Strict IGF-1 Control in Acromegaly

Study Overview
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Brief Summary
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Acromegaly is a rare, chronic, and debilitating disease, usually caused by a benign tumor on the pituitary gland, which leads to excessive production of growth hormone (GH). GH excess in turn causes overproduction of another hormone called insulin-like growth factor-1 (IGF-1). IGF-1 levels are currently the most widely accepted measure of disease activity. In Canada, medical therapy with a type of medicine called somatostatin analogues (SSA), such as octreotide and lanreotide, is recommended for treatment of acromegaly. However, studies have shown that a significant number of patients who take SSA medications alone remain with elevated levels of IGF-1 in their blood. Another medication that is used to treat acromegaly is pegvisomant (PEGV), and the investigators plan to study whether strict control of IGF-1, by adding or optimizing the use of PEGV, results in a significant health benefits to patients who still have modestly high levels of IGF-1 in their blood.

Official Title
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Strict IGF-1 Control in Acromegaly (I-Con Study)

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Pegvisomant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (at least 18 years old) with confirmed acromegaly whose IGF-I levels are persistently but modestly (1.0 ULN < [IGF-1 serum level] < 1.5 ULN) elevated following medical therapy such as SSA, PEGV, cabergoline alone or in combination. Exclusion Criteria: Progressive or recent visual field loss or optic chiasmal compression, or pituitary tumors within 2mm from the chiasm. Patients whose visual field loss, optic chiasmal compression or pituitary tumor has been stable for at least a year will be eligible. Cranial nerve palsies or intracranial hypertension requiring tumour decompression surgery Clinically significant hepatic disease and/or elevated liver enzymes (ALT, AST > 3 x ULN) Patients who have received pituitary surgery within one year prior to screening visit Patients who have received radiation therapy within one year prior to screening visit History of hypersensitivity to any components of Pegvisomant Inability to fully comprehend the nature of the study or cooperate with study procedures Pregnant / lactating women and subjects refusing to use adequate contraception to prevent pregnancy during the study. Subjects unwilling or unable to self-administer medication on a daily basis known or suspected alcohol / drug abuse Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegvisomant<br>Open-label, non-randomized single arm variable dose study of pegvisomant conducted in a real world setting. | Drug: Pegvisomant<br>* Study medications will be prescribed as per clinical practice with PEGV being added, or optimally dosed, at the Month 0 visit. Subjects who are naïve to PEGV should start their injections from 10 mg twice a week to 10 mg daily if used as combination therapy or 10 to 20 mg daily if used as monotherapy. Maximum dosing should not exceed 40mg/day. Dosing of PEGV can be adjusted as per clinical judgement to meet the normalization of IGF-1 levels (<1.0 ULN) in increments of 5-10mg/day. In the event of a reduction in IGF-1 below the LLN, the dose of PEGV could be decreased by 5-10 mg/day.<br>* Other names: Somavert;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life (AcroQoL) |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IGF-1 level |  | six months | 
| Acromegaly Disease Activity Tool (ACRODAT) | To assess acromegaly co-morbidities | six months | 
| Patient-assessed Acromegaly Symptom Questionnaire | To assess acromegaly signs and symptoms | six months | 
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment |  | six months |