Spots Global Cancer Trial Database for An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
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Trial Identification
Brief Title: An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
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 ID: NCT00774930
Conditions
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
VA Greater Los Angeles Health Care System, Los Angeles, California, United States
David Geffen School of Medicine at UCLA, Los Angeles, California, United States
Stanford Cancer Center, Stanford, California, United States
Cedars Sinai Outpatient Cancer Center, West Hollywood, California, United States
Kentuckiana Cancer Institute, Louisville, Kentucky, United States
Louisiana State University Health Science Center, Kenner, Louisiana, United States
University of Michigan, Ann Arbor, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
University of New Mexico Cancer Care Center, Albuquerque, New Mexico, United States
Providence Portland Medical Center, Portland, Oregon, United States
Oregon Health Science University, Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
UPMC Liver Cancer Center, Pittsburgh, Pennsylvania, United States
Eastern Virginia Medical School, Norfolk, Virginia, United States
Froedtert & Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Biocancer - Centro de Pesquisa e Tratamento do Câncer, Belo Horizonte, , Brazil
Hospital LifeCenter, Belo Horizonte, , Brazil
Oxion Medicina Oncológica, Belo Horizonte, , Brazil
Hospital Universitário de Brasilia, Brasilia, , Brazil
Hospital Erasto Gaertner, Curitiba, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, , Brazil
Hospital de Base de São José do Rio Preto, São José do Rio Preto, , Brazil
VFN Onkologicka klinika, Prague, , Czechia
Sir Gangaram Hospital, Delhi, , India
Indo-American Cancer Institute & Research Centre, Hyderabad, , India
Omega Hospitals, Hyderabad, , India
Santokaba Durlabhji Memorial Hospital and Research Institute, Jaipur, , India
Bhagwan Mahaveer cancer hospital and research centre, Jaipur, , India
Shatabdi Super Speciality hospital, Mumbai, , India
Tata Memorial Hospital, Mumbai, , India
Paul Stradins Clinical University Hospital, Riga, , Latvia
Klinika Endokrynologii, Diabetologii i Leczenia Izotopami, Wrocław, , Poland
Non-Federal Institution of Healthcare "Central Clinical Hospital # 1 of the LLC "Russian Railways (RZD)", Moscow, , Russian Federation
Russian Academy of Medical Sciences "Russian Oncological Research Centre named after N.N. Blokhin RAMS", Moscow, , Russian Federation
Federal Institution of Healthcare "Leningradsky Regional Oncological Dispensary", Saint-Petersburg, , Russian Federation
Clinic of Endocrinology, diabetes and metabolic diseases, Clinical Center of Serbia, Belgrade, , Serbia
Oncology Institute of Vojvodina, Sremska Kamenica, Sremska Kamenica, , Serbia
Rondebosch Oncology Unit, Cape Town, , South Africa
Groote Schuur Hospital, Cape Town, , South Africa
Westridge Medical Centre, Durban, , South Africa
GVI Oncology Clinical Trial Unit, Port Elizabeth, , South Africa
Erciyes University Medical Faculty, Kayseri, , Turkey
Cherkassy Regional Oncology Dispensary, Cherkassy, , Ukraine
Chernivtsi Regional Oncology Center, Chernivtsi, , Ukraine
Oncology and Medical Radiology Chair of Dnepropetrovsk State Medical Academy, Dnepropetrovsk, , Ukraine
Regional Anticancer Center, Department of oncoproctology, Donetsk, , Ukraine
Municipal Clinical Hospital #2, Proctology department, Kharkiv, , Ukraine
Kyiv City Oncological Hospital, Thoracic department, Kyiv, , Ukraine
Medical Centre "Mriya", Kyiv, , Ukraine
National Cancer Institute, Kyiv, , Ukraine
Odessa Regional Clinical Hospital, Odessa, , Ukraine
Uzhgorods'ka Tsentral'na Mis'ka Klinichna Likarnya, Mis'kyy Onkologichnyy Tsentr, Uzhgorod, , Ukraine
Vinnytsya Regional Clinical Oncological Center, Vinnytsya State Medical University, Vinnytsya, , Ukraine
Contact Details
Name: Ipsen Medical Director
Affiliation: Ipsen
Role: STUDY_DIRECTOR
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