To Assess Efficacy & Safety of BIM23A760 in patients with Acromegaly

• Research type

  Research Study

• Full 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

• IRAS ID

  27028

• Eudract number

  2009-010787-42

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Acromegaly is a rare disease. Its prevalence is about 50 to 70 cases per million but recent data suggest that it could be more than 100 per million. Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH). The disease spreads harmfully in a subtle manner, causing a gradual progression of symptoms, and diagnosis can be delayed up to 10 years, therefore most patients are diagnosed in their fourth decade of life. Management of acromegaly includes surgery, radiotherapy and medical treatments.Surgery is almost always the first line therapy with success rates above 50% and up to 90% for those with microadenomas (a less than 1 cm pituitary adenoma) operated. Currently available medical options include dopamine agonists (DA), somatostatin (SST) analogues, and a growth hormone receptor antagonist (GHRA). Current treatments do not achieve the control of the tumour in all patients or the treatment is not very convenient and does not target the tumour. Therefore there is a clear unmet medical need for efficacy in a broader spectrum of patients with acromegaly. The purpose of this study is to evaluate the efficacy and the safety of BIM 23A760 after repeated subcutaneous administration (i.e. injection of the study drug under the skin) given every week in different doses.To be eligible to take part in this trial amongst other factors patients must be over the age of 18. It is estimated that approximately 60 patients will be enrolled and patients are expected to participate for approximately 30 weeks. The study consists of a 30 day screening period, followed by a 24 week treatment period, during which patients will receive weekly injections of BIM 23A760. Assessments will be performed at each visit. Each patient will have 10 study visits.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/94

• Date of REC Opinion

  9 Oct 2009

• REC opinion

  Further Information Favourable Opinion