Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome (CAMPANULA)
Carcinoid Syndrome
About this trial
This is an interventional treatment trial for Carcinoid Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University Hospital, Internal Medicine - Oncology
- UZ Antwerpen
- UZ Gent
- UZ GAsthuisberg
- Fakultní nemocnice Hradec Králové
- Fakultní nemocnice Olomouc
- Fakultní nemocnice Na Bulovce, Ústav radiační onkologie
- Helsinki Central University Hospital
- Turku University Hospital
- Service de Gastroentérologie
- Unité d'Oncologie Médicale
- Institut Paoli Calmette
- Centre René Gauducheau
- Unité de Gastro-Entérologie
- Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
- Universitätsklinikum Heidelberg
- Universitätsmedizin Mainz
- St James's Hospital
- Hadassah Medical Organization
- Rabin Medical Center
- Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi
- Istituti Ospitalieri di Cremona
- Ospedale San Martino
- AO Universitaria Policlinico di Modena
- Ospedale S.Maria della Misericordia
- Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea
- Latvian Oncology centre of Riga Eastern Clinical University Hospital
- Vidzemes Hospital
- UMCG
- Erasmus MC
- Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach
- Szpital Uniwersytecki w Krakowie
- Instytut im Marii Sklodowskiej Curie
- Samodzielny Publiczny Szpital Kliniczny nr 1
- Altay Regional Oncology dispensary
- Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan
- Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"
- St-Petersburg State Medical University named after academician Pavlov I.P.
- St-Petersburg State Institution of Public Health City Clinical Oncology dispensary
- Tula Regional Oncology Dispensary
- Voronezh Regional Clinical Oncology Dispensary
- Narodny onkologicky ustav
- Martinska fakultna nemocnice
- Hospital Universitario Ramon y Cajal
- Hospital 12 de Octubre
- Hospital Universitario Son Dureta
- Akademiska Hospital, Dept of Oncology & Endocrinology
- Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center
- Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital
- University Hospital Aintree
- St Bartholomew's Hospital
- Royal Free Hospital
- Christie Hospital and Holt Radium Institute
- Royal Preston Hospital, Sharoe Green Lane, Lancashire
Arms of the Study
Arm 1
Experimental
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).