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

Primary Purpose

Carcinoid Syndrome

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIM 23A760
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoid Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

BIM 23A760

Arm Description

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)
Change in the Quality of Life (QoL) Assessment
Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A
Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)
Minimum Concentration (Cmin) BIM 23A760 Plasma Levels
Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels

Full Information

First Posted
November 24, 2009
Last Updated
November 4, 2020
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT01018953
Brief Title
Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Preliminary data from study NCT00994214 do not support expected inhibition of GH and IGF-1
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital, Internal Medicine - Oncology
City
Vienna
ZIP/Postal Code
A-9010
Country
Austria
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ GAsthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Fakultní nemocnice Hradec Králové
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultní nemocnice Na Bulovce, Ústav radiační onkologie
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Helsinki Central University Hospital
City
Helsinki
ZIP/Postal Code
FIN-00029
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
FIN-20521
Country
Finland
Facility Name
Service de Gastroentérologie
City
Clichy
Country
France
Facility Name
Unité d'Oncologie Médicale
City
Lyon
ZIP/Postal Code
Cedex 03
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Unité de Gastro-Entérologie
City
Villejuif
Country
France
Facility Name
Charite Universitätsmedizin Berlin, Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsmedizin Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
St James's Hospital
City
Dublin
Country
Ireland
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Università degli Studi di Bologna, Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituti Ospitalieri di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
AO Universitaria Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Ospedale S.Maria della Misericordia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Università degli Studi di Roma "La Sapienza", II Facoltà di Medicina e Chirurgia, Ospedale Sant'Andrea
City
Roma
ZIP/Postal Code
00109
Country
Italy
Facility Name
Latvian Oncology centre of Riga Eastern Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Vidzemes Hospital
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9700
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie oddzial w Gliwicach
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
, 31-501
Country
Poland
Facility Name
Instytut im Marii Sklodowskiej Curie
City
Warszawa
ZIP/Postal Code
02-785
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1
City
Wroclaw, 50-367
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Altay Regional Oncology dispensary
City
Barnaul
ZIP/Postal Code
656052
Country
Russian Federation
Facility Name
Republican Clinical Oncology dispensary of the Ministry of Health of Republic of Tatarstan
City
Kazan
ZIP/Postal Code
420111
Country
Russian Federation
Facility Name
Non-state Institution of Public health "Central Clinical hospital # 1, public corporation "Russian railways"
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
St-Petersburg State Medical University named after academician Pavlov I.P.
City
Saint Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
St-Petersburg State Institution of Public Health City Clinical Oncology dispensary
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Tula Regional Oncology Dispensary
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Oncology Dispensary
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
Martinska fakultna nemocnice
City
Martin
ZIP/Postal Code
03601
Country
Slovakia
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Son Dureta
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Akademiska Hospital, Dept of Oncology & Endocrinology
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Donetsk National Medical University named after M. Gorkiy, Donetsk Regional Antitumor Center
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Uzhgorod national university, Postgraduate faculty, Uzhgorod Central City Clinical Hospital
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
University Hospital Aintree
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Christie Hospital and Holt Radium Institute
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Preston Hospital, Sharoe Green Lane, Lancashire
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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