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BIM 23A760 in Carcinoid Syndrome

NCT01018953Phase 2

Key facts

Status: Terminated
Start: Feb 2010
Primary completion: Dec 2010
Countries: 18
Sponsor: Ipsen

Drugs: onzigolide
Conditions: Carcinoid Syndrome (CS)

Overview

Phase 2, open-label, single-arm trial of onzigolide in Carcinoid Syndrome (CS), sponsored by Ipsen. Primary endpoint: Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale at 24 weeks. Started Feb 2010; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

BIM 23A760
Dose adaptive titration arm evaluating multiple dose levels.

Who it enrols

Patients with carcinoid syndrome (diarrhea/flushes) and elevated 5-HIAA with well-differentiated mid-gut or serotonin-secreting tumors and hepatic metastasis.

Endpoints

Primary

Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale24 weeks

Secondary

Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)24 weeks
Change in the Quality of Life Assessment24 weeks
Change in 5 Hydroxyindoleacetic Acid24 weeks
Change in Chromogranin A24 weeks
Number of Subjects Reported Adverse Events26 weeks
Minimum Concentration BIM 23A760 Plasma Levels24 weeks
Concentration at 2 Hours Postdose BIM 23A760 Plasma Levels24 weeks

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