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

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Dopamine; Somatostatin

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.