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

Carcinoid Syndrome Clinical Trial

— CAMPANULA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01018953
• Other study ID #: 8-55-52060-004
• Secondary ID: 2009-013222-16
• Status: Terminated
• Phase: Phase 2
• Start date: February 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Carcinoid Tumor
• Malignant Carcinoid Syndrome
• Serotonin Syndrome
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Austria	University Hospital, Internal Medicine - Oncology	Vienna
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Gent	Gent
Belgium	UZ GAsthuisberg	Leuven
Czechia	Fakultní nemocnice Hradec Králové	Hradec Králové
Czechia	Fakultní nemocnice Olomouc	Olomouc
Czechia	Fakultní nemocnice Na Bulovce, Ústav radiacní onkologie	Praha 8
Finland	Helsinki Central University Hospital	Helsinki
Finland	Turku University Hospital	Turku
France	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
Germany	Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum	Berlin
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsmedizin Mainz	Mainz
Ireland	St James's Hospital	Dublin
Israel	Hadassah Medical Organization	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Italy	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
Latvia	Latvian Oncology centre of Riga Eastern Clinical University Hospital	Riga
Latvia	Vidzemes Hospital	Valmiera
Netherlands	UMCG	Groningen
Netherlands	Erasmus MC	Rotterdam
Poland	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
Russian Federation	Altay Regional Oncology dispensary	Barnaul
Russian Federation	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 Institution of Public Health City Clinical Oncology dispensary	Saint Petersburg
Russian Federation	St-Petersburg State Medical University named after academician Pavlov I.P.	Saint Petersburg
Russian Federation	Tula Regional Oncology Dispensary	Tula
Russian Federation	Voronezh Regional Clinical Oncology Dispensary	Voronezh
Slovakia	Narodny onkologicky ustav	Bratislava
Slovakia	Martinska fakultna nemocnice	Martin
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Son Dureta	Palma de Mallorca
Sweden	Akademiska Hospital, Dept of Oncology & Endocrinology	Uppsala
Ukraine	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
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	Royal Free Hospital	London
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Christie Hospital and Holt Radium Institute	Manchester
United Kingdom	Royal Preston Hospital, Sharoe Green Lane, Lancashire	Preston

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Finland,  France,  Germany,  Ireland,  Israel,  Italy,  Latvia,  Netherlands,  Poland,  Russian Federation,  Slovakia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale	Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)	Week 24
Secondary	Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)		Up to week 24
Secondary	Change in the Quality of Life (QoL) Assessment		Week 24
Secondary	Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A		Week 24
Secondary	Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)		Up to week 26
Secondary	Minimum Concentration (Cmin) BIM 23A760 Plasma Levels		At 9 timepoints up to 1 week after 24th administration in week 24
Secondary	Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels		At 8 timepoints up to week 24