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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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

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 Summary:
Sponsor: Ipsen

Current Primary Outcome: Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale [ Time Frame: Week 24 ]

Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)


Original Primary Outcome: The percentage of patients with a positive overall satisfactory relief of symptoms on the Likert scale [ Time Frame: 24 weeks ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes) [ Time Frame: 24 weeks ]
  • Change in the Quality of Life (QoL) Assessment [ Time Frame: 24 weeks ]
  • Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A [ Time Frame: 24 weeks ]
  • Adverse events, including any findings from an examination of the injection site(s). [ Time Frame: At each visit ]
  • Minimum Concentration (Cmin) BIM 23A760 Plasma Levels [ Time Frame: 24 weeks ]
  • Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels [ Time Frame: 24 weeks ]
  • Clinical safety criteria: physical examination, vital signs, weight, 12 lead electrocardiogram (ECG), gallbladder ultrasonography and echocardiography, 24hr blood pressure record [ Time Frame: 24 weeks ]
  • Clinical laboratory safety tests [ Time Frame: 24 weeks ]


Information By: Ipsen

Dates:
Date Received: November 24, 2009
Date Started: February 2010
Date Completion:
Last Updated: August 6, 2015
Last Verified: August 2015