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Trial record 28 of 34 for:    Lanreotide | Neuroendocrine Tumors

Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour (NET729)

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: NCT00842348
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : February 17, 2017
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Functioning Entero-pancreatic Endocrine Tumour
Intervention Drug: lanreotide (Autogel formulation)
Enrollment 89
Recruitment Details There were 26 active sites across 10 countries in Study 729; however, only 24 recruited patients. The study was initiated in February 2009 and was completed in December 2015.
Pre-assignment Details  
Arm/Group Title Lanreotide Autogel Placebo
Hide Arm/Group Description Patients who received lanreotide 120 mg (Autogel formulation) in the preceding double blind (DB) study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study. Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
Period Title: Patients Randomised in Study 726
Started 101 103
Completed 42 [1] 47 [2]
Not Completed 59 56
Reason Not Completed
Did not enter Study 729             59             56
[1]
41 patients had stable disease and 1 patient had progressive disease.
[2]
15 patients had stable disease and 32 patients had progressive disease.
Period Title: Study 729
Started 42 47
Completed 16 [1] 9 [1]
Not Completed 26 38
Reason Not Completed
Disease progression/death             19             30
Adverse Event             1             1
Protocol Violation             1             1
Withdrawal by Subject             2             4
Due to Sponsor stopping the study             1             1
Due to non-availability of IP             0             1
Sponsor's decision             1             0
Surgical resection             1             0
[1]
Enrolled in Study 729 and received at least one dose of open label lanreotide Autogel.
Arm/Group Title Lanreotide Autogel Placebo Total
Hide Arm/Group Description Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study. Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study. Total of all reporting groups
Overall Number of Baseline Participants 42 47 89
Hide Baseline Analysis Population Description
Safety Population: All patients who received at least one dose of lanreotide Autogel in Study 729.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 47 participants 89 participants
64.8  (10.8) 61.3  (10.2) 62.9  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 47 participants 89 participants
Female
23
  54.8%
22
  46.8%
45
  50.6%
Male
19
  45.2%
25
  53.2%
44
  49.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 47 participants 89 participants
Asian 0 3 3
Black or African American 1 0 1
Caucasian/White 41 44 85
1.Primary Outcome
Title Adverse Events
Hide Description

Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.

An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:

  • It was not present prior to receiving the first dose of study treatment in Study 729; or,
  • It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.

Adverse event data are presented in the AE section.

Time Frame Throughout the study until the completion/early discontinuation visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all patients who received at least one dose of lanreotide Autogel in Study 729.
Arm/Group Title Lanreotide Autogel Placebo Total
Hide Arm/Group Description:
Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
Patients who received placebo in the preceding double DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
All patients treated with Lanreotide 120 mg (Autogel formulation) in the open label study.
Overall Number of Participants Analyzed 42 47 89
Measure Type: Number
Unit of Measure: participants with any TEAEs
40 46 86
2.Secondary Outcome
Title Progression Free Survival (PFS): Kaplan-Meier Estimate
Hide Description

The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours [RECIST] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.

Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method.

Time Frame Throughout the study (every 24 weeks and at completion/withdrawal visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population: all patients randomised in the original protocol Study 726 (regardless of whether they continued into the extension Study 729). The ITT population was analysed using patients as randomised in Study 726.
Arm/Group Title Lanreotide Autogel - Randomised Treatment in Study 726 Placebo - Randomised Treatment in Study 726
Hide Arm/Group Description:
All patients randomised to lanreotide 120 mg (Autogel formulation) in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
All patients randomised to placebo in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
Overall Number of Participants Analyzed 101 103
Median (95% Confidence Interval)
Unit of Measure: weeks
154.14
(123.57 to 237.43)
72.00
(48.43 to 84.57)
Time Frame Adverse events were monitored from the time that the patient withdrew or completed Study 726 until withdrawal in Study 729.
Adverse Event Reporting Description Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. Local tolerance AEs were assessed by spontaneous reports. Any local tolerance assessed as present and judged as clinically significant was recorded as an AE in the CRF. Pre-existing conditions that worsened during the study were reported as AEs. Adverse events that were ongoing at the end of Study 726 were recorded and followed during Study 729.
 
Arm/Group Title Lanreotide Autogel Placebo Total
Hide Arm/Group Description Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study. Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study. All patients treated with lanreotide 120 mg (Autogel formulation) in the open label study.
All-Cause Mortality
Lanreotide Autogel Placebo Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lanreotide Autogel Placebo Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/42 (26.19%)      14/47 (29.79%)      25/89 (28.09%)    
Cardiac disorders       
Atrial fibrillation  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Restrictive cardiomyopathy  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Eye disorders       
Retinal vein occlusion  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Visual impairment  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Gastrointestinal disorders       
Abdominal adhesions  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Haematochezia  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Ileus  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Lower gastrointestinal haemorrhage  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Abdominal pain  1  0/42 (0.00%)  0 4/47 (8.51%)  5 4/89 (4.49%)  5
Abdominal pain upper  1  0/42 (0.00%)  0 2/47 (4.26%)  2 2/89 (2.25%)  2
Diarrhoea  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Intestinal obstruction  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Pancreatitis  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Small intestinal obstruction  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Vomiting  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
General disorders       
Fatigue  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Face oedema  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Oedema peripheral  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Sudden death  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Hepatobiliary disorders       
Cholelithiasis  1  2/42 (4.76%)  2 0/47 (0.00%)  0 2/89 (2.25%)  2
Infections and infestations       
Hepatitis viral  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Pneumonia  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Postoperative wound infection  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Injury, poisoning and procedural complications       
Anastomotic stenosis  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Fall  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Incisional hernia  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Post procedural haematoma  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Spinal compression fracture  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Metabolism and nutrition disorders       
Decreased appetite  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Electrolyte imbalance  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumour pain  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Bladder cancer  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Tumour necrosis  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Nervous system disorders       
Cerebral infarction  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Stroke in evolution  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Renal and urinary disorders       
Prerenal failure  1  1/42 (2.38%)  1 0/47 (0.00%)  0 1/89 (1.12%)  1
Reproductive system and breast disorders       
Ovarian cyst  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Respiratory, thoracic and mediastinal disorders       
Pleural effusion  1  0/42 (0.00%)  0 1/47 (2.13%)  1 1/89 (1.12%)  1
Vascular disorders       
Hypertension  1  1/42 (2.38%)  2 0/47 (0.00%)  0 1/89 (1.12%)  2
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 Placebo Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/42 (80.95%)      42/47 (89.36%)      76/89 (85.39%)    
Blood and lymphatic system disorders       
Anaemia  1  3/42 (7.14%)  3 3/47 (6.38%)  4 6/89 (6.74%)  7
Gastrointestinal disorders       
Diarrhoea  1  8/42 (19.05%)  28 15/47 (31.91%)  25 23/89 (25.84%)  53
Nausea  1  7/42 (16.67%)  15 6/47 (12.77%)  11 13/89 (14.61%)  26
Constipation  1  5/42 (11.90%)  8 4/47 (8.51%)  6 9/89 (10.11%)  14
Vomiting  1  7/42 (16.67%)  8 5/47 (10.64%)  11 12/89 (13.48%)  19
Abdominal pain  1  7/42 (16.67%)  7 7/47 (14.89%)  9 14/89 (15.73%)  16
Abdominal discomfort  1  3/42 (7.14%)  5 2/47 (4.26%)  3 5/89 (5.62%)  8
Dyspepsia  1  5/42 (11.90%)  5 2/47 (4.26%)  4 7/89 (7.87%)  9
Abdominal pain upper  1  3/42 (7.14%)  4 9/47 (19.15%)  9 12/89 (13.48%)  13
Abdominal distension  1  3/42 (7.14%)  3 4/47 (8.51%)  7 7/89 (7.87%)  10
Steatorrhoea  1  2/42 (4.76%)  2 5/47 (10.64%)  5 7/89 (7.87%)  7
Haemorrhoids  1  0/42 (0.00%)  0 3/47 (6.38%)  3 3/89 (3.37%)  3
Rectal haemorrhage  1  0/42 (0.00%)  0 4/47 (8.51%)  4 4/89 (4.49%)  4
General disorders       
Fatigue  1  5/42 (11.90%)  6 4/47 (8.51%)  6 9/89 (10.11%)  12
Oedema peripheral  1  3/42 (7.14%)  4 1/47 (2.13%)  1 4/89 (4.49%)  5
Injection site pain  1  1/42 (2.38%)  1 3/47 (6.38%)  3 4/89 (4.49%)  4
Asthenia  1  0/42 (0.00%)  0 4/47 (8.51%)  4 4/89 (4.49%)  4
Injection site nodule  1  0/42 (0.00%)  0 3/47 (6.38%)  3 3/89 (3.37%)  3
Pyrexia  1  0/42 (0.00%)  0 3/47 (6.38%)  5 3/89 (3.37%)  5
Hepatobiliary disorders       
Cholelithiasis  1  7/42 (16.67%)  10 7/47 (14.89%)  9 14/89 (15.73%)  19
Infections and infestations       
Bronchitis  1  3/42 (7.14%)  6 7/47 (14.89%)  7 10/89 (11.24%)  13
Upper respiratory tract infection  1  4/42 (9.52%)  6 1/47 (2.13%)  1 5/89 (5.62%)  7
Viral infection  1  4/42 (9.52%)  5 2/47 (4.26%)  2 6/89 (6.74%)  7
Sinusitis  1  3/42 (7.14%)  3 0/47 (0.00%)  0 3/89 (3.37%)  3
Urinary tract infection  1  2/42 (4.76%)  2 5/47 (10.64%)  6 7/89 (7.87%)  8
Nasopharyngitis  1  1/42 (2.38%)  1 4/47 (8.51%)  9 5/89 (5.62%)  10
Injury, poisoning and procedural complications       
Procedural pain  1  1/42 (2.38%)  1 3/47 (6.38%)  6 4/89 (4.49%)  7
Investigations       
Weight decreased  1  1/42 (2.38%)  1 3/47 (6.38%)  5 4/89 (4.49%)  6
Metabolism and nutrition disorders       
Decreased appetite  1  4/42 (9.52%)  5 4/47 (8.51%)  5 8/89 (8.99%)  10
Hyperglycaemia  1  3/42 (7.14%)  3 1/47 (2.13%)  1 4/89 (4.49%)  4
Diabetes mellitus  1  2/42 (4.76%)  2 4/47 (8.51%)  4 6/89 (6.74%)  6
Hypokalaemia  1  0/42 (0.00%)  0 4/47 (8.51%)  5 4/89 (4.49%)  5
Musculoskeletal and connective tissue disorders       
Arthralgia  1  4/42 (9.52%)  6 6/47 (12.77%)  12 10/89 (11.24%)  18
Back pain  1  3/42 (7.14%)  3 6/47 (12.77%)  10 9/89 (10.11%)  13
Neck pain  1  3/42 (7.14%)  3 1/47 (2.13%)  1 4/89 (4.49%)  4
Myalgia  1  0/42 (0.00%)  0 3/47 (6.38%)  4 3/89 (3.37%)  4
Osteoporosis  1  0/42 (0.00%)  0 3/47 (6.38%)  3 3/89 (3.37%)  3
Nervous system disorders       
Dizziness  1  4/42 (9.52%)  6 2/47 (4.26%)  2 6/89 (6.74%)  8
Headache  1  2/42 (4.76%)  2 4/47 (8.51%)  4 6/89 (6.74%)  6
Psychiatric disorders       
Insomnia  1  4/42 (9.52%)  5 0/47 (0.00%)  0 4/89 (4.49%)  5
Renal and urinary disorders       
Haematuria  1  3/42 (7.14%)  3 0/47 (0.00%)  0 3/89 (3.37%)  3
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/42 (7.14%)  3 3/47 (6.38%)  6 6/89 (6.74%)  9
Oropharyngeal pain  1  3/42 (7.14%)  3 2/47 (4.26%)  3 5/89 (5.62%)  6
Dyspnoea  1  0/42 (0.00%)  0 3/47 (6.38%)  3 3/89 (3.37%)  3
Skin and subcutaneous tissue disorders       
Rash  1  5/42 (11.90%)  6 2/47 (4.26%)  3 7/89 (7.87%)  9
Dry skin  1  3/42 (7.14%)  5 2/47 (4.26%)  2 5/89 (5.62%)  7
Pruritus  1  1/42 (2.38%)  1 3/47 (6.38%)  5 4/89 (4.49%)  6
Vascular disorders       
Hypertension  1  4/42 (9.52%)  4 5/47 (10.64%)  5 9/89 (10.11%)  9
Flushing  1  1/42 (2.38%)  1 3/47 (6.38%)  5 4/89 (4.49%)  6
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.
The Sponsor required reasonable opportunity to review any abstract, presentation, or paper before the material is submitted for publication or communicated. This also applied to any amendments that are requested by referees or journal editors. The Sponsor committed to comment on the draft documents within a time period agreed in the contractual arrangements between the Sponsor and authors or their institution. Delays were also possible if publication would adversely affect patentability.
Results Point of Contact
Name/Title: Medical Director, Oncology
Organization: Ipsen
Phone: clinical.trials@ipsen.com
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00842348     History of Changes
Other Study ID Numbers: 2-55-52030-729
2008-004019-36 ( EudraCT Number )
First Submitted: February 11, 2009
First Posted: February 12, 2009
Results First Submitted: December 28, 2016
Results First Posted: February 17, 2017
Last Update Posted: January 14, 2019