Acromegaly Combination Treatment Study

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Angiopeptin; Lanreotide; Octreotide; Somatostatin

Criteria

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.