Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
NCT ID: NCT01018953
Last Updated: 2020-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2010-02-28
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BIM 23A760
This dose adaptive study is planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed are 1, 2, 4, 6 and 8 mg, however, the maximum starting dose will be 4 mg. The starting dose of the first cohort will be 1 mg; the first cohort will include at least five patients. After the first fifteen patients have been treated for 4 weeks, the results will be reviewed by a Data Review Committee. An extension phase (Part B) is planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
BIM 23A760
BIM 23A760 is a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 dose of 1, 2, 4, 6 and 8 mg can be given to the patient according to a dose escalation and titration process. Patients will receive 24 weekly injections of BIM 23A760 during the treatment period. Patients eligible to continue the extension phase will be administered BIM 23A760 for further 52 weekly injections.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIM 23A760
BIM 23A760 is a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 dose of 1, 2, 4, 6 and 8 mg can be given to the patient according to a dose escalation and titration process. Patients will receive 24 weekly injections of BIM 23A760 during the treatment period. Patients eligible to continue the extension phase will be administered BIM 23A760 for further 52 weekly injections.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The patient has elevated 5-Hydroxyindoleacetic acid (above upper limit normal).
* The patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting tumour of unknown localisation with hepatic metastasis.
Exclusion Criteria
* The patient has received short acting somatostatin analogues (SSAs) within 2 weeks before study entry or has received short acting SSAs for more than 3 months.
* The patient has received a radiolabelled SSA at any time before study entry.
* The patient has received long acting SSAs under certain circumstances.
* The patient has previously received any specific anti tumour treatment such as chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months.
* The patient has signs or symptoms of cardiac insufficiency.
* The patient has an ejection fraction \<40% and/or clinically severe cardiac valvular regurgitation.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ipsen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital, Internal Medicine - Oncology
Vienna, , Austria
UZ Antwerpen
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
UZ GAsthuisberg
Leuven, , Belgium
Fakultní nemocnice Hradec Králové
Hradec Králové, , Czechia
Fakultní nemocnice Olomouc
Olomouc, , Czechia
Fakultní nemocnice Na Bulovce, Ústav radiační onkologie
Prague, , Czechia
Helsinki Central University Hospital
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Service de Gastroentérologie
Clichy, , France
Unité d'Oncologie Médicale
Lyon, , France
Institut Paoli Calmette
Marseille, , France
Centre René Gauducheau
Nantes, , France
Unité de Gastro-Entérologie
Villejuif, , France
Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
Berlin, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsmedizin Mainz
Mainz, , Germany
St James's Hospital
Dublin, , Ireland
Hadassah Medical Organization
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi
Bologna, , Italy
Istituti Ospitalieri di Cremona
Cremona, , Italy
Ospedale San Martino
Genova, , Italy
AO Universitaria Policlinico di Modena
Modena, , Italy
Ospedale S.Maria della Misericordia
Perugia, , Italy
Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea
Roma, , Italy
Latvian Oncology centre of Riga Eastern Clinical University Hospital
Riga, , Latvia
Vidzemes Hospital
Valmiera, , Latvia
UMCG
Groningen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach
Gliwice, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Instytut im Marii Sklodowskiej Curie
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Wroclaw, 50-367, , Poland
Altay Regional Oncology dispensary
Barnaul, , Russia
Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan
Kazan', , Russia
Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"
Moscow, , Russia
St-Petersburg State Medical University named after academician Pavlov I.P.
Saint Petersburg, , Russia
St-Petersburg State Institution of Public Health City Clinical Oncology dispensary
Saint Petersburg, , Russia
Tula Regional Oncology Dispensary
Tula, , Russia
Voronezh Regional Clinical Oncology Dispensary
Voronezh, , Russia
Narodny onkologicky ustav
Bratislava, , Slovakia
Martinska fakultna nemocnice
Martin, , Slovakia
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario Son Dureta
Palma de Mallorca, , Spain
Akademiska Hospital, Dept of Oncology & Endocrinology
Uppsala, , Sweden
Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center
Donetsk, , Ukraine
Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital
Uzhhorod, , Ukraine
University Hospital Aintree
Liverpool, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Christie Hospital and Holt Radium Institute
Manchester, , United Kingdom
Royal Preston Hospital, Sharoe Green Lane, Lancashire
Preston, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-013222-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8-55-52060-004
Identifier Type: -
Identifier Source: org_study_id