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

Primary Purpose

Carcinoid Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lanreotide
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoid Syndrome focused on measuring Carcinoid tumor, Somatuline Depot, Lanreotide Autogel, Neuroendocrine tumor, NET, Diarrhea, Flushing, Carcinoid tumour, Neuroendocrine tumour, Diarrhoea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Subjects were eligible for participation in the study if they met the following criteria:

  1. At least 18 years of age at the time of first dosing.
  2. Subjects must have given signed informed consent before any study related activities were conducted.
  3. Subjects in the United States of America (USA) must have given written authorisation for the release of protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations; subjects in other countries must have provided appropriate authorisation as needed by regulatory authorities in each country.
  4. Subjects must have been willing to receive s.c. octreotide injections as rescue medication, as needed to control their symptoms, if any.
  5. If female, the subject must not have been pregnant (confirmed by negative pregnancy test) and must have had the following documented via verbally given history:

    • At least 1 year postmenopausal (natural cessation of menses), or
    • Surgically sterile (if by tubal ligation, surgery must have been performed more than 3 months prior to entry into the study), or
    • If the subject was of childbearing potential and sexually active, she must have been using an acceptable form of contraception (oral, injected, transdermal or implanted contraceptives, diaphragm or barrier method with spermicidal and/or intrauterine device); local methods such as condoms or sponges/vaginal tablets were not acceptable forms of contraception.
  6. Subjects with a histopathologically confirmed diagnosis of carcinoid tumour or, a carcinoid tumour of unknown location with liver metastases (documented biopsy), and a history of carcinoid syndrome (flushing and/or diarrhoea) who were either naïve to treatment with a somatostatin analogue (SSTa) or responsive (according to the opinion of the principal investigator) to conventional doses of Sandostatin LAR® Depot (LAR; ≤30 mg every 4 weeks) or to daily doses of ≤600 μg of s.c. octreotide.
  7. Confirmation of positive somatostatin receptor (SSTR) status by somatostatin receptor scintigraphy (SRS; up to 6 months prior to study entry at the Screening Visit).
  8. Absence of tumour progression documented by two sequential computed tomography (CT) scans or two sequential magnetic resonance imaging (MRI) scans (≥3 months apart); the last CT or MRI scan must have been performed within 6 months of study entry (Screening Visit).
  9. Subjects previously treated with LAR, must have received their last dose of LAR at least 4 weeks prior to first dose of study treatment (no later than at the Screening Visit).
  10. Be able to communicate and cooperate with the principal investigator and the staff and willing to comply with the study instructions.

Subjects were excluded from entering the study for the following reasons:

  1. History of known allergy or hypersensitivity to investigational drug or any components of its formulation, or octreotide.
  2. History of carcinoid syndrome refractory to treatment with conventional doses of SSTa.
  3. Treatment with any other investigational drug within 30 days prior to study entry (Screening Visit) and/or at any time during the subject's participation in the study.
  4. Treatment with interferon, chemotherapy and/or radiotherapy (a radiolabelled SSTa) and/or tumour debulking <3 months prior to study entry (Screening Visit).
  5. History of hepatic arterial embolisation, hepatic arterial chemoembolisation and/or selective internal radiation therapy (selective internal radiation [SIR] therapy [SIRT]; e.g. SIR Spheres) <6 months prior to study entry (Screening Visit).
  6. Short bowel syndrome.
  7. Uncontrolled diabetes and/or hypertension.
  8. Severe renal impairment (glomerular filtration rate <30 mL/min/1.73 m2) and/or severe liver impairment as evidenced by serum total bilirubin >1.5 mg/dL associated with bile duct blockage or with alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5.0 upper limit of normal (ULN).
  9. Diagnosis of cardiac disease New York Heart Association (NYHA) functional classification >Class I. (Subject has limitation of physical activity. Ordinary physical activity causes undue fatigue, palpitation, or dyspnoea).
  10. Life expectancy less than 1 year.
  11. Any malignancies except carcinoid tumour, basocellular carcinoma of the skin, in situ carcinoma of the cervix and ≥5 years disease free after curative cancer treatment.
  12. Any serious medical condition that could jeopardise the safety of the subject and/or the efficacy assessments of the study.
  13. Subject is being treated with a proton pump inhibitor (PPI) and has been at a stable dose (no change in dose or frequency of administration) for less than 4 weeks at study entry (Screening Visit).

Sites / Locations

  • VA Greater Los Angeles Health Care System
  • David Geffen School of Medicine at UCLA
  • Stanford Cancer Center
  • Cedars Sinai Outpatient Cancer Center
  • Kentuckiana Cancer Institute
  • Louisiana State University Health Science Center
  • University of Michigan
  • University of Mississippi Medical Center
  • University of New Mexico Cancer Care Center
  • Providence Portland Medical Center
  • Oregon Health Science University
  • Penn State Milton S. Hershey Medical Center
  • University of Pennsylvania
  • UPMC Liver Cancer Center
  • Eastern Virginia Medical School
  • Froedtert & Medical College of Wisconsin
  • Biocancer - Centro de Pesquisa e Tratamento do Câncer
  • Hospital LifeCenter
  • Oxion Medicina Oncológica
  • Hospital Universitário de Brasilia
  • Hospital Erasto Gaertner
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Hospital de Base de São José do Rio Preto
  • VFN Onkologicka klinika
  • Sir Gangaram Hospital
  • Indo-American Cancer Institute & Research Centre
  • Omega Hospitals
  • Santokaba Durlabhji Memorial Hospital and Research Institute
  • Bhagwan Mahaveer cancer hospital and research centre
  • Shatabdi Super Speciality hospital
  • Tata Memorial Hospital
  • Paul Stradins Clinical University Hospital
  • Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
  • Non-Federal Institution of Healthcare "Central Clinical Hospital # 1 of the LLC "Russian Railways (RZD)"
  • Russian Academy of Medical Sciences "Russian Oncological Research Centre named after N.N. Blokhin RAMS"
  • Federal Institution of Healthcare "Leningradsky Regional Oncological Dispensary"
  • Clinic of Endocrinology, diabetes and metabolic diseases, Clinical Center of Serbia
  • Oncology Institute of Vojvodina, Sremska Kamenica
  • Rondebosch Oncology Unit
  • Groote Schuur Hospital
  • Westridge Medical Centre
  • GVI Oncology Clinical Trial Unit
  • Erciyes University Medical Faculty
  • Cherkassy Regional Oncology Dispensary
  • Chernivtsi Regional Oncology Center
  • Oncology and Medical Radiology Chair of Dnepropetrovsk State Medical Academy
  • Regional Anticancer Center, Department of oncoproctology
  • Municipal Clinical Hospital #2, Proctology department
  • Kyiv City Oncological Hospital, Thoracic department
  • Medical Centre "Mriya"
  • National Cancer Institute
  • Odessa Regional Clinical Hospital
  • Uzhgorods'ka Tsentral'na Mis'ka Klinichna Likarnya, Mis'kyy Onkologichnyy Tsentr
  • Vinnytsya Regional Clinical Oncological Center, Vinnytsya State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lanreotide Autogel (Somatuline Depot) 120 mg

Placebo (DB) and lanreotide Autogel 120 mg in IOL and LTOLE

Arm Description

Subjects received deep s.c. lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). After completing the DB phase (or if they met criteria for early roll over [ERO]) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks 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]).

Subjects received deep s.c. placebo every 4 weeks (±3 days) for 16 weeks (DB phase). After completing the DB phase (or if they met criteria for ERO) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks 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]).

Outcomes

Primary Outcome Measures

Percentage of Days With Subcutaneous Octreotide as Rescue Medication
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.

Secondary Outcome Measures

Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.
Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.
Percentage of Days of Use of Other Rescue Medication
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).
Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study
Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.
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)
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.
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]
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.
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)
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.
Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])
Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.
Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])
Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.

Full Information

First Posted
October 15, 2008
Last Updated
September 15, 2022
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00774930
Brief Title
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
Acronym
ELECT
Official Title
A Double Blind, Randomized Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to determine whether monthly deep subcutaneous (s.c.) injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling diarrhoea and flushing by reducing the usage of s.c. short-acting octreotide as a rescue medication to control symptoms in subjects with carcinoid syndrome.
Detailed Description
This study consisted of a Screening period, conducted up to 4 months before randomisation, followed by three phases: a 16-week, double blind (DB), randomised, placebo-controlled phase; a 32-week initial open label (IOL) phase; and a long term open label extension (LTOLE) phase. The DB phase evaluated lanreotide Autogel versus placebo in subjects with a history of carcinoid syndrome (flushing and/or diarrhoea). This was followed by a 32-week IOL phase in which all subjects received lanreotide Autogel 120 mg every 4 weeks. Subjects in countries where lanreotide Autogel had not been approved for the treatment of carcinoid syndrome, who were well-controlled at the end of the 32-week IOL phase and chose to continue to receive lanreotide Autogel, were given the option of participating in a LTOLE phase. The LTOLE phase of the study was planned to end at least 2 years after the last subject had completed his/her participation in the 32-week IOL phase or when marketing approval for the treatment of symptoms of carcinoid syndrome had been obtained in the respective countries (whichever occurred first) or at any time the study was terminated by the Sponsor. The actual overall duration of the study was 6.5 years. During the LTOLE phase all subjects continued to be treated with lanreotide Autogel 120 mg every 4 weeks. The study planned to enrol approximately 100 adult subjects worldwide. Screening continued until 115 subjects were enrolled in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Syndrome
Keywords
Carcinoid tumor, Somatuline Depot, Lanreotide Autogel, Neuroendocrine tumor, NET, Diarrhea, Flushing, Carcinoid tumour, Neuroendocrine tumour, Diarrhoea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanreotide Autogel (Somatuline Depot) 120 mg
Arm Type
Experimental
Arm Description
Subjects received deep s.c. lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). After completing the DB phase (or if they met criteria for early roll over [ERO]) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks 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]).
Arm Title
Placebo (DB) and lanreotide Autogel 120 mg in IOL and LTOLE
Arm Type
Placebo Comparator
Arm Description
Subjects received deep s.c. placebo every 4 weeks (±3 days) for 16 weeks (DB phase). After completing the DB phase (or if they met criteria for ERO) the subjects entered the IOL phase during which they received lanreotide Autogel 120 mg deep s.c. every 4 weeks for 32 weeks. During the LTOLE phase, subjects continued treatment with lanreotide Autogel 120 mg deep s.c. every 4 weeks 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]).
Intervention Type
Drug
Intervention Name(s)
Lanreotide
Other Intervention Name(s)
Somatuline, Somatuline Depot, Somatuline Autogel, Lanreotide Autogel
Intervention Description
deep s.c. injection, 120 mg, every 4 weeks (±3 days).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
deep s.c. injection of placebo (0.9% saline solution) every 4 weeks (±3 days) for 16 weeks, then deep s.c. injection of lanreotide 120 mg, every 4 weeks (±3 days).
Primary Outcome Measure Information:
Title
Percentage of Days With Subcutaneous Octreotide as Rescue Medication
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
Secondary Outcome Measure Information:
Title
Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.
Time Frame
16-week DB phase
Title
Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.
Time Frame
16-week DB phase
Title
Percentage of Days of Use of Other Rescue Medication
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
Title
Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study
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
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)
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
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]
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
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)
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
Title
Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])
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
Title
Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects were eligible for participation in the study if they met the following criteria: At least 18 years of age at the time of first dosing. Subjects must have given signed informed consent before any study related activities were conducted. Subjects in the United States of America (USA) must have given written authorisation for the release of protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations; subjects in other countries must have provided appropriate authorisation as needed by regulatory authorities in each country. Subjects must have been willing to receive s.c. octreotide injections as rescue medication, as needed to control their symptoms, if any. If female, the subject must not have been pregnant (confirmed by negative pregnancy test) and must have had the following documented via verbally given history: At least 1 year postmenopausal (natural cessation of menses), or Surgically sterile (if by tubal ligation, surgery must have been performed more than 3 months prior to entry into the study), or If the subject was of childbearing potential and sexually active, she must have been using an acceptable form of contraception (oral, injected, transdermal or implanted contraceptives, diaphragm or barrier method with spermicidal and/or intrauterine device); local methods such as condoms or sponges/vaginal tablets were not acceptable forms of contraception. Subjects with a histopathologically confirmed diagnosis of carcinoid tumour or, a carcinoid tumour of unknown location with liver metastases (documented biopsy), and a history of carcinoid syndrome (flushing and/or diarrhoea) who were either naïve to treatment with a somatostatin analogue (SSTa) or responsive (according to the opinion of the principal investigator) to conventional doses of Sandostatin LAR® Depot (LAR; ≤30 mg every 4 weeks) or to daily doses of ≤600 μg of s.c. octreotide. Confirmation of positive somatostatin receptor (SSTR) status by somatostatin receptor scintigraphy (SRS; up to 6 months prior to study entry at the Screening Visit). Absence of tumour progression documented by two sequential computed tomography (CT) scans or two sequential magnetic resonance imaging (MRI) scans (≥3 months apart); the last CT or MRI scan must have been performed within 6 months of study entry (Screening Visit). Subjects previously treated with LAR, must have received their last dose of LAR at least 4 weeks prior to first dose of study treatment (no later than at the Screening Visit). Be able to communicate and cooperate with the principal investigator and the staff and willing to comply with the study instructions. Subjects were excluded from entering the study for the following reasons: History of known allergy or hypersensitivity to investigational drug or any components of its formulation, or octreotide. History of carcinoid syndrome refractory to treatment with conventional doses of SSTa. Treatment with any other investigational drug within 30 days prior to study entry (Screening Visit) and/or at any time during the subject's participation in the study. Treatment with interferon, chemotherapy and/or radiotherapy (a radiolabelled SSTa) and/or tumour debulking <3 months prior to study entry (Screening Visit). History of hepatic arterial embolisation, hepatic arterial chemoembolisation and/or selective internal radiation therapy (selective internal radiation [SIR] therapy [SIRT]; e.g. SIR Spheres) <6 months prior to study entry (Screening Visit). Short bowel syndrome. Uncontrolled diabetes and/or hypertension. Severe renal impairment (glomerular filtration rate <30 mL/min/1.73 m2) and/or severe liver impairment as evidenced by serum total bilirubin >1.5 mg/dL associated with bile duct blockage or with alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5.0 upper limit of normal (ULN). Diagnosis of cardiac disease New York Heart Association (NYHA) functional classification >Class I. (Subject has limitation of physical activity. Ordinary physical activity causes undue fatigue, palpitation, or dyspnoea). Life expectancy less than 1 year. Any malignancies except carcinoid tumour, basocellular carcinoma of the skin, in situ carcinoma of the cervix and ≥5 years disease free after curative cancer treatment. Any serious medical condition that could jeopardise the safety of the subject and/or the efficacy assessments of the study. Subject is being treated with a proton pump inhibitor (PPI) and has been at a stable dose (no change in dose or frequency of administration) for less than 4 weeks at study entry (Screening Visit).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
VA Greater Los Angeles Health Care System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Cedars Sinai Outpatient Cancer Center
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University Health Science Center
City
Kenner
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of New Mexico Cancer Care Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
97239
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Liver Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Froedtert & Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Biocancer - Centro de Pesquisa e Tratamento do Câncer
City
Belo Horizonte
Country
Brazil
Facility Name
Hospital LifeCenter
City
Belo Horizonte
Country
Brazil
Facility Name
Oxion Medicina Oncológica
City
Belo Horizonte
Country
Brazil
Facility Name
Hospital Universitário de Brasilia
City
Brasilia
Country
Brazil
Facility Name
Hospital Erasto Gaertner
City
Curitiba
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Hospital de Base de São José do Rio Preto
City
São José do Rio Preto
Country
Brazil
Facility Name
VFN Onkologicka klinika
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Sir Gangaram Hospital
City
Delhi
Country
India
Facility Name
Indo-American Cancer Institute & Research Centre
City
Hyderabad
Country
India
Facility Name
Omega Hospitals
City
Hyderabad
Country
India
Facility Name
Santokaba Durlabhji Memorial Hospital and Research Institute
City
Jaipur
ZIP/Postal Code
302015
Country
India
Facility Name
Bhagwan Mahaveer cancer hospital and research centre
City
Jaipur
Country
India
Facility Name
Shatabdi Super Speciality hospital
City
Mumbai
ZIP/Postal Code
422005
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
Country
India
Facility Name
Paul Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Non-Federal Institution of Healthcare "Central Clinical Hospital # 1 of the LLC "Russian Railways (RZD)"
City
Moscow
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences "Russian Oncological Research Centre named after N.N. Blokhin RAMS"
City
Moscow
Country
Russian Federation
Facility Name
Federal Institution of Healthcare "Leningradsky Regional Oncological Dispensary"
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Clinic of Endocrinology, diabetes and metabolic diseases, Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Oncology Institute of Vojvodina, Sremska Kamenica
City
Sremska Kamenica
ZIP/Postal Code
21 204
Country
Serbia
Facility Name
Rondebosch Oncology Unit
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Groote Schuur Hospital
City
Cape Town
Country
South Africa
Facility Name
Westridge Medical Centre
City
Durban
Country
South Africa
Facility Name
GVI Oncology Clinical Trial Unit
City
Port Elizabeth
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Erciyes University Medical Faculty
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Cherkassy Regional Oncology Dispensary
City
Cherkassy
Country
Ukraine
Facility Name
Chernivtsi Regional Oncology Center
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Oncology and Medical Radiology Chair of Dnepropetrovsk State Medical Academy
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Regional Anticancer Center, Department of oncoproctology
City
Donetsk
Country
Ukraine
Facility Name
Municipal Clinical Hospital #2, Proctology department
City
Kharkiv
Country
Ukraine
Facility Name
Kyiv City Oncological Hospital, Thoracic department
City
Kyiv
Country
Ukraine
Facility Name
Medical Centre "Mriya"
City
Kyiv
Country
Ukraine
Facility Name
National Cancer Institute
City
Kyiv
Country
Ukraine
Facility Name
Odessa Regional Clinical Hospital
City
Odessa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
Uzhgorods'ka Tsentral'na Mis'ka Klinichna Likarnya, Mis'kyy Onkologichnyy Tsentr
City
Uzhgorod
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Oncological Center, Vinnytsya State Medical University
City
Vinnytsya
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
IPD Sharing Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/
Citations:
PubMed Identifier
27214300
Citation
Vinik AI, Wolin EM, Liyanage N, Gomez-Panzani E, Fisher GA; ELECT Study Group *. EVALUATION OF LANREOTIDE DEPOT/AUTOGEL EFFICACY AND SAFETY AS A CARCINOID SYNDROME TREATMENT (ELECT): A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL. Endocr Pract. 2016 Sep;22(9):1068-80. doi: 10.4158/EP151172.OR. Epub 2016 May 23.
Results Reference
result
PubMed Identifier
31754316
Citation
Blot K, Duchateau L, Lescrauwaet B, Liyanage N, Ray D, Mirakhur B, Vinik AI. A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial. Patient Relat Outcome Meas. 2019 Oct 29;10:335-343. doi: 10.2147/PROM.S219982. eCollection 2019.
Results Reference
derived

Learn more about this trial

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

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