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

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

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoid Syndrome
• Intervention / Treatment: Drug: BIM 23A760

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-9010
    • University Hospital, Internal Medicine - Oncology
• Belgium
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Gasthuisberg
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 775 20
    • Fakultní Nemocnice Olomouc
  • Praha 8, Czechia, 180 81
    • Fakultní nemocnice Na Bulovce, Ústav radiační onkologie
• Finland
  • Helsinki, Finland, FIN-00029
    • Helsinki Central University Hospital
  • Turku, Finland, FIN-20521
    • Turku University Hospital
• France
  • Clichy, France
    • Service de Gastroentérologie
  • Lyon, France, Cedex 03
    • Unité d'Oncologie Médicale
  • Marseille, France, 13009
    • Institut Paoli Calmette
  • Nantes, France, 44805
    • Centre Rene Gauducheau
  • Villejuif, France
    • Unité de Gastro-Entérologie
• Germany
  • Berlin, Germany, 13353
    • Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Mainz, Germany, 55131
    • Universitätsmedizin Mainz
• Ireland
  • Dublin, Ireland
    • St James's Hospital
• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
• Italy
  • Bologna, Italy, 40138
    • Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi
  • Cremona, Italy, 26100
    • Istituti Ospitalieri di Cremona
  • Genova, Italy, 16132
    • Ospedale San Martino
  • Modena, Italy, 41124
    • AO Universitaria Policlinico di Modena
  • Perugia, Italy, 06132
    • Ospedale S.Maria della Misericordia
  • Roma, Italy, 00109
    • Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea
• Latvia
  • Riga, Latvia, LV-1079
    • Latvian Oncology centre of Riga Eastern Clinical University Hospital
  • Valmiera, Latvia, LV-4201
    • Vidzemes Hospital
• Netherlands
  • Groningen, Netherlands, 9700
    • UMCG
  • Rotterdam, Netherlands, 3015
    • Erasmus MC
• Poland
  • Gliwice, Poland, 44-101
    • Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach
  • Krakow, Poland, , 31-501
    • Szpital Uniwersytecki W Krakowie
  • Warszawa, Poland, 02-785
    • Instytut im Marii Sklodowskiej Curie
  • Wroclaw, 50-367, Poland, 50-367
    • Samodzielny Publiczny Szpital Kliniczny nr 1
• Russian Federation
  • Barnaul, Russian Federation, 656052
    • Altay Regional Oncology Dispensary
  • Kazan, Russian Federation, 420111
    • Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan
  • Moscow, Russian Federation, 125367
    • Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"
  • Saint Petersburg, Russian Federation, 197089
    • St-Petersburg State Medical University named after academician Pavlov I.P.
  • Saint Petersburg, Russian Federation, 198255
    • St-Petersburg State Institution of Public Health City Clinical Oncology dispensary
  • Tula, Russian Federation, 300053
    • Tula Regional Oncology Dispensary
  • Voronezh, Russian Federation, 394000
    • Voronezh Regional Clinical Oncology Dispensary
• Slovakia
  • Bratislava, Slovakia, 83310
    • Národný onkologický ústav
  • Martin, Slovakia, 03601
    • Martinska fakultna nemocnice
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Palma de Mallorca, Spain, 07014
    • Hospital Universitario Son Dureta
• Sweden
  • Uppsala, Sweden, 751 85
    • Akademiska Hospital, Dept of Oncology & Endocrinology
• Ukraine
  • Donetsk, Ukraine, 83092
    • Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center
  • Uzhgorod, Ukraine, 88000
    • Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital
• United Kingdom
  • Liverpool, United Kingdom, L9 7AL
    • University Hospital Aintree
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew'S Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital and Holt Radium Institute
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital, Sharoe Green Lane, Lancashire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)	Up to week 24
Change in the Quality of Life (QoL) Assessment	Week 24
Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A	Week 24
Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)	Up to week 26
Minimum Concentration (Cmin) BIM 23A760 Plasma Levels	At 9 timepoints up to 1 week after 24th administration in week 24
Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels	At 8 timepoints up to week 24

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: November 24, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Disease; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Drug-Related Side Effects and Adverse Reactions; Syndrome; Carcinoid Tumor; Malignant Carcinoid Syndrome; Serotonin Syndrome
• Other Study ID Numbers: 8-55-52060-004; 2009-013222-16 (EudraCT Number)