NCT01018953

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoid Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2009-11-25
• Last updated: 2020-11-20
• Results posted: 2015-09-07

Locations

54 sites across 18 countries: Austria, Belgium, Czechia, Finland, France, Germany, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Russia, Slovakia, Spain, Sweden, Ukraine, United Kingdom