Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome (CAMPANULA)

Ipsen

Status and phase: Terminated; Phase 2

Conditions: Carcinoid Syndrome

Treatments: Drug: BIM 23A760

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018953

2009-013222-16 (EudraCT Number)

8-55-52060-004

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

BIM 23A760

Experimental group

Description:

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).

Treatment:

Drug: BIM 23A760