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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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.
Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale
Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)
Time frame: Week 24
Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)
Time frame: Up to week 24
Change in the Quality of Life (QoL) Assessment
Time frame: Week 24
Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A
Time frame: Week 24
Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)
Time frame: Up to week 26
Minimum Concentration (Cmin) BIM 23A760 Plasma Levels
Time frame: At 9 timepoints up to 1 week after 24th administration in week 24
Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels
Time frame: At 8 timepoints up to week 24
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