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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Carcinoid Syndrome

Thank you

Trial Information

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


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The percentage of patients with a positive overall satisfactory relief of symptoms on the Likert scale

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Catherine Lesage, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Czech Republic: State Institute for Drug Control

Study ID:

8-55-52060-004

NCT ID:

NCT01018953

Start Date:

February 2010

Completion Date:

January 2011

Related Keywords:

  • Carcinoid Syndrome
  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome
  • Serotonin Syndrome

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