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

This study has been terminated.
(Preliminary data from study NCT00994214 do not support expected inhibition of GH and IGF-1)
Information provided by (Responsible Party):
Ipsen Identifier:
First received: November 24, 2009
Last updated: August 6, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Carcinoid Syndrome
Drug: BIM 23A760
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
  • Change in the Quality of Life (QoL) Assessment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) [ Time Frame: Up to week 26 ] [ Designated as safety issue: Yes ]
  • Minimum Concentration (Cmin) BIM 23A760 Plasma Levels [ Time Frame: At 9 timepoints up to 1 week after 24th administration in week 24 ] [ Designated as safety issue: No ]
  • Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels [ Time Frame: At 8 timepoints up to week 24 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01018953

  Show 54 Study Locations
Sponsors and Collaborators
Study Director: Catherine Lesage, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen Identifier: NCT01018953     History of Changes
Other Study ID Numbers: 8-55-52060-004
Study First Received: November 24, 2009
Results First Received: June 15, 2015
Last Updated: August 6, 2015
Health Authority: Czech Republic: State Institute for Drug Control
Ireland: Irish Medicines Board
Israel: Ministry of Health
Latvia: State Agency of Medicines
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: State Pharmacological Center - Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Ministry of Social Affairs and Health
Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Pharmaceutical Agency (AIFA)
Poland: Central Register of Clinical Trials
Sweden: Medical Products Agency
Russia: Federal Service of Supervision in the Sphere of Public Health and Social Development
Slovakia: Statny Ustav pre Kontrolu Lieciv (SUKL)

Additional relevant MeSH terms:
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Pathologic Processes
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Dopamine Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 27, 2015