Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
- Registration Number
- NCT01018953
- Lead Sponsor
- Ipsen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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 regurgitation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BIM 23A760 BIM 23A760 This dose adaptive study is planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed are 1, 2, 4, 6 and 8 mg, however, the maximum starting dose will be 4 mg. The starting dose of the first cohort will be 1 mg; the first cohort will include at least five patients. After the first fifteen patients have been treated for 4 weeks, the results will be reviewed by a Data Review Committee. An extension phase (Part B) is planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).
- Primary Outcome Measures
Name Time Method Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale Week 24 Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)
- Secondary Outcome Measures
Name Time Method Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels At 8 timepoints up to week 24 Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes) Up to week 24 Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s) Up to week 26 Change in the Quality of Life (QoL) Assessment Week 24 Minimum Concentration (Cmin) BIM 23A760 Plasma Levels At 9 timepoints up to 1 week after 24th administration in week 24 Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A Week 24
Trial Locations
- Locations (54)
University Hospital, Internal Medicine - Oncology
🇦🇹Vienna, Austria
UZ Antwerpen
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
UZ GAsthuisberg
🇧🇪Leuven, Belgium
Fakultní nemocnice Hradec Králové
🇨🇿Hradec Králové, Czechia
Fakultní nemocnice Olomouc
🇨🇿Olomouc, Czechia
Fakultní nemocnice Na Bulovce, Ústav radiační onkologie
🇨🇿Praha 8, Czechia
Helsinki Central University Hospital
🇫🇮Helsinki, Finland
Turku University Hospital
🇫🇮Turku, Finland
Service de Gastroentérologie
🇫🇷Clichy, France
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