PHASE II, OPEN, RANDOMISED, PARALLEL GROUP, NONCOMPARATIVE MULTICENTRE STUDY TO ASSESS THE EFFICACY AND SAFETY OF REPEATED SUBCUTANEOUS (S.C.) ADMINISTRATION OF DIFFERENT DOSES OF BIM 23A760 IN ACROMEGALIC PATIENTS

• Register: EUCTR
• Last refreshed on: 12 June 2012
• Main ID: EUCTR2009-010787-42-NL
• Date of registration: 09/07/2009
• Prospective Registration: Yes
• Primary sponsor: Ipsen Pharma
• Public title: PHASE II, OPEN, RANDOMISED, PARALLEL GROUP, NONCOMPARATIVE MULTICENTRE STUDY TO ASSESS THE EFFICACY AND SAFETY OF REPEATED SUBCUTANEOUS (S.C.) ADMINISTRATION OF DIFFERENT DOSES OF BIM 23A760 IN ACROMEGALIC PATIENTS
• Scientific title: PHASE II, OPEN, RANDOMISED, PARALLEL GROUP, NONCOMPARATIVE MULTICENTRE STUDY TO ASSESS THE EFFICACY AND SAFETY OF REPEATED SUBCUTANEOUS (S.C.) ADMINISTRATION OF DIFFERENT DOSES OF BIM 23A760 IN ACROMEGALIC PATIENTS
• Date of first enrolment: 03/03/2010
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010787-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium, Czech Republic, France, Germany, Italy, Latvia, Lithuania, Netherlands, Poland, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion Criteria
All patients must fulfil the following:
1.The patient has provided written informed consent prior to any study related procedures.
2.The patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.
3.Male or female, between 18 and 75 years of age inclusive.
4.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.
5.Male patients must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception (see above).
6.The patient must have a serum level for IGF-1 =1.3 x ULN during the screening period (central laboratory results).
7.Nondiabetic patients must have a Nadir serum GH concentration =0.4 ng/mL in an oral glucose tolerance test (OGTT) during the screening period (central laboratory results).
8.If the patient is receiving replacement therapy (thyroid hormone, corticosteroid or sex hormone) the dose has been stable for at least one month prior to study entry.
9.If the patient is receiving treatment for hypertension, the dose has been stable for at least one month prior to study entry.

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:
Exclusion Criteria
Patients who have undergone pituitary surgery prior to study entry will be excluded if:
1.The time between pituitary surgery and study entry is less than 6 weeks.
2.After surgery, the patient has been treated with somatostatin (SST) analogues (except a single dose of immediate release formulation (IRF) octreotide for testing purposes performed at least 1 month before study entry), dopamine agonists (DAs) or GH receptor antagonists (GHRAs).
3.Before surgery, the patient has received >3 months’ treatment with SST analogues, DAs or GHRAs.
Patients who have not undergone pituitary surgery prior to study entry will be excluded from the study if:
4.The patient has received >3 months’ treatment with SST analogues, DAs or GHRAs.
5.The patient has received short acting SST analogues, DAs or GHRAs within 1 month of study entry.
In addition, patients will not be included in the study if:
6.The patient has received long acting SST analogues within 6 months of study entry.
7.The patient has undergone radiotherapy at any time prior to study entry.
8.It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study.
9.The patient has received BIM 23A760 prior to the study.
10.The patient has uncontrolled diabetes (glycosylated haemoglobin (HbA1c)>8%).
11.The patient has insulin treated diabetes and has been treated for less than 6 months prior to study entry.
12.The patient suffers from macroadenoma with visual field defects due to chiasmatic compression.
13.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.
14.The patient suffers from clinically severe cardiac valvular regurgitation, centrally assessed during the screening period.
15.The patient has any clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 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 7 times the elimination half life of the IMP.
18.The patient has a known hypersensitivity to any of the test materials or related compounds and/or any known contraindications to magnetic resonance imaging (MRI).
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 operative attitude.
22.Female patients are lactating or at risk of lactation during the study.



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

Health Condition(s) or Problem(s) studied

Acromegaly
MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly

Intervention(s)

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)

Main Objective: To assess the efficacy of repeated s.c. injections at different doses of BIM 23A760 on growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels in acromegalic patients after 6 months of treatment.

Primary end point(s): Proportion of patients with mean GH=2.5 ng/mL and normalised IGF-1 at 6 months.

Secondary Objective: •To assess the efficacy of repeated s.c. injection at different doses of BIM 23A760 on GH and IGF-1 levels in acromegalic patients after 3 months of treatment
•To assess the efficacy on finger circumference (ring size) of repeated s.c. injection at different doses of BIM 23A760
•To investigate the safety and tolerability of BIM 23A760 administered by repeated s.c. injection at different doses to acromegalic patients
•To investigate the pharmacokinetics of BIM 23A760 administered by repeated s.c. injection at different doses to acromegalic patients.

Secondary ID(s)

2-55-52060-003

2009-010787-42-SE