Acromegaly Combination Treatment Study

Not Applicable

Terminated

• Conditions: Acromegaly
• Interventions: Drug: Pegvisomant; Drug: Octreotide LAR; Drug: Lanreotide

• Registration Number: NCT01538966
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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 insulin-like growth factor (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.

Detailed Description

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 long-acting release (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. Magnetic resonance imaging (MRI) will be performed at the conclusion of the study.

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Study Start: 2012-03-29
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Status Verified: 2022-08
• Results First Submitted: 2022-11-20
• Results First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Results First Posted: 2023-01-04
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose SRL + daily Pegvisomant	Pegvisomant	Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)
Low dose SRL + weekly Pegvisomant	Pegvisomant	Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
Low dose SRL + weekly Pegvisomant	Octreotide LAR	Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
High dose SRL + weekly Pegvisomant	Octreotide LAR	High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)
Low dose SRL + daily Pegvisomant	Octreotide LAR	Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)
High dose SRL + weekly Pegvisomant	Pegvisomant	High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)
High dose SRL + weekly Pegvisomant	Lanreotide	High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)
Low dose SRL + daily Pegvisomant	Lanreotide	Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)
Low dose SRL + weekly Pegvisomant	Lanreotide	Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)

Primary Outcome Measures

Name	Time	Method
Cost Effectiveness	24 weeks	We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States