Pasireotide (SOM230) in patients with acromegaly
Research type
Research Study
Full title
A phase IIIb multicenter, open-label, single arm study to evaluate the efficacy and safety of pasireotide in patients with acromegaly inadequately controlled with first generation somatostatin analogues.
IRAS ID
166088
Contact name
Scott Akker
Contact email
Sponsor organisation
Novartis Pharmaceutical UK Limited
Eudract number
2014-002630-31
Duration of Study in the UK
3 years, 3 months, 21 days
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 (IGF1) 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 in patients with inadequately controlled acromegaly after a minimum of 3 months with high doses of first generation somandostatin analogues. This study will provide further data of efficacy and safety but not confirmation of efficacy, which has been demonstrated in another study, CSOM230C2402. The objective of this new study was chosen based on new published criteria for diagnosis and management of acromegaly relating to optimal disease control.
112 patients will be enrolled into the study. There will be 2 groups of patients:
- Group 1: Patients treated with octreotide LAR 30mg
- Group 2: Patients treated with octreotide LAR 40mg or Lanreotide ATG 120mg
All patients in Group 1 will receive octreotide LAR 40mg treatment every 4 weeks for 16 weeks as a “run-in” period.
All patients will enter the core phase to receive SOM230 (paseriotide) treatment every 4 weeks for up to 32 weeks and if patients are benefitting from treatment, they may enter the extension phase for an additional 32 weeks of treatment.
There will be 12 visits in the core phase and 9 visits in the extension phase, followed by an end of phase visit and a safety follow-up 8 weeks after the last injection. Procedures include physical examination, vital signs, height and body weight, ECG, Gallbladder ultrasound, pregnancy test (for females), blood and urine tests and quality of life questionnaires.
If patients continue to benefit at the end of the extension phase, patients may take part in a separate roll-over study to continue treatment.
Novartis is the sponsor of this clinical trial.REC name
London - Fulham Research Ethics Committee
REC reference
15/LO/0788
Date of REC Opinion
17 Jul 2015
REC opinion
Further Information Favourable Opinion