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

NCT00774930 | Completed Phase 3 Results DMC

• 3 other identifiers: 2-55-52030-730TR3212010-019066-92
• Study Type: interventional
• Target: 115
• Locations: 11 countries
• Sites: 54

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.

Conditions

Carcinoid Syndrome

Keywords

Carcinoid tumor; Somatuline Depot; Lanreotide Autogel; Neuroendocrine tumor; NET; Diarrhea; Flushing; Carcinoid tumour; Neuroendocrine tumour; Diarrhoea

Outcome Measures

Primary Outcomes (1)

• 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.

  16-week DB phase

Secondary Outcomes (9)

• Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.

  16-week DB phase

• Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.

  16-week DB phase

• Percentage of Days of Use of Other Rescue Medication

  16-week DB phase

• Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study

  16-week DB phase

• 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 and Week 12 of DB phase

Study Arms (2)

Lanreotide Autogel (Somatuline Depot) 120 mg

EXPERIMENTAL

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 \[whichever occurred first\]).

Drug: Lanreotide

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

PLACEBO COMPARATOR

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 \[whichever occurred first\]).

Drug: Placebo

Interventions

Lanreotide DRUG

deep s.c. injection, 120 mg, every 4 weeks (±3 days).

Also known as: Somatuline, Somatuline Depot, Somatuline Autogel, Lanreotide Autogel

Lanreotide Autogel (Somatuline Depot) 120 mg

Placebo DRUG

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (54)

VA Greater Los Angeles Health Care System

Los Angeles, California, 90073, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Cedars Sinai Outpatient Cancer Center

West Hollywood, California, 90048, United States

Location

Kentuckiana Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Louisiana State University Health Science Center

Kenner, Louisiana, 70065, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of New Mexico Cancer Care Center

Albuquerque, New Mexico, 97239, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Liver Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biocancer - Centro de Pesquisa e Tratamento do Câncer

Belo Horizonte, Brazil

Location

Hospital LifeCenter

Belo Horizonte, Brazil

Location

Oxion Medicina Oncológica

Belo Horizonte, Brazil

Location

Hospital Universitário de Brasilia

Brasília, Brazil

Location

Hospital Erasto Gaertner

Curitiba, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Location

Hospital de Base de São José do Rio Preto

São José do Rio Preto, Brazil

Location

VFN Onkologicka klinika

Prague, 12808, Czechia

Location

Sir Gangaram Hospital

Delhi, India

Location

Indo-American Cancer Institute & Research Centre

Hyderabad, India

Location

Omega Hospitals

Hyderabad, India

Location

Santokaba Durlabhji Memorial Hospital and Research Institute

Jaipur, 302015, India

Location

Bhagwan Mahaveer cancer hospital and research centre

Jaipur, India

Location

Shatabdi Super Speciality hospital

Mumbai, 422005, India

Location

Tata Memorial Hospital

Mumbai, India

Location

Paul Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Klinika Endokrynologii, Diabetologii i Leczenia Izotopami

Wroclaw, 50-367, Poland

Location

Non-Federal Institution of Healthcare "Central Clinical Hospital # 1 of the LLC "Russian Railways (RZD)"

Moscow, Russia

Location

Russian Academy of Medical Sciences "Russian Oncological Research Centre named after N.N. Blokhin RAMS"

Moscow, Russia

Location

Federal Institution of Healthcare "Leningradsky Regional Oncological Dispensary"

Saint Petersburg, Russia

Location

Clinic of Endocrinology, diabetes and metabolic diseases, Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Oncology Institute of Vojvodina, Sremska Kamenica

Kamenitz, 21 204, Serbia

Location

Rondebosch Oncology Unit

Cape Town, 7700, South Africa

Location

Groote Schuur Hospital

Cape Town, South Africa

Location

Westridge Medical Centre

Durban, South Africa

Location

GVI Oncology Clinical Trial Unit

Port Elizabeth, 7570, South Africa

Location

Erciyes University Medical Faculty

Kayseri, 38039, Turkey (Türkiye)

Location

Cherkassy Regional Oncology Dispensary

Cherkassy, Ukraine

Location

Chernivtsi Regional Oncology Center

Chernivtsi, 58013, Ukraine

Location

Oncology and Medical Radiology Chair of Dnepropetrovsk State Medical Academy

Dnipro, Ukraine

Location

Regional Anticancer Center, Department of oncoproctology

Donetsk, Ukraine

Location

Municipal Clinical Hospital #2, Proctology department

Kharkiv, Ukraine

Location

Kyiv City Oncological Hospital, Thoracic department

Kyiv, Ukraine

Location

Medical Centre "Mriya"

Kyiv, Ukraine

Location

National Cancer Institute

Kyiv, Ukraine

Location

Odessa Regional Clinical Hospital

Odesa, 65117, Ukraine

Location

Uzhgorods'ka Tsentral'na Mis'ka Klinichna Likarnya, Mis'kyy Onkologichnyy Tsentr

Uzhhorod, Ukraine

Location

Vinnytsya Regional Clinical Oncological Center, Vinnytsya State Medical University

Vinnytsia, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 27214300 RESULT

• 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.

  PMID: 31754316 DERIVED

MeSH Terms

Conditions

Serotonin Syndrome; Carcinoid Tumor; Neuroendocrine Tumors; Diarrhea; Flushing

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Manifestations

Limitations and Caveats

None specified.

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 17, 2008
• Study Start: May 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2015
• Last Updated: October 14, 2022
• Results First Posted: February 9, 2016

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Locations

RU (3); TU (1); UA (11); LA (1); IN (7); BR (7); US (16); PL (1); CZ (1); SE (2); ZA (4)