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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00774930
First received: October 15, 2008
Last updated: December 28, 2016
Last verified: December 2016
Results First Received: August 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Carcinoid Syndrome
Interventions: Drug: Lanreotide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from multiple sites across countries from May 2009. The study was completed in December 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 153 subjects were screened; 115 were randomized and 38 failed screening.

Reporting Groups
  Description
Lanreotide Autogel (Somatuline Depot) 120 mg 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.
Placebo 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.

Participant Flow for 3 periods

Period 1:   DB Phase
    Lanreotide Autogel (Somatuline Depot) 120 mg   Placebo
STARTED   59 [1]   56 [1] 
COMPLETED   45 [2]   34 [3] 
NOT COMPLETED   14   22 
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 2:   IOL Phase
    Lanreotide Autogel (Somatuline Depot) 120 mg   Placebo
STARTED   56   46 [1] 
COMPLETED   43   37 
NOT COMPLETED   13   9 
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 
Unspecified                1                0 
Brain radiation                0                1 
[1] Includes 1 subject listed as completing and withdrawing from the DB phase due to brain radiation

Period 3:   LTOLE Phase
    Lanreotide Autogel (Somatuline Depot) 120 mg   Placebo
STARTED   32 [1]   25 [2] 
COMPLETED   17   8 
NOT COMPLETED   15   17 
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).



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Lanreotide Autogel (Somatuline Depot) 120 mg 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.
Placebo 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 Total of all reporting groups

Baseline Measures
   Lanreotide Autogel (Somatuline Depot) 120 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 59   56   115 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.9  (10.6)   59.3  (11.6)   58.6  (11.1) 
Gender 
[Units: Participants]
Count of Participants
     
Female      32  54.2%      35  62.5%      67  58.3% 
Male      27  45.8%      21  37.5%      48  41.7% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   6   3   9 
Black/African American   2   3   5 
White   44   44   88 
Multi race   7   6   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Days With Subcutaneous Octreotide as Rescue Medication   [ Time Frame: 16-week DB phase ]

2.  Secondary:   Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.   [ Time Frame: 16-week DB phase ]

3.  Secondary:   Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.   [ Time Frame: 16-week DB phase ]

4.  Secondary:   Percentage of Days of Use of Other Rescue Medication   [ Time Frame: 16-week DB phase ]

5.  Secondary:   Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study   [ Time Frame: 16-week DB phase ]

6.  Secondary:   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)   [ Time Frame: Baseline and Week 12 of DB phase ]

7.  Secondary:   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]   [ Time Frame: Baseline and Week 12 of DB phase ]

8.  Secondary:   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)   [ Time Frame: Baseline and Week 12 of DB phase ]

9.  Secondary:   Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])   [ Time Frame: Baseline and Week 12 of DB phase ]

10.  Secondary:   Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])   [ Time Frame: Baseline and Week 12 of DB phase ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None specified.


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director, Oncology
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com


Publications of Results:

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 )
Study First Received: October 15, 2008
Results First Received: August 5, 2015
Last Updated: December 28, 2016