Clinical trial NCT01018953: Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
Official title: Phase II, Open, Adaptive, Dose Escalating, Multicentre Titration Study to Assess the Efficacy and Safety of Repeated Subcutaneous Administration of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoid Syndrome
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)
timeFrame: Up to week 24
measure: Change in the Quality of Life (QoL) Assessment
timeFrame: Week 24
measure: Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A
timeFrame: Week 24
measure: Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)
timeFrame: Up to week 26
measure: Minimum Concentration (Cmin) BIM 23A760 Plasma Levels
timeFrame: At 9 timepoints up to 1 week after 24th administration in week 24
measure: Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels
timeFrame: At 8 timepoints up to week 24
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Hospital, Internal Medicine - Oncology
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ GAsthuisberg
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Praha 8
country: Czechia
facility: Fakultní nemocnice Na Bulovce, Ústav radiační onkologie
city: Helsinki
country: Finland
facility: Helsinki Central University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Clichy
country: France
facility: Service de Gastroentérologie
city: Lyon
country: France
facility: Unité d'Oncologie Médicale
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Nantes
country: France
facility: Centre René Gauducheau
city: Villejuif
country: France
facility: Unité de Gastro-Entérologie
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Dublin
country: Ireland
facility: St James's Hospital
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Bologna
country: Italy
facility: Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi
city: Cremona
country: Italy
facility: Istituti Ospitalieri di Cremona
city: Genova
country: Italy
facility: Ospedale San Martino
city: Modena
country: Italy
facility: AO Universitaria Policlinico di Modena
city: Perugia
country: Italy
facility: Ospedale S.Maria della Misericordia
city: Roma
country: Italy
facility: Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea
city: Riga
country: Latvia
facility: Latvian Oncology centre of Riga Eastern Clinical University Hospital
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
city: Groningen
country: Netherlands
facility: UMCG
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Warszawa
country: Poland
facility: Instytut im Marii Sklodowskiej Curie
city: Wroclaw, 50-367
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1
city: Barnaul
country: Russian Federation
facility: Altay Regional Oncology dispensary
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan
city: Moscow
country: Russian Federation
facility: Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"
city: Saint Petersburg
country: Russian Federation
facility: St-Petersburg State Medical University named after academician Pavlov I.P.
city: Saint Petersburg
country: Russian Federation
facility: St-Petersburg State Institution of Public Health City Clinical Oncology dispensary
city: Tula
country: Russian Federation
facility: Tula Regional Oncology Dispensary
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Oncology Dispensary
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Martin
country: Slovakia
facility: Martinska fakultna nemocnice
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
city: Uppsala
country: Sweden
facility: Akademiska Hospital, Dept of Oncology & Endocrinology
city: Donetsk
country: Ukraine
facility: Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center
city: Uzhgorod
country: Ukraine
facility: Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital and Holt Radium Institute
city: Preston
country: United Kingdom
facility: Royal Preston Hospital, Sharoe Green Lane, Lancashire
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: