A phase III study of pasireotide in patients with acromegaly Version 1
Research type
Research Study
Full title
A phase III, multicenter, randomised, parallel-group study to assess the efficacy and safety of double-blind pasireotide LAR 40 mg and pasireotide LAR 60 mg versus open-label octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly
IRAS ID
100717
Contact name
Karla Martins
Sponsor organisation
Novartis Pharma AG
Eudract number
2009-016722-13
Clinicaltrials.gov Identifier
Research summary
Acromegaly is a rare condition caused, in almost all cases by the prolonged excess release of growth hormone from the pituitary gland. Some of the cells in the pituitary gland, which normally produce growth hormone, start to divide more rapidly than normal. The continued growth of these hormone producing cells results in a pituitary 'adenoma' or tumour. The tumour is almost always benign (not cancerous) and does not spread to other parts of the body. The disease is characterized by symptoms caused by excess growth hormone (GH) and insulin-like growth factor 1 (IGF-1) which mediates the effects of GH. Life expectancy is reduced mostly due to an increased risk for cardiovascular disease. In addition, the tumour mass can lead to headaches, visual field defects and blindness. The therapeutic goal is to decrease the morbidity and mortality of patients with acromegaly to the expected age- and sex- adjusted rates by removing the tumour mass or controlling its growth and to restore GH secretion and action to normal. The currently available treatments include surgery, radiotherapy or drug treatment. Somatostatin analogues octreotide and lanreotide have a good safety profile, are well-tolerated and effective. Growth hormone antagonists and dopamine agonists are also used. Pasireotide is a novel cyclohexapeptide somatostatin analogue that compared with the approved somatostatin analogues, has a greater binding affinity i.e. binds to more tumour receptors. This may result in improved efficacy. Two studies have evaluated pasireotide (CSOM230B2201 and CSOM230C2110) and have shown that it has a good safety profile, is effective and well-tolerated. This study will evaluate the safety and efficacy of pasireotide LAR 40mg and pasireotide LAR 60mg in patients with inadequately controlled acromegaly by either octreotide LAR or lanreotide ATG at maximum indicated doses. 186 patients will be enrolled into the core study. The duration of their participation in the core study is 28 weeks with total treatment duration being 24 weeks. The core study has an open-label, active control arm and is blinded for the dose of the pasireotide LAR treatment arms. There will be 10 visits in the core study and procedures include physical examination, vital signs, height and body weight, ECG, MRI scan, Gallbladder ultrasound, pregnancy test (for females), blood and urine tests, tumour samples and quality of life questionnaires. The extension study will collect additional efficacy and safety data and will offer all patients who have been assigned to the open-label control arm in the core study and not achieved biochemical control, the possibility to start treatment with pasireotide LAR 40mg.Approximately 160 patients will be enrolled into the extension study. Patients can continue in this extension study as long as they remain eligible or until pasireotide LAR is commercially available for the treatment of acromegaly or the entire pasireotide program is discontinues (whichever comes first). Novartis is the sponsor of this clinical trial.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
12/SC/0129
Date of REC Opinion
26 Apr 2012
REC opinion
Further Information Favourable Opinion