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

• Register: EUCTR
• Last refreshed on: 12 June 2012
• Main ID: EUCTR2009-013222-16-NL
• Date of registration: 24/09/2009
• Prospective Registration: Yes
• Primary sponsor: Ipsen Pharma
• Public 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 carcinoid syndrome
• Scientific 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 carcinoid syndrome
• Date of first enrolment: 12/05/2010
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013222-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no Other trial design description: adaptive - The number of patient treated at a starting dose will depend on a data review commitee If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, Belgium, Czech Republic, Finland, France, Germany, Ireland, Italy, Latvia, Netherlands, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. The patient has provided written informed consent prior to any study related procedures.
2. Male or female, between 18 and 75 years inclusive.
3. Females of childbearing potential must provide a negative pregnancy test at the start of the study. Female patients who are at risk of becoming pregnant must agree to use an effective method of contraception such as double barrier contraception, an injectable or implanted hormonal contraceptive, combined oral contraceptive or an intra-uterine device (IUD). The patient must agree to use the contraception for two months after the last investigational medicinal product (IMP) administration. Nonchildbearing potential is defined as being postmenopausal for at least 1 year, or permanently sterilised at least 3 months before study entry.
4. Male patients must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception (see above).
5. The patient has a carcinoid syndrome defined as =3 stools/day and/or =3 flushes/week at study entry (Visit 1). This will be confirmed at Visit 2 by reviewing the information provided in the patient diary card during the screening period.
6. The patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting tumour of unknown localisation with hepatic metastasis (documented biopsy).
7. The patient has elevated 5-HIAA (above the upper limit of normal (ULN)).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. 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.
2. 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.
3. The patient has received a radiolabelled SSA at any time before study entry.
4. The patient has received long acting SSAs as follows:
• More than three injections at any time before study entry
• Between one and three injections, with the last injection
within the period before study entry referenced below.

Lanreotide Lanreotide Lanreotide
Autogel 60mg Autogel 90mg Autogel 120mg
or Octreotide or Octreotide or Octreotide
LAR 10mg LAR 20mg LAR 30MG

1 injection 6 weeks 8 weeks 10 weeks
2 injections 8 weeks 10 weeks 12 weeks
3 injections 10 weeks 12 weeks 14 weeks

5. The patient has a pancreatic tumour or a bronchial tumour.
6. The patient has previously received any specific anti-tumour treatment such as chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months or is anticipated to receive any of these treatments during the study (based on Investigator’s judgement).
7. The patient is lactating or at risk of lactating during the study.
8. The patient has signs or symptoms of cardiac insufficiency.
9. The patient has an ejection fraction <40% and/or clinically severe cardiac valvular regurgitation, centrally assessed during the screening period.
10. The patient has uncontrolled arterial hypertension.
11. The patient has had a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus). Patients with a history of cancer that was not basocellular carcinoma of the skin or in situ carcinoma of the cervix/uterus can be included if they have been treated with curative intent and have been free from disease for more than 5 years.
12. The patient has received BIM 23A760 prior to the study.
13. The patient has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) > 8%).
14. The patient has insulin treated diabetes and has been treated for less than 6 months prior to study entry.
15. The patient has any clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) >3 x ULN and/or alanine aminotransaminase (ALT) >3 x ULN and/or alkaline phosphatase (ALP) >3 x ULN and/or conjugated bilirubin >1.5 x ULN during the screening period.
16. The patient has abnormal findings during the screening period, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient’s safety.
17. The patient has been treated with any other IMP prior to the first study visit without undergoing a washout period of seven times the elimination half-life of the IMP.
18. The patient has a known hypersensitivity to any of the test materials or related compounds.
19. The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol.
20. The patient has a history of, or known current, problems with alcohol or drug abuse.
21. The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an unco-opera

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

carcinoid syndrome
MedDRA version: 12.0 Level: LLT Classification code 10007270 Term: Carcinoid syndrome

Intervention(s)

Product Name: BIM 23A760
Product Code: BIM 23A760
Pharmaceutical Form: Solution for injection
CAS Number: 868562-36-1
Current Sponsor code: BIM 23A760
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Secondary Objective: •To assess the efficacy of repeated s.c. injections at different doses of BIM 23A760 on carcinoid symptoms (diarrhoea and/or flushes)
• To assess the efficacy of BIM 23A760 on quality of life (QoL)
• To assess the efficacy of BIM 23A760 on 5-HIAA and chromogranin A
• To investigate the safety and tolerability of BIM 23A760 administered by repeated s.c. injections at different doses to patients with carcinoid syndrome
• To investigate the PK of BIM 23A760 administered by repeated s.c. injections at different doses to patients with carcinoid syndrome.

Primary end point(s): The percentage of patients with a positive overall satisfactory relief of symptoms on the Likert score after 24 weeks of treatment.

Main Objective: To assess the efficacy of repeated s.c. injections at different doses 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.

Secondary ID(s)

2009-013222-16-SE

8-55-52060-004