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 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.
- 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