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

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.

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.