Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

Phase 2

Terminated

• Conditions: Carcinoid Syndrome
• Interventions: Drug: BIM 23A760

• 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

Study Timeline

• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Study Start: 2010-02
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Results First Submitted: 2015-06-15
• Results First Submitted QC: 2015-08-06
• Results First Posted: 2015-09-07
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

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