Acromegaly
Conditions
Interventions
Trade Name: Somatuline Autogel 60mg
Product Name: Somatuline Autogel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lanreotide
Sponsors
Plymouth Hospital NHS Trust, R&D dept
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient must give written (personally signed and dated) informed consent • The patient is over 18 years of age inclusive. • The patient has active acromegaly as diagnosed by oral glucose tolerance test and IGF-1 measurement. Acromegaly must be confirmed prior to study entry based on failure to suppress GH during an oral glucose tolerance test and IGF-1 above the normal range. • The patient has a pituitary adenoma tumour size greater than 5 mm along the longest axis on MRI. • The patient has a life expectancy of at least 2 years. 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: • The patient is considered unfit for surgery. • The patient has a significant visual field defect thought to be due to optic chiasm compression at the time of presentation where the risk of visual loss is considered too great to delay surgery. • The patient has a pituitary adenoma tumour of 5 mm or less along the longest axis, with margins clearly defined within pituitary fossa. • The patient has had any prior pituitary surgery (adenectomy). • The patient has received pituitary radiotherapy within one year prior to screening. • The patient has been previously treated with a GH antagonist or a somatostatin analogue. • The patient has clinically significant renal or hepatic abnormalities. • The patient is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To see whether a twelve month period of primary medical treatment of acromegaly with Somatuline Autogel will produce clinically significant reductions in tumour size from Baseline to Month 12 as assessed using MRI, pre-operatively.; Secondary Objective: • To assess the change in tumour size during the 12 month treatment period. • To assess the change in the GH and IGF-1 during the treatment period. • To assess the change in quality of life scores (SF-36 questionnaire) during the treatment period. • To determine the incidence of new hormonal axes defects arising during the treatment period. • To determine the proportion of patients requiring surgery during the twelve month study period (i.e. those with tumour progression or intolerable symptoms on medical therapy). • To evaluation the safety and tolerability of each dose of Somatuline Autogel. ;Primary end point(s): • The percentage of patients showing a clinically significant change in tumour size at Month 12 compared to baseline as assessed using MRI. | — |
Countries
United Kingdom
Outcome results
None listed