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)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01018953
First received: November 24, 2009
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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:
  • The percentage of patients with a positive overall satisfactory relief of symptoms on the Likert scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with improvement in symptoms (diarrhoea and/or flushes) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in the Quality of Life (QoL) assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in 5 hydroxyindoleacetic acid (5 HIAA) and chromogranin A [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events, including any findings from an examination of the injection site(s). [ Time Frame: At each visit ] [ Designated as safety issue: Yes ]
  • Minimum concentration (Cmin) BIM 23A760 plasma levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Concentration at 2 hours postdose (C2 hours) BIM 23A760 plasma levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical safety criteria: physical examination, vital signs, weight, 12 lead electrocardiogram (ECG), gallbladder ultrasonography and echocardiography, 24hr blood pressure record [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical laboratory safety tests [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01018953

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

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01018953     History of Changes
Other Study ID Numbers: 8-55-52060-004
Study First Received: November 24, 2009
Last Updated: October 20, 2011
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:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Syndrome
Carcinoid Tumor
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Dopamine
Somatostatin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014