastinal disorders         
Bronchospasm  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 0/57 (0.00%)  0
Pneumonia aspiration  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Pneumothorax  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 1/57 (1.75%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase) Placebo (DB Phase) Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase) Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/58 (53.45%)      34/57 (59.65%)      71/101 (70.30%)      46/57 (80.70%)    
Blood and lymphatic system disorders         
Anaemia  1  0/58 (0.00%)  0 0/57 (0.00%)  0 4/101 (3.96%)  4 6/57 (10.53%)  7
Gastrointestinal disorders         
Nausea  1  5/58 (8.62%)  5 5/57 (8.77%)  5 8/101 (7.92%)  9 4/57 (7.02%)  5
Vomiting  1  4/58 (6.90%)  6 2/57 (3.51%)  2 6/101 (5.94%)  6 5/57 (8.77%)  8
Abdominal pain  1  5/58 (8.62%)  5 7/57 (12.28%)  7 11/101 (10.89%)  14 13/57 (22.81%)  25
Abdominal pain upper  1  1/58 (1.72%)  1 1/57 (1.75%)  1 4/101 (3.96%)  4 7/57 (12.28%)  9
Constipation  1  2/58 (3.45%)  2 2/57 (3.51%)  2 4/101 (3.96%)  5 5/57 (8.77%)  5
Diarrhoea  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 8/57 (14.04%)  10
Flatulence  1  3/58 (5.17%)  3 1/57 (1.75%)  2 3/101 (2.97%)  3 0/57 (0.00%)  0
General disorders         
Fatigue  1  2/58 (3.45%)  2 4/57 (7.02%)  4 10/101 (9.90%)  10 9/57 (15.79%)  14
Oedema peripheral  1  0/58 (0.00%)  0 3/57 (5.26%)  3 3/101 (2.97%)  3 3/57 (5.26%)  3
Pyrexia  1  1/58 (1.72%)  1 1/57 (1.75%)  1 1/101 (0.99%)  1 5/57 (8.77%)  6
Influenza like illness  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 3/57 (5.26%)  4
Disease progression  1  0/58 (0.00%)  0 0/57 (0.00%)  0 0/101 (0.00%)  0 5/57 (8.77%)  5
Asthenia  1  2/58 (3.45%)  2 1/57 (1.75%)  1 2/101 (1.98%)  2 6/57 (10.53%)  9
Hepatobiliary disorders         
Cholelithiasis  1  0/58 (0.00%)  0 1/57 (1.75%)  1 5/101 (4.95%)  5 4/57 (7.02%)  5
Infections and infestations         
Nasopharyngitis  1  2/58 (3.45%)  2 2/57 (3.51%)  2 1/101 (0.99%)  1 7/57 (12.28%)  7
Upper respiratory tract infection  1  0/58 (0.00%)  0 2/57 (3.51%)  2 3/101 (2.97%)  3 3/57 (5.26%)  3
Investigations         
Weight decreased  1  1/58 (1.72%)  1 0/57 (0.00%)  0 9/101 (8.91%)  9 0/57 (0.00%)  0
Blood creatine phosphokinase increased  1  0/58 (0.00%)  0 1/57 (1.75%)  1 2/101 (1.98%)  2 3/57 (5.26%)  3
Blood triglycerides increased  1  0/58 (0.00%)  0 0/57 (0.00%)  0 2/101 (1.98%)  2 4/57 (7.02%)  5
Gamma-glutamyltransferase increased  1  0/58 (0.00%)  0 0/57 (0.00%)  0 2/101 (1.98%)  2 5/57 (8.77%)  12
Aspartate aminotransferase increased  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 3/57 (5.26%)  4
Metabolism and nutrition disorders         
Hypoglycaemia  1  2/58 (3.45%)  2 1/57 (1.75%)  1 0/101 (0.00%)  0 3/57 (5.26%)  7
Decreased appetite  1  1/58 (1.72%)  1 1/57 (1.75%)  1 7/101 (6.93%)  8 5/57 (8.77%)  5
Hypertriglyceridaemia  1  1/58 (1.72%)  1 1/57 (1.75%)  1 2/101 (1.98%)  2 3/57 (5.26%)  4
Gout  1  0/58 (0.00%)  0 1/57 (1.75%)  1 0/101 (0.00%)  0 3/57 (5.26%)  4
Hyperglycaemia  1  0/58 (0.00%)  0 1/57 (1.75%)  1 4/101 (3.96%)  9 7/57 (12.28%)  12
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  3/58 (5.17%)  3 0/57 (0.00%)  0 6/101 (5.94%)  6 1/57 (1.75%)  1
Back pain  1  1/58 (1.72%)  1 4/57 (7.02%)  4 5/101 (4.95%)  5 8/57 (14.04%)  10
Arthralgia  1  0/58 (0.00%)  0 1/57 (1.75%)  1 7/101 (6.93%)  8 6/57 (10.53%)  9
Musculoskeletal pain  1  0/58 (0.00%)  0 1/57 (1.75%)  1 1/101 (0.99%)  1 4/57 (7.02%)  4
Pain in extremity  1  0/58 (0.00%)  0 1/57 (1.75%)  1 3/101 (2.97%)  3 4/57 (7.02%)  4
Intervertebral disc protrusion  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 3/57 (5.26%)  3
Nervous system disorders         
Headache  1  7/58 (12.07%)  7 3/57 (5.26%)  3 10/101 (9.90%)  15 5/57 (8.77%)  7
Dizziness  1  4/58 (6.90%)  4 0/57 (0.00%)  0 5/101 (4.95%)  5 2/57 (3.51%)  2
Psychiatric disorders         
Anxiety  1  0/58 (0.00%)  0 1/57 (1.75%)  1 3/101 (2.97%)  3 3/57 (5.26%)  3
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/58 (3.45%)  2 1/57 (1.75%)  1 3/101 (2.97%)  3 3/57 (5.26%)  3
Dyspnoea  1  0/58 (0.00%)  0 4/57 (7.02%)  4 6/101 (5.94%)  6 2/57 (3.51%)  2
Vascular disorders         
Hypertension  1  0/58 (0.00%)  0 1/57 (1.75%)  1 9/101 (8.91%)  10 5/57 (8.77%)  5
Flushing  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 3/57 (5.26%)  3
Hot flush  1  0/58 (0.00%)  0 0/57 (0.00%)  0 1/101 (0.99%)  1 3/57 (5.26%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
With permission from the Sponsor, each investigator may have published or reported data from their own subjects. The study data in aggregate are the property of the Sponsor and may not be published without permission of the Sponsor. The Sponsor is the final arbitrator of issues relating to the publication or presentation of the aggregate data.
Results Point of Contact
Name/Title: Medical Director, Oncology
Organization: Ipsen
Phone: clinical.trials@ipsen.com
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00774930     History of Changes
Other Study ID Numbers: 2-55-52030-730
TR321 ( Other Identifier: Tercica Inc )
2010-019066-92 ( EudraCT Number )
First Submitted: October 15, 2008
First Posted: October 17, 2008
Results First Submitted: August 5, 2015
Results First Posted: February 9, 2016
Last Update Posted: January 14, 2019