Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
- Registration Number
- NCT01018953
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- The patient has a carcinoid syndrome defined as ≥3 stools/day and/or ≥3 flushes/week.
- 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.
- The patient has undergone surgery related to a neuroendocrine tumour (NET) within 4 weeks prior to study entry or has surgery planned during the study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BIM 23A760 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).
- Primary Outcome Measures
Name Time Method Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale Week 24 Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)
- Secondary Outcome Measures
Name Time Method Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A Week 24 Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels At 8 timepoints up to week 24 Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes) Up to week 24 Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) Up to week 26 Change in the Quality of Life (QoL) Assessment Week 24 Minimum Concentration (Cmin) BIM 23A760 Plasma Levels At 9 timepoints up to 1 week after 24th administration in week 24
Trial Locations
- Locations (54)
University Hospital, Internal Medicine - Oncology
🇦🇹Vienna, Austria
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Altay Regional Oncology dispensary
🇷🇺Barnaul, Russian Federation
Tula Regional Oncology Dispensary
🇷🇺Tula, Russian Federation
Voronezh Regional Clinical Oncology Dispensary
🇷🇺Voronezh, Russian Federation
Martinska fakultna nemocnice
🇸🇰Martin, Slovakia
Unité d'Oncologie Médicale
🇫🇷Lyon, France
UZ Antwerpen
🇧🇪Edegem, Belgium
UZ GAsthuisberg
🇧🇪Leuven, Belgium
UZ Gent
🇧🇪Gent, Belgium
Fakultní nemocnice Na Bulovce, Ústav radiační onkologie
🇨🇿Praha 8, Czechia
Helsinki Central University Hospital
🇫🇮Helsinki, Finland
Fakultní nemocnice Olomouc
🇨🇿Olomouc, Czechia
Turku University Hospital
🇫🇮Turku, Finland
Service de Gastroentérologie
🇫🇷Clichy, France
Institut Paoli Calmette
🇫🇷Marseille, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Centre René Gauducheau
🇫🇷Nantes, France
Universitätsmedizin Mainz
🇩🇪Mainz, Germany
St James's Hospital
🇮🇪Dublin, Ireland
Unité de Gastro-Entérologie
🇫🇷Villejuif, France
Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Hadassah Medical Organization
🇮🇱Jerusalem, 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
Latvian Oncology centre of Riga Eastern Clinical University Hospital
🇱🇻Riga, Latvia
Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea
🇮🇹Roma, Italy
UMCG
🇳🇱Groningen, Netherlands
Vidzemes Hospital
🇱🇻Valmiera, Latvia
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
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
🇵🇱Wroclaw, 50-367, Poland
Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan
🇷🇺Kazan, Russian Federation
Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"
🇷🇺Moscow, Russian Federation
St-Petersburg State Medical University named after academician Pavlov I.P.
🇷🇺Saint Petersburg, Russian Federation
St-Petersburg State Institution of Public Health City Clinical Oncology dispensary
🇷🇺Saint Petersburg, Russian Federation
Narodny onkologicky ustav
🇸🇰Bratislava, 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
🇺🇦Uzhgorod, 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
Fakultní nemocnice Hradec Králové
🇨🇿Hradec Králové, Czechia