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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: January 7, 2016
Last verified: December 2015
Results First Received: August 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Carcinoid Syndrome
Interventions: Drug: Somatuline Depot (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

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
154 participants screened, 115 were randomized and 39 excluded as they did not meet inclusion criteria

Reporting Groups
  Description
Lanreotide (Somatuline Depot) 120 mg Lanreotide Autogel 120 mg subcutaneous injection every 4 weeks for 16 weeks (DB phase), 32 weeks (IOL phase) and 2 years (LTOLE phase)
Placebo

Placebo subcutaneous injection every 4 weeks for 16 weeks (DB phase)

Lanreotide Autogel 120 mg subcutaneous (SC) injection every 4 weeks for 32 weeks (IOL phase) and 2 years (LTOLE phase)


Participant Flow for 3 periods

Period 1:   Double Blind (DB) Phase:
    Lanreotide (Somatuline Depot) 120 mg     Placebo  
STARTED     59     56  
COMPLETED     45 [1]   34 [2]
NOT COMPLETED     14     22  
Early rolled over to IOL phase                 11                 12  
Adverse Event                 1                 2  
Withdrawal by Subject                 1                 5  
Sponsor decision                 0                 1  
Unspecified                 1                 2  
[1] * Subjects who received 4 DB study injections AND rolled over into the IOL phase OR
[2] *had diary data at least up to day 21 after 4th DB SC regardless of missing diary data before day 21

Period 2:   Initial Open Label (IOL) Phase
    Lanreotide (Somatuline Depot) 120 mg     Placebo  
STARTED     56 [1]   45 [2]
COMPLETED     27     20  
NOT COMPLETED     29     25  
Ongoing in IOL phase                 18                 18  
Adverse Event                 1                 0  
Withdrawal by Subject                 2                 3  
Physician Decision                 3                 2  
Sponsor decision                 1                 0  
Unspecified                 4                 2  
[1] 11 subjects continued to IOL phase [rolled over early from double blind (DB) phase]
[2] 12 subjects rolled over early from DB to IOL phase. 1 subject completed DB did not continue to IOL

Period 3:   LTOLE Phase
    Lanreotide (Somatuline Depot) 120 mg     Placebo  
STARTED     19 [1]   12 [2]
COMPLETED     0 [3]   0 [4]
NOT COMPLETED     19     12  
Ongoing in LTOLE phase                 17                 9  
Physician Decision                 1                 0  
Unspecified                 1                 3  
[1] 8 subjects completed IOL phase, did not continue to Long term open label extension (LTOLE) phase
[2] 8 subjects completed IOL phase, did not continue to LTOLE phase
[3] ** The date of data-cutoff for the first analysis was done at last patient last visit of DB phase.
[4] ** At this time, none of the patients had completed 2 years of treatment



  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 (Somatuline Depot) 120 mg Lanreotide Autogel 120 mg subcutaneous injection every 4 weeks for 16 weeks (DB phase), 32 weeks (IOL phase) and 2 years (LTOLE phase)
Placebo

Placebo subcutaneous injection every 4 weeks for 16 weeks (DB phase)

Lanreotide Autogel 120 mg subcutaneous injection every 4 weeks for 32 weeks (IOL phase) and 2 years (LTOLE phase)

Total Total of all reporting groups

Baseline Measures
    Lanreotide (Somatuline Depot) 120 mg     Placebo     Total  
Number of Participants  
[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]
     
Female     32     35     67  
Male     27     21     48  
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
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1.  Primary:   Percentage of Days That Subcutaneous Octreotide is Used as Rescue Medication   [ Time Frame: 16 week double-blind phase of the study ]

2.  Secondary:   Average Frequency of Diarrhea Events (Per Day) Based on Patient IVRS Diary Records.   [ Time Frame: 16-week double-blind phase ]

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

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

5.  Secondary:   Percentage of Subjects Who Roll Over Into the Open-label Phase Before Completing the Double-blind Phase of the Study   [ Time Frame: Week 16 ]

6.  Secondary:   Changes From Baseline in Global Health Status/Quality of Life (QoL) Scores [Based on Items 29 and 30 of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30]   [ Time Frame: Baseline and Week 12 double-blind phase ]

7.  Secondary:   Changes From Baseline in “G.I. Symptoms” Score [Assessed Based on Items Q34, Q35, Q36, Q37, Q38 of EORTC Gastrointestinal (GI) NET 21]   [ Time Frame: Baseline and Week 12 double blind phase ]

8.  Secondary:   Changes From Baseline in QoL in “Endocrine Symptoms” Score [Assessed Based on Items Q31, Q32, Q33 Using EORTC QLQ- G.I. Neuroendocrine Tumour (NET) 21 Questionnaires]   [ Time Frame: Baseline and Week 12 double blind phase ]

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

10.  Secondary:   Absolute Changes From Baseline in Biochemical Markers – Urinary 5-hydroxyindoleacetic Acid (5-HIAA)   [ Time Frame: Baseline and Week 12 double blind 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
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  More Information
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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
e-mail: 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 )
Study First Received: October 15, 2008
Results First Received: August 5, 2015
Last Updated: January 7, 2016
Health Authority: United States: Food and Drug Administration
Latvia: State Agency of Medicines
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
India: Drugs Controller General of India
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Ukraine: State Pharmacological Center - Ministry of Health
Brazil: National Health Surveillance Agency
Croatia: Ministry of Health and Social Care
Russia: Ministry of Health of the Russian Federation
Turkey: Ministry of Health