acromegaly
Conditions
Interventions
Trade Name: pegvisomant (somavert)
Product Name: pegvisomant
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: pegvisomant
Sponsors
Christie Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Established diagnosis of acromegaly 2 IGF-I> upper limit of normal following washout period of current drugs 3 Age> 18 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: 1 Other conditions that may result in abnormal GH or IGF-I (e.g. severe hepatic disease, severe renal disease, malnutrition, treatment with levadopa, heroin abuse) 2 Do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures. 3 ALT or AST >3x ULN or clinically significant hepatic disease. 4 Visual field defects or other neurological symptoms due to tumour mass. 5 Have a history of relevant drug and/or food allergies or are on regular treatment with any medication that may be expected to interfere with projected study results. 6 Have received another experimental medication that may be expected to interfere with projected study results 7 Refuse to use adequate contraception to prevent pregnancy during the study 8 Are unwilling or unable to self-administer study medication on a daily basis 9 Are unable to adhere to the visit schedule outlined in the protocol 10 Have known or suspected drug/alcohol abuse 11 Women who are pregnant and women who are lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Acromegaly is a hormone disorder usually due to secretion of excess growth hormone (GH) from a pituitary tumour in the pituitary gland. Pegvisomant is a relatively new and effective treatment for acromegaly. It is currently only licensed for treatment of acromegaly which is resistant to treatment with other drugs. High doses of pegvisomant may be required in order to fully control acromegaly. This is very expensive. Cabergoline is another drug which is effective in treating acromegaly. It is relatively inexpensive but usually unable to control acromegaly completely when used alone. We would like to address the question as to whether using a combination of pegvisomant and cabergoline would allow us to use lower doses of pegvisomant to achieve good acromegaly control at significantly lower cost ; Secondary Objective: To ascertain the proportion of patients who have good acromegaly control on cabergoline alone and the dose required for this. To assess signs and symptoms of acromegaly and quality of life in patients treated with cabergoline alone and cabergoline in combination with pegvisomant. To assess some biochemical parameters which are affected by acromegaly. This includes lipids, cardiovascular risk factors and glucose tolerance. To assess serum levels of pegvisomant and whether these are affected by the presence of cabergoline. Isolated case reports exist of increased serum pegvisomant levels in the presence of somatostatin analogues. It would be pertinent to see if this was the case with cabergoline. ;Primary end point(s): The absolute IGF I values for the 30 patients after treatment with cabergoline alone, cabergoline with pegvisomant and pegvisomant alone as described in the protocol | — |
Countries
Ireland, United Kingdom
Outcome results
None listed