Acromegaly Combination Treatment Study
Acromegaly Combination Treatment Study
In this study the investigators will evaluate whether combination low dose somatostatin
 receptor ligand (SRL) and weekly or daily Pegvisomant will attain equivalent control of serum
 IGF-1 levels at a lower cost, compared to combination high dose SRL and weekly Pegvisomant.
 Lower doses of therapy will greatly reduce cost of acromegaly therapy.
Subjects will be stratified based on prior response to SRL therapy and then randomized to one
 of three treatment arms. The study will begin when the combination of octreotide LAR or
 lanreotide and pegvisomant is first administered. Study visits will occur every 4 weeks from
 the start of the study. However, for subjects who cannot make every study visit due to
 distance, the study team will facilitate monthly blood draws at their local Quest laboratory
 facility.

 After the 24 weeks of combination therapy, subjects with a controlled IGF-1 will then start
 Pegvisomant monotherapy at the same dose and schedule that they attained normalization in
 combination therapy. IGF-1 levels, liver function test, and blood glucose will be performed
 monthly. An MRI will be performed at the conclusion of the study.
Inclusion Criteria:

 -  Newly diagnosed patients with acromegaly who have not had surgery or medical therapy

 -  Acromegaly patients who are at least 3 months post surgery, who are/are not receiving
 adjuvant medical therapy

 -  Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels

 -  Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.

 -  Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week
 washout period of the dopamine agonist.

 -  Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant
 (daily or weekly

 -  Normal liver function tests before randomization to treatment

 -  The patient has had appropriate dynamic testing of the pituitary axis and, if
 applicable, is receiving appropriate hormone replacement therapy.

 Exclusion Criteria:

 -  The patient harbors a macroadenoma with visual field defects due to chiasmatic
 compression

 -  The patient has clinically significant hepatic abnormalities and/or aspartate
 aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper
 limit of normal at the baseline visit.

 -  The patient had pituitary surgery within 3 months prior to study entry

 -  The patient had radiotherapy within 12 months prior to study entry

 -  The patient has abnormal CBC and chemistry panel at the baseline visit, any other
 medical condition(s) or laboratory findings that, in the opinion of the investigator,
 might jeopardize the patient's safety.

 -  The patient has a known hypersensitivity to any of the test materials or related
 compounds.

 -  The patient has a history of, or known current problems with alcohol or drug abuse.

 -  The patient has any mental condition rendering the patient unable to understand the
 nature, scope, and possible consequences of the study, and/or evidence of an
 uncooperative attitude.